- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06252844
The Impact of 6-months of Resistance Training on Brain and Muscle Health in Older Adults With MCI
The Impact of 6-months of Resistance Training on Intrinsic Capacity, Cognition, and Brain/Circulating Biomarkers of Neuroplasticity and Neuroinflammation in Older Adults With Mild Cognitive Impairment: a Randomized Controlled Trial.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vida J Česnaitienė, PhD
- Phone Number: +370 698 33646
- Email: vida.cesnaitiene@lsu.lt
Study Locations
-
-
-
Kaunas, Lithuania
- Recruiting
- Institute of Sport Science and Innovations
-
Contact:
- Nerijus Masiulis, PhD
- Phone Number: +370 60039099
- Email: nerijus.masiulis@lsu.lt
-
Principal Investigator:
- Oron Levin, PhD
-
Kaunas, Lithuania
- Recruiting
- Lithuanian Sports University
-
Contact:
- Vilma Dudoniene, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female 65+ years old,
- Community-dwelling,
- Sedentary (not engaged in any structured activity for exercise) or non-sedentary individuals who engaged in mild recreational activities for less than 150 min/week.
- A score of 18 to 25 on the Montreal Cognitive Assessment (MoCA) with or without a diagnosis of MCI. The diagnosis of MCI will be confirmed by a qualified mental health care specialist at the screening evaluation according to the International Classification of Diseases (ICD-10) and the Petersen criteria (Petersen et al, 2014).
- Fluent in Lithuanian.
Exclusion Criteria:
- Age < 65 years.
- MoCA ≥ 26 or MoCA < 18,
- Symptomatic heart or cardiopulmonary disorders, diabetes, diagnosis of renal/hepatic disease, oncology, brain injury, diagnosis of neurologic, psychiatric, or musculoskeletal diseases.
- Physical or orthopedic conditions (rheumatic symptoms, chronic pain, fractures, acute muscle injuries) that limit the subject's ability to participate in the training program.
- Moderate to severe intake of alcohol (intake of 3 drinks or more/day for men and 2 drink or more/day for women).
- Current smoker
- Intake of drugs or psychiatric medications.
- Contraindications to perform MRI (e.g., claustrophobia, cardiac pacemaker, internal pacing wires, metal implants, etc.).
- Body mass index (BMI) > 35 kg/m2 or body weight > 130 kg.
- Participation in routine exercise or physical activities (IPAQ).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Progressive resistance training (PRT) of lower limb muscles.
Frequency of intervention: 2-3 times per week.
Duration of intervention: 24 weeks.
|
Supervised PRT will consist of leg extension, leg curl, leg press, and calf raises.
Initially participants will start with a 4 weeks adaptation with low loads at 15 (repetition maximum, RM) conducting for 1-3 sets.
Further on subjects will continue with a 5 month of PRT with intensity increasing every 2 weeks from 12 to 6 RM.
Each exercise will be done for 3 sets with 2 min rest periods between sets.
After the 2 weeks at 6 RM, 1 week of rest will be applied.
After the rest week, the same cycle starting from 12 RM will be repeated until the end of intervention.
|
Experimental: Active control
Flexibility training of the lower limb muscles.
Frequency of intervention: 2-3 times per week.
Duration of intervention: 24 weeks.
|
Supervised static stretching exercises will be performed without causing an unpleasant feeling of stretching, up to pain, maintaining the stretching position for at least 30 s. Exercises will be performed slowly so that heart rate (HR) does not exceed 50% maximum.
Subjects will calculate their HR before training, in the middle and after the training measuring the pulse for 10 s.
Exercises will be repeated 3-5 times for each side of the body.
The duration of the training will be match to PRT group and will take around 40 min.
In order to keep the subjects interested and motivated, two of the stretching exercises will be changed every two weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in intrinsic capacity
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Assessment of intrinsic capacity subdomains will be conducted according to the WHO ICOPE guidelines. Outcome measures: Locomotion capacity [scale 0 to 12] with higher scores indicating a better outcome. Cognition capacity [scale: 0 to 4], with higher scores indicating a better outcome. Psychological capacity (mood) [scale: 0 to 4] with higher scores indicating a better outcome. Vitality [scale 0 to 12], with higher scores indicating a better outcome. Sensory capacity index [scale 0 to 3], with higher scores indicating a better outcome. Capacity indexes for each of the above mentioned subdomains will be calculated as the scores obtained divided by the maximum possible scores [scale 0 to 1]. The global intrinsic capacity index will be calculated as the sum of the subdomain's capacity indexes [scale 0 to 5] with higher scores indicating a better outcome. |
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in global cognition
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Outcome measure: scores on the Montreal cognitive assessment (MoCA) [range 0 - 30] with higher scores indicating better performance.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in psychological assessment of depression
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Outcome measure: scores on the Geriatric depression scale (GDS), [range 0-15] with higher score indicate severe depression.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in reaction time
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
ANAM4 cognitive test battery, including: Go/No-Go test (GNG), 6 Letter Memory Search test (6LMST), Manikin test (MNKT) Outcome measures: Reaction Time (in milliseconds) with shorter time indicating a better outcome. |
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in reaction accuracy
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
ANAM4 cognitive test battery, including: Go/No-Go test (GNG), 6 Letter Memory Search test (6LMST), Manikin test (MNKT) Outcome measures: % number of correct responses with higher value indicating a better outcome. |
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in cognitive efficiency
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
ANAM4 cognitive test battery, including: Go/No-Go test (GNG), 6 Letter Memory Search test (6LMST), Manikin test (MNKT) Outcome measures: throughput (= number of correct responses divided by mean RT for correct responses) with higher value indicating a better outcome |
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in Stroop interference score
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Stroop Color and Word test (SCWT) Outcome measure: interference score (in seconds) Interference = CWT - [(WT + CT)/2] where WT, CT, and CWT are times (in seconds) to complete the Word, Color, and Color-Word conditions, respectively. Lower interference score indicates a better outcome. |
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in performance on the Trail Making Test (TMT)
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Complete parts A and part B of the Trail Making Test Outcome measures: Time (in seconds) required to complete part A (Trail A scores) Time (in seconds) required to complete part B (Trail B scores) Shorter time indicated a better outcome. |
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in sway velocity
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Center of pressure (CoP) data will be collected in stance position with a single piezoelectric force plate (KISTLER, model 9286) under single and dual-task condition. Outcome measures: CoP sway velocity (CoPv) in ML and AP sway directions (millimiter/seconds). Lower sway velocity represents a better outcome. |
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in dual-task cost for sway velocity
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Dual task cost (DTC) will be quantified as % change of sway velocity from dual to single task relative to their single task values. Increased negative value represents a better outcome whereas increased positive value represents a worse outcome. |
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in agility
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
8-Foot timed up and go (8-foot TUG): Outcome measure: time to complete the task in seconds.
Shorter time to complete the task represents a better outcome.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in lower body strength and muscular endurance
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
30s Chair-Rise test: Outcome measure: number of sit-to-stand repetitions completed in 30 seconds.
More sit-to-stand repetitions represents a better outcome.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in levels of Albumin (Alb)
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Albumin levels [grams/deciliter (g/dL)] will be measured with GBC-system XN-1500 blood analyzer.
Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in levels of Hemoglobin (Hb)
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Hemoglobin levels [grams/deciliter (g/dL)] will be measured with GBC-system XN-1500 blood analyzer.
Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in levels of C-reactive protein (CRP)
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
CRP levels [milligrams/deciliter (mg/dL)] will be measured with COBAS PRO blood analyzer.
Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in circulating levels of cytokines
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Serum levels of the interleukins IL-1β, IL-6, IL-10, IL-18 and serum levels of TNFα [all picograms/milliliter(pg/ml)] will be assessed with enzyme-linked immunosorbent assay (ELISA).
Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Serum samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in circulating levels of Kynurenine
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Serum levels of Kynurenine [nanograms/milliliter(ng/ml)] will be assessed with enzyme-linked immunosorbent assay (ELISA).
Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Serum samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in circulating levels of brain-derived neurotrophic factor (BDNF)
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Plasma levels of BDNF [picograms/milliliter(pg/mL)] will be assessed with enzyme-linked immunosorbent assay (ELISA).
Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Plasma samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in circulating levels of Insulin-like growth factor 1 (IGF-1)
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Serum levels of IGF-1 [nanograms/milliliter(pg/mL)] will be assessed with enzyme-linked immunosorbent assay (ELISA).
Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Serum samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in circulating levels of Irisin
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Plasma levels of irisin [nanograms/milliliter (ng/ml)] will be assessed using enzyme-linked immunosorbent assay (ELISA).
Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Serum samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in circulating levels of c-terminal agrin fragment-22 (CAF22)
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Serum levels of c-terminal agrin fragment-22 [picograms/milliliter (pg/ml)] will be assessed using enzyme-linked immunosorbent assay (ELISA).
Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Serum samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in circulating levels of Neurofilament light chain (NfL)
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Plasma levels of NfL (picograms/milliliter (pg/ml)] will be assessed using enzyme-linked immunosorbent assay (ELISA).
Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Plasma samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in circulating levels of tau proteins
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Plasma levels of phosphorylated tau181 (p-tau181) and total tau (t-tau) [both, picograms/milliliter (pg/ml)] will be assessed using enzyme-linked immunosorbent assay (ELISA).
Blood samples will be collected at the at antecubital vein after 12-h fasting by a qualified medical professional.
Plasma samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in circulating levels of beta amyloids
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Plasma levels of beta amyloid 40 (Aβ40) and beta amyloid 42 (Aβ42) will be assessed using enzyme-linked immunosorbent assay (ELISA).
Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Plasma samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Plasma levels of Aβ40 and Aβ42 will be combined to calculate the Aβ42/40 ratio.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in brain volume properties
Time Frame: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Whole brain T1-weighted images, T2-wighted images, T2* relaxation images and fluid attenuated inversion recovery (FLAIR) images will be obtained.
Outcome measures will be grey matter (GM) volumes, white matter (WM) volumes (WM) and WM hyperintensity (WMH) volumes [all in cubic millimeter (mm^3)] of cortical and subcortical structures.
A total WMH volume will be obtained by summing the volumes of hyperintensities from all of the substructures.
A large WMH volume will be taken as an indicator for cerebrovascular abnormalities.
Image processing: FreeSurfaer software, version 6 (freely available).
|
Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in brain cortical thickness
Time Frame: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Whole brain T1-weighted images.
Outcome measures: GM cortical thicknesses (in mm) of cortical substructures.
Image processing: FreeSurfer software, version 6 (freely available).
|
Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in brain WM microstructural organization
Time Frame: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Participants will undergo whole brain diffusion-weighted imaging (DWI).
Outcome measures will be the Fractional anisotropy (FA) of WM tracts in the brain.
Image processing will be possible with the use of the ExploreDTI software (freely available).
|
Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in brain neurometabolic levels
Time Frame: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Single voxel proton magnetic resonance spectroscopy (1H-MRS) of left hippocampus (HPC), right dorsolateral prefrontal cortex (dlPFC) and left sensory motor cortex (SM1). Data will be processed with LC Model within the Osprey pipeline (freely available). Outcome measures will be the water-referenced levels of:
All levels are expressed in institutional units (i.u). |
Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in brain neurometabolic ratios
Time Frame: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Single voxel proton magnetic resonance spectroscopy (1H-MRS). Ratios will be calculated from water-referenced levels of NAA, Cho, mIns, Glx, and Cr in left Hippocampus, left sensorimotor cortex and right dorsolateral prefrontal cortex. Outcome measures:
Ratios are expressed in arbitrary units (a.u). |
Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in quadriceps/hamstrings cross sectional area
Time Frame: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
T1-weighted images of the left/right thighs Outcome measures:
|
Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in quadriceps myocellular lipid content
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
1H-MRS spectra from the right quadriceps. Outcome measures:
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in body composition and BMI
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
TANITA body impedance analysis. Outcome measures: total body weight, body fat mass, lean muscle mass, and bone mass (in kilograms). Total body weight and fat weight will be combined to calculate % body fat. Total body weight and height will be combined to calculate the body mass index (BMI) in kilograms/meter^2. |
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in knee muscle torque production
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Biodex
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in muscle contraction time
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Tensiomyography (TMG) of left and right rectus femoris (RF) and biceps femoris (BF) heads. Outcome measures: Delay time (Td) and contraction time (Tc) of left/right RF and BF (in milliseconds). |
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in muscle contraction displacement
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Tensiomyography (TMG) of left and right rectus femoris (RF) and biceps femoris (BF) heads. Outcome measures: Muscle contraction displacement (Dm) of left/right RF and BF (in millimeter). |
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in muscle contraction velocity
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Tensiomyography (TMG) of left and right rectus femoris (RF) and biceps femoris (BF) heads. Muscle contraction displacement (Dm), delay time (Td) and contraction time (Tc) will be combined to calculate contraction velocity (Vc) of left/right RF and BF. Vc = [Dm/(Td +Tc)] (in millimeter/second). |
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in level of fatigue
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Participants will complete the Multidimensional Fatigue Inventory (MFI-20) [range 4-20] with higher scores indicate a higher level of fatigue.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in level of frailty
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Subjects will undergo the Edmonton Frail Scale survey [range 0 -17] with higher scores indicate a higher level of frailty.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in health status
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Participants will complete the 36-Items Form Health survey (SF-36), [range 0-100] with higher score indicate better physical and mental health.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in nutritional status
Time Frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Participants will complete the Mini Nutritional Assessment (MNA) survey [range 0-14] with higher score indicate better nutritional condition.
|
Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in blood count
Time Frame: Baseline and Post-intervention time (24 weeks); Optional follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Blood count tests will be conducted using GBC-system XN-1500 blood analyzer. Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Outcome measures:
|
Baseline and Post-intervention time (24 weeks); Optional follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in lipid profiles
Time Frame: Baseline and Post-intervention time (24 weeks); Optional follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
A lipidogram test will be conducted using COBAS PRO blood analyzer. Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Outcome measures:
|
Baseline and Post-intervention time (24 weeks); Optional follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Changes in Glycosylated Hemoglobin (HbA1c)
Time Frame: Baseline and Post-intervention time (24 weeks); Optional follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Glycosylated Hemoglobin levels will be measured using the Alinity C method. Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Outcome measures: - Level of HbA1c [millimole/liter (mmol/L)]. Normal range < 42 mmol/L (~ 6%). |
Baseline and Post-intervention time (24 weeks); Optional follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
|
Self-report measure of habitual physical activity
Time Frame: Baseline
|
Participants will complete the International Physical Activity Questionnaire (IPAQ-LT).
Higher score indicate high physical activity level.
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Oron Levin, PhD, Lithuanian Sports University
Publications and helpful links
General Publications
- Petersen RC, Caracciolo B, Brayne C, Gauthier S, Jelic V, Fratiglioni L. Mild cognitive impairment: a concept in evolution. J Intern Med. 2014 Mar;275(3):214-28. doi: 10.1111/joim.12190.
- Bautmans I, Knoop V, Amuthavalli Thiyagarajan J, Maier AB, Beard JR, Freiberger E, Belsky D, Aubertin-Leheudre M, Mikton C, Cesari M, Sumi Y, Diaz T, Banerjee A; WHO Working Group on Vitality Capacity. WHO working definition of vitality capacity for healthy longevity monitoring. Lancet Healthy Longev. 2022 Nov;3(11):e789-e796. doi: 10.1016/S2666-7568(22)00200-8.
- Beard JR, Si Y, Liu Z, Chenoweth L, Hanewald K. Intrinsic Capacity: Validation of a New WHO Concept for Healthy Aging in a Longitudinal Chinese Study. J Gerontol A Biol Sci Med Sci. 2022 Jan 7;77(1):94-100. doi: 10.1093/gerona/glab226.
- Belloni G, Cesari M. Frailty and Intrinsic Capacity: Two Distinct but Related Constructs. Front Med (Lausanne). 2019 Jun 18;6:133. doi: 10.3389/fmed.2019.00133. eCollection 2019.
- Cesari M, Araujo de Carvalho I, Amuthavalli Thiyagarajan J, Cooper C, Martin FC, Reginster JY, Vellas B, Beard JR. Evidence for the Domains Supporting the Construct of Intrinsic Capacity. J Gerontol A Biol Sci Med Sci. 2018 Nov 10;73(12):1653-1660. doi: 10.1093/gerona/gly011.
- Cesari M, Sadana R, Sumi Y, Amuthavalli Thiyagarajan J, Banerjee A. What Is Intrinsic Capacity and Why Should Nutrition Be Included in the Vitality Domain? J Gerontol A Biol Sci Med Sci. 2022 Jan 7;77(1):91-93. doi: 10.1093/gerona/glab318. No abstract available.
- De Luca A, Kuijf H, Exalto L, Thiebaut de Schotten M, Biessels GJ; Utrecht VCI Study Group. Multimodal tract-based MRI metrics outperform whole brain markers in determining cognitive impact of small vessel disease-related brain injury. Brain Struct Funct. 2022 Sep;227(7):2553-2567. doi: 10.1007/s00429-022-02546-2. Epub 2022 Aug 22.
- Gallardo-Gomez D, Del Pozo-Cruz J, Noetel M, Alvarez-Barbosa F, Alfonso-Rosa RM, Del Pozo Cruz B. Optimal dose and type of exercise to improve cognitive function in older adults: A systematic review and bayesian model-based network meta-analysis of RCTs. Ageing Res Rev. 2022 Apr;76:101591. doi: 10.1016/j.arr.2022.101591. Epub 2022 Feb 17.
- Leung AYM, Su JJ, Lee ESH, Fung JTS, Molassiotis A. Intrinsic capacity of older people in the community using WHO Integrated Care for Older People (ICOPE) framework: a cross-sectional study. BMC Geriatr. 2022 Apr 8;22(1):304. doi: 10.1186/s12877-022-02980-1.
- Levin O, Netz Y, Ziv G. The beneficial effects of different types of exercise interventions on motor and cognitive functions in older age: a systematic review. Eur Rev Aging Phys Act. 2017 Dec 21;14:20. doi: 10.1186/s11556-017-0189-z. eCollection 2017.
- Levin O, Vints WAJ, Ziv G, Katkute G, Kusleikiene S, Valatkeviciene K, Sheoran S, Drozdova-Statkeviciene M, Gleizniene R, Paasuke M, Dudoniene V, Himmelreich U, Cesnaitiene VJ, Masiulis N. Neurometabolic correlates of posturography in normal aging and older adults with mild cognitive impairment: Evidence from a 1H-MRS study. Neuroimage Clin. 2023;37:103304. doi: 10.1016/j.nicl.2022.103304. Epub 2022 Dec 24.
- Netz Y. Is There a Preferred Mode of Exercise for Cognition Enhancement in Older Age?-A Narrative Review. Front Med (Lausanne). 2019 Mar 29;6:57. doi: 10.3389/fmed.2019.00057. eCollection 2019.
- Sheoran S, Vints WAJ, Valatkeviciene K, Kusleikiene S, Gleizniene R, Cesnaitiene VJ, Himmelreich U, Levin O, Masiulis N. Strength gains after 12 weeks of resistance training correlate with neurochemical markers of brain health in older adults: a randomized control 1H-MRS study. Geroscience. 2023 Jun;45(3):1837-1855. doi: 10.1007/s11357-023-00732-6. Epub 2023 Jan 26.
- Tatebe H, Kasai T, Ohmichi T, Kishi Y, Kakeya T, Waragai M, Kondo M, Allsop D, Tokuda T. Quantification of plasma phosphorylated tau to use as a biomarker for brain Alzheimer pathology: pilot case-control studies including patients with Alzheimer's disease and down syndrome. Mol Neurodegener. 2017 Sep 4;12(1):63. doi: 10.1186/s13024-017-0206-8.
- Vints WAJ, Gokce E, Langeard A, Pavlova I, Cevik OS, Ziaaldini MM, Todri J, Lena O, Sakkas GK, Jak S, Zorba Zormpa I, Karatzaferi C, Levin O, Masiulis N, Netz Y. Myokines as mediators of exercise-induced cognitive changes in older adults: protocol for a comprehensive living systematic review and meta-analysis. Front Aging Neurosci. 2023 Jul 13;15:1213057. doi: 10.3389/fnagi.2023.1213057. eCollection 2023.
- Vints WAJ, Levin O, Fujiyama H, Verbunt J, Masiulis N. Exerkines and long-term synaptic potentiation: Mechanisms of exercise-induced neuroplasticity. Front Neuroendocrinol. 2022 Jul;66:100993. doi: 10.1016/j.yfrne.2022.100993. Epub 2022 Mar 11.
- Vints WAJ, Kusleikiene S, Sheoran S, Sarkinaite M, Valatkeviciene K, Gleizniene R, Kvedaras M, Pukenas K, Himmelreich U, Cesnaitiene VJ, Levin O, Verbunt J, Masiulis N. Inflammatory Blood Biomarker Kynurenine Is Linked With Elevated Neuroinflammation and Neurodegeneration in Older Adults: Evidence From Two 1H-MRS Post-Processing Analysis Methods. Front Psychiatry. 2022 Apr 11;13:859772. doi: 10.3389/fpsyt.2022.859772. eCollection 2022.
- Kothapalli SVVN, Benzinger TL, Aschenbrenner AJ, Perrin RJ, Hildebolt CF, Goyal MS, Fagan AM, Raichle ME, Morris JC, Yablonskiy DA. Quantitative Gradient Echo MRI Identifies Dark Matter as a New Imaging Biomarker of Neurodegeneration that Precedes Tisssue Atrophy in Early Alzheimer's Disease. J Alzheimers Dis. 2022;85(2):905-924. doi: 10.3233/JAD-210503.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LithuanianSportsU-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
- The data collected in this study will be available to all collaborators in an interactive closed data repository.
- Analyzed data will be available in an open-source data repository for all researchers upon request after the end of the study.
IPD Sharing Time Frame
IPD Sharing Access Criteria
Data collected and additional supporting information will be shared unconditionally with all collaborators upon signing a Data Sharing Agreement.
Access to the open-source data repository will be granted by the principal investigator and/or study manager.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mild Cognitive Impairment
-
University of California, San FranciscoNational Institute on Aging (NIA)RecruitingMild Cognitive Impairment | Cognitive Decline | Cognitive Deterioration | Cognitive Impairment, Mild | Cognitive Deficits, MildUnited States
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Mackay Memorial HospitalBened Biomedical Co., Ltd.RecruitingMild Cognitive Impairment (MCI)Taiwan
-
Thomas Jefferson UniversityJohns Hopkins University; University of Pennsylvania; National Institute on Aging... and other collaboratorsCompletedMild Cognitive Impairment (MCI)United States
-
Palo Alto Veterans Institute for ResearchU.S. Army Medical Research and Development CommandCompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Assaf-Harofeh Medical CenterNeurim Pharmaceuticals Ltd.UnknownMild Cognitive Impairment (MCI)Israel
-
Xuanwu Hospital, BeijingWuhan University; Beijing Friendship Hospital; First Affiliated Hospital Xi'an... and other collaboratorsRecruitingAmnestic Mild Cognitive ImpairmentChina
-
Immunotec Inc.RecruitingMild Cognitive Impairment (MCI)Canada
-
Jennifer BramenNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Meir Medical CenterTerminatedMild Cognitive Impairment (MCI)Israel
Clinical Trials on Resistance exercise training
-
Bangor UniversityBetsi Cadwaladr University Health BoardCompletedChronic Kidney DiseaseUnited Kingdom
-
Florida State UniversityNutrisystem, Inc.CompletedHypertension | Obesity | Pre-hypertensionUnited States
-
Beijing Sport UniversityRecruitingHypertension | Cognitive FunctionChina
-
University of HoustonTerminated
-
Iowa State UniversityNational Institute of Mental Health (NIMH)Recruiting
-
University of Alberta, Physical EducationCanadian Breast Cancer Research AllianceCompleted
-
University of JyvaskylaRecruiting
-
Rigshospitalet, DenmarkCompleted
-
University of Kansas Medical CenterNational Strength and Conditioning Association FoundationRecruiting
-
Texas A&M UniversityRecruiting