- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03765385
The Umeå High-Intensity Training Study (Umeå HIT)
October 2, 2020 updated by: Umeå University
The Umeå High-Intensity Training Study: Feasibility and Effect of High-Intensity Training in Older Sedentary People
This randomized controlled trial will evaluate the effect of high-intensity training (HIT) in older sedentary people.
Seventy older people, aged 65 and over, will be randomized to HIT or moderate-intensity continuous training (MICT).
HIT sessions will consist of 10 repeated 6-seconds regulated high intensity cycling sprints against an individualized load.
MICT (control group) sessions will consist of aerobic training regulated against an individualized load set to reach a moderate submaximal exercise intensity.
Both groups will be performed twice weekly for 12 weeks.
The study will evaluate the effects on 1) Cardiovascular function, 2) Brain health, 3) Muscular function, 4) Psychological health, 5) Physical activity, 6) Metabolic health, and 7) Examine the feasibility (attendance, achieved intensity, adverse events) as well as the experiences of HIT.
Most outcomes will be assessed at baseline, 3 months (directly after intervention period), and 9 months by blinded assessors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Information about modifications of the study protocol (September 2020): Experiences of exercising and its effects were at the 9-month follow-up collected through individual interviews instead of focus group interviews (secondary outcome measures no.
31).
Due to Covid-19, at the 9-month follow-up all outcome measurements besides the questionnaire (secondary outcome measures no 9, 10, 11, 12, and 14) and interviews (secondary outcome measure no 31) were terminated for 37 of the participants.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Umeå, Sweden
- Umeå University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Not regularly physically active at moderate or high intensity over the last year.
- Independent in activities of daily living (ADL) and able to transfer from home to exercise facility.
Exclusion Criteria:
- Chronic and progressive neurological diseases.
- Movement related conditions and functions (e.g. pain) or heart and lung conditions and diseases that prohibit exercise or tests, based on screening by a physician.
- Cognitive impairment (Mini-Mental State Examination score below 27)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High-intensity training
Each high-intensity training (HIT) session will consist of 10 repeated 6-seconds regulated high intensity cycling sprints against an individualized load set to reach a supramaximal exercise intensity (i.e.
power output is higher than power output at maximum oxygen uptake).
Session duration for HIT is 20 min, including warm-up and cool-down.
The protocol enables controlled and systematic adjustments of training intensity by means of standardized criteria.
|
Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.
|
ACTIVE_COMPARATOR: Moderate-intensity continuous training
Each moderate-intensity continuous training (MICT) session will consist of aerobic training regulated against an individualized load set to reach a moderate submaximal exercise intensity (i.e.
power output is lower than power output at maximum oxygen uptake).
Session duration for MICT is 40 min, including warm-up and cool-down.
The protocol enables controlled and systematic adjustments of training intensity by means of standardized criteria.
|
Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline cardiovascular capacity at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
Maximum oxygen uptake (VO2 max)
|
Baseline, 3 months, 9 months
|
Change from baseline cognitive function at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
Measured using standardized tests covering: episodic memory (free recall, paired associates), executive functions (n-back, Trail Making Test (TMT) 4, flanker task), visuospatial ability (spatial relations), working memory (digit span) and processing speed (Trail Making Test (TMT) 2 and 3).
The cognitive tasks are first z-transformed and then everaged to form a unit-weighted cognitive score as well as domain specific constructs.
|
Baseline, 3 months, 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline brain function at 3 months.
Time Frame: Baseline, 3 months
|
Assessed using functional MRI (fMRI) using two paradigms.
Test A will estimate functional brain response during working memory manipulation and maintenance.
Test B will estimate brain response during a pattern completion/separation paradigm.
Separate analyses will be performed for fMRI paradigm A and B respectively.
For each paradigm changes of % signal BOLD change will be analysed.
|
Baseline, 3 months
|
Change from baseline brain structure at 3 months.
Time Frame: Baseline, 3 months
|
Assessed using standard MRI-sequences including T1w, T2w, T2-FLAIR.
For structural MRI data volume (mm3) and cortical thickness (mm) will be the unit of measure.
|
Baseline, 3 months
|
Change from baseline strength in knee extensors at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
Maximal isometric strength in knee extensor measured as normalized joint torque in newton meters per kilogram bodyweight (Nm/kg).
|
Baseline, 3 months, 9 months
|
Change from baseline hand grip strength at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
Maximal hand grip strength measured as normalized force in Newtons per kilogram bodyweight (N/kg).
|
Baseline, 3 months, 9 months
|
Change from baseline leg extensor muscle power at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
Leg extensor power in the Nottingham Power Rig, measured as peak power output (watt).
|
Baseline, 3 months, 9 months
|
Change from baseline functional performance at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
Chair-stand test, number of chair-stands during 30 seconds.
|
Baseline, 3 months, 9 months
|
Change from baseline functional balance at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
One-leg stance: number of seconds able to stand on one leg (maximum 120 seconds).
|
Baseline, 3 months, 9 months
|
Change from baseline functional balance at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
Step test, number of steps during 30 seconds.
|
Baseline, 3 months, 9 months
|
Change from baseline anxiety and depression at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
Hospital anxiety and depression scale (HAD): range 0-42, higher score indicates more symptoms.
|
Baseline, 3 months, 9 months
|
Change from baseline health related quality of life at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
Short Form Health Survey (SF-36): scores transformed to 0 to 100, higher scores indicates better quality of life.
|
Baseline, 3 months, 9 months
|
Change from baseline self-efficacy at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
Swedish Exercise Self Efficacy Scale (ESES-S): Range 10-40, higher score indicates more self efficacy.
|
Baseline, 3 months, 9 months
|
Change from baseline sleep quality at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
One question (no. 3) regarding sleep from Montgomery-Åsberg Depression Rating Scale (MADRS).
|
Baseline, 3 months, 9 months
|
Change from baseline objective physical activity at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
Time Frame: Baseline, 1.5 months, 3 months, 9 months
|
Physical activity measured by an activity monitor, the Actigraph.
Number of steps per day and number of activity counts per day will be measured.
|
Baseline, 1.5 months, 3 months, 9 months
|
Change from baseline self-reported physical activity at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
Time Frame: Baseline, 1.5 months, 3 months, 9 months
|
Two indicator questions on physical activity from the Swedish National Board of Health and Welfare.
|
Baseline, 1.5 months, 3 months, 9 months
|
Change from baseline metabolic health at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
Oral glucose tolerance test (OGTT):blood glucose in mmol/l,
|
Baseline, 3 months, 9 months
|
Change from baseline lipid profile at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
Lipid profile, measured by total cholesterol as well as separately as LDL- cholesterol and HDL-cholesterol.
Unit of measure is mmol/l.
|
Baseline, 3 months, 9 months
|
Change from baseline inflammation markers at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
C-reactive protein (CRP) in blood sample, units of measure is mg/l.
|
Baseline, 3 months, 9 months
|
Change from baseline inflammation markers at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
Interleukins in blood sample, units of measure is pg/ml.
|
Baseline, 3 months, 9 months
|
Change from baseline neurotrophic factors at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
Insulin-like growth factor 1 (IGF-1), units of measure is pg/ml.
|
Baseline, 3 months, 9 months
|
Change from baseline neurotrophic factors at 3 months and at 9 months, respectively.
Time Frame: Baseline, 3 months, 9 months
|
Brain-derived neurotrophic factor (BDNF), units of measure is pg/ml.
|
Baseline, 3 months, 9 months
|
Change from baseline blood pressure at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
Time Frame: Baseline, 1.5 months, 3 months, 9 months
|
Blood pressure at rest, measured as systolic ans diastolic pressure in mmHg.
|
Baseline, 1.5 months, 3 months, 9 months
|
Change from baseline resting heart rate at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
Time Frame: Baseline, 1.5 months, 3 months, 9 months
|
Resting heart rate, measured as beats per minute.
|
Baseline, 1.5 months, 3 months, 9 months
|
Change from baseline autonomic function at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
Time Frame: Baseline, 1.5 months, 3 months, 9 months
|
Heart rate variability (HRV), measured in the time domain (e.g.
RMSSD) and frequency domain (LF:HF).
|
Baseline, 1.5 months, 3 months, 9 months
|
Applicability of the interventions
Time Frame: Through the whole 3-month intervention period
|
Attendance: number of sessions attended.
|
Through the whole 3-month intervention period
|
Applicability of the interventions
Time Frame: Through the whole 3-month intervention period
|
Absolute work-load during training in Watt.
|
Through the whole 3-month intervention period
|
Applicability of the interventions
Time Frame: Through the whole 3-month intervention period
|
Relative training intensity, as percentage of MAP (Maximum Aerobic Power output).
|
Through the whole 3-month intervention period
|
Applicability of the interventions
Time Frame: Through the whole 3-month intervention period
|
Relative training intensity, as percentage of MHR (maximum heart rate).
|
Through the whole 3-month intervention period
|
Applicability of the interventions
Time Frame: Through the whole 3-month intervention period
|
Perceived exertion during training, measured with the Borg Rating of perceived exertion scale (RPE)
|
Through the whole 3-month intervention period
|
Applicability of the interventions
Time Frame: Through the whole 3-month intervention period
|
Adverse events, discomfort or chest pain during training measured with the Borg Category ratio scale (CR-10).
|
Through the whole 3-month intervention period
|
Applicability of the interventions
Time Frame: Through the whole 3-month intervention period
|
Affective state during training session using Feeling Scale, range -5 to 5, higher score indicates better feeling.
|
Through the whole 3-month intervention period
|
Experiences of exercising and its effects
Time Frame: 3 months, 9 months.
|
Focus group interviews.
|
3 months, 9 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Erik Rosendahl, Professor, Umeå University
- Principal Investigator: Carl-Johan Boraxbekk, Professor, Umeå University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 13, 2018
Primary Completion (ACTUAL)
February 5, 2020
Study Completion (ACTUAL)
July 10, 2020
Study Registration Dates
First Submitted
November 26, 2018
First Submitted That Met QC Criteria
December 3, 2018
First Posted (ACTUAL)
December 5, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 5, 2020
Last Update Submitted That Met QC Criteria
October 2, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Dnr 2018-307-31M
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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 Aged
-
Samsung ElectronicsCompletedAged | Adults | Middle Age | Aged, 80 and OverKorea, Republic of
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingAged | Patient Safety | Aged, 80 and Over | Restraint, PhysicalSpain
-
University Hospital, ToulouseNot yet recruiting
-
The Hong Kong Polytechnic UniversityThe University of Hong Kong; Education University of Hong KongRecruiting
-
Abbott NutritionCompleted
-
Pontificia Universidad Catolica de ChileNot yet recruiting
-
National Yang Ming UniversityCompleted
Clinical Trials on High-intensity training
-
University of MichiganCompletedGlucose IntoleranceUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; University of Southern DenmarkCompletedMyositis | Dermatomyositis | Polymyositis | Immune-Mediated Necrotizing MyopathyDenmark
-
University of Alabama at BirminghamRecruitingCerebral Palsy | Physical Disability | Posture Disorders in Children | Muscle DisorderUnited States
-
Universiti Putra MalaysiaCompletedHealthy AgingMalaysia
-
University of California, Los AngelesCompletedPsychotic Disorders | Mood DisordersUnited States
-
Universita di VeronaUnknown
-
Hasselt UniversityKU Leuven; Maastricht UniversityRecruitingLow Back Pain | Chronic Pain | Chronic Low-back PainBelgium
-
Universidade Federal de Sao CarlosConselho Nacional de Desenvolvimento Científico e TecnológicoCompletedChronic Obstructive Pulmonary DiseaseBrazil
-
Riphah International UniversityCompletedPolycystic Ovary SyndromePakistan
-
Karen Brorup Heje PedersenCompletedHealthy Subjects | Spinal and Bulbar Muscular AtrophyDenmark