- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04022707
High Speed Circuit Training and Cognition
15 maj 2020 uppdaterad av: Joseph Signorile, University of Miami
The Impact of Circuit Resistance Training on Cognition and Estimated Maximal Oxygen Consumption in Older Adults.
The purpose of this research study is to see if a weight training program can make a positive change in participant fitness as measured by the ability to use oxygen and help the participant remember things.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The purpose of this research study is to see if a weight training program can make a positive change in cardiac fitness, that is a person's ability to use oxygen; and, if the program can help a person's memory, as measured by some standard tests.
The researchers will also ask the participant to attend two sessions with researchers at the Bascom-Palmer Eye Institute so they can take pictures of the participants' eyes to see how training changes the number of blood vessels.
This can be used by doctors and other clinicians to evaluate improvements blood flow to the brain due to training.
Studietyp
Interventionell
Inskrivning (Faktisk)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Florida
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Coral Gables, Florida, Förenta staterna, 33147
- Laboratory of Neruomuscular Research and Active Aging
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Coral Gables, Florida, Förenta staterna, 33146-2416
- Max Orovitz Laboratories
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
60 år till 85 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Men and women between 60 and 85 years of age (inclusive)
- Ability to provide informed consent
- No medical contraindication to participation in an exercise program including unstable or active untreated major medical illness (i.e., cardiovascular disease, neurological or neuromuscular diseases, stroke, cancer, etc.).
Exclusion Criteria:
- Existing muscle-skeletal injury
- Mini-mental score <18
- Enrolled in another exercise program
- Unstable or active major medical illness
- Answer "Yes" to any questions on the Elder PAR-Q
- Pregnancy
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: High-Velocity Resistance Circuttraining (HVRCT)
The participants will perform three circuits of 11 exercises that target the upper and lower body.
Training will gradually increase over the first three weeks from 1 to 3 circuits.
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The program will include three circuits of 11 exercises that target the upper and lower body.
Training will gradually increase over the first three week from 1 to 3 circuits.
Andra namn:
Lectures on health and fitness
Andra namn:
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Experimentell: Educational Control (CON)
A supervised program will be provided to the participants that includes lectures on health and fitness.
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The program will include three circuits of 11 exercises that target the upper and lower body.
Training will gradually increase over the first three week from 1 to 3 circuits.
Andra namn:
Lectures on health and fitness
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Changes in Cognition due to training
Tidsram: Baseline, Week 14
|
The MoCA will be used to detect mild cognitive impairment in the participants.
The total possible score is 30 points; a score of 26 or above is considered normal.
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Baseline, Week 14
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Submaximal cycle ergometer test to measure aerobic capacity
Tidsram: Baseline, Week 14
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The Young Men's Club of America (YMCA) cycle ergometer test will be used to compute aerobic capacity using heart rate(HR).
Predicted oxygen consumption will be computed using the HR of the last two consecutive workloads performed and the maximum workload.
A maximal oxygen consumption of 36 milliliters per kilogram body weight per minute and above is considered excellent for men, while 30 milliliters per kilogram body weight per minute is considered excellent for women.
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Baseline, Week 14
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Change in episodic memory
Tidsram: Baseline, Week 14
|
The National Institutes of Health (NIH) Toolbox: Picture Sequence Memory Test measures episodic memory.
Participants are asked to reproduce a sequence of pictures that is shown on the screen.
Participants are given credit for each adjacent pair of pictures they correctly place (i.e., if pictures in locations 7 and 8 are placed in that order and adjacent to each other anywhere, such as slots 1 and 2, one point is awarded), up to the maximum value for the sequence, which is one less than the sequence length or 17.
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Baseline, Week 14
|
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Change in attention and inhibitory control
Tidsram: Baseline, Week 14
|
The NIH Toolbox Flanker test measures attention and inhibitory control.
Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it.
This computed score ranges from 0-10, but if the score is less than 4, it indicates that the participant did not score high enough in accuracy (80 percent correct or less) to receive a reaction time score.
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Baseline, Week 14
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Change in working memory
Tidsram: Baseline, Week 14
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The NIH Toolbox List Sorting test measures working memory.
Participant recalls and sequences different visually and orally presented stimuli.
List Sorting is scored by summing the total number of items correctly recalled and sequenced on 1-List and 2-List, which can range from 0-26.
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Baseline, Week 14
|
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Change in speed of cognitive processing
Tidsram: Baseline, Week 14
|
The NIH Toolbox Pattern Comparison Processing Speed test measures speed of processing.
Participants discern whether two side-by-side pictures are the same or not, with 85 seconds to respond to as many items as possible.
Items are simple so as to purely measure processing speed.
The participant's raw score is the number of items answered correctly in 85 seconds of response time, with a range of 0-130.
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Baseline, Week 14
|
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Changes in the power muscles can produce
Tidsram: Baseline, Week 14
|
The participants will stand up and down 3 times with a thin string attached to the participant's belt.
A total of five attempts will be performed by each participant, and the highest power output will be selected for use in the analysis.
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Baseline, Week 14
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Change in retinal microvascular density as a marker of cortical changes
Tidsram: Baseline, Week 14
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Retinal microvascular density will be assessed using the Retinal Function Imager (RFI) scan protocol and Optical Coherence Tomography Angiography (OCTA).
Pictures will be taken of the subject's retina as they look into a special self-contained camera system.
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Baseline, Week 14
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in body fat-free mass
Tidsram: Baseline, Week 14
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Fat-free mass will be measured using a Tanita BC-418 bioelectrical impedance scale.
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Baseline, Week 14
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Changes in body weight
Tidsram: Baseline, Week 14
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Body weight will be measured on an electronic scale
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Baseline, Week 14
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 augusti 2019
Primärt slutförande (Faktisk)
30 april 2020
Avslutad studie (Faktisk)
30 april 2020
Studieregistreringsdatum
Först inskickad
10 juli 2019
Först inskickad som uppfyllde QC-kriterierna
16 juli 2019
Första postat (Faktisk)
17 juli 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 maj 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 maj 2020
Senast verifierad
1 maj 2020
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 20190518
Plan för individuella deltagardata (IPD)
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NEJ
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