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NCT04616638 · ClinicalTrials.gov registry record · NA
Effects of Guided Exercise on Functional Performance and Independence in Adults With Intellectual Disability
A NA study of Obesity and Exercise, sponsored by University of Delaware.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04616638: Completed NA study of Obesity and Exercise, sponsored by University of Delaware.
NCT04616638 is a NA study of Obesity and Exercise that has completed, run by University of Delaware. The registered enrollment target is 24 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04616638, a NA study of Obesity and Exercise, has completed, sponsored by University of Delaware.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Adults with intellectual disabilities (ID) have significantly lower levels of fitness compared to the general population. The health benefits of enhanced muscular strength in the general population are well established. In adults with ID, increased muscular strength levels are positively associated with improved aerobic capacity and performance of functional tasks. A concerted effort has been made to design and evaluate resistance training (RT) interventions aimed at increasing muscular strength in adults with ID. While the findings are encouraging, the small number of published studies, missing or poorly described theoretical frameworks or familiarization protocols that guided the RT interventions, and compromised methodological quality raise questions about the actual effects of these interventions and warrant further investigation. The primary purpose of this study is to design and pilot test the effects of an innovative community-based multi-component RT program, Resistance Training for Empowerment (RT-POWER). The primary aim of RT-POWER is to improve muscular strength and independent functional performance in adults with ID. The trial is guided by the SCT theoretical framework. Adults with ID will be randomly allocated to either an experimental group (EG) or a control group (CG). The EG will receive the RT-POWER intervention and the CG will receive an RT intervention traditionally used with the general population. Stage 1 will consist of six familiarization sessions (2 per week for 3 weeks) and Stage 2 will consist of 20 RT sessions (2 per week for 10 weeks). Five hypotheses will be tested: (a) The EG will demonstrate significantly greater increases on the chest-press and leg-press one-repetition maximum (1-RM) tests from baseline to Week 15 compared with the CG; (b) The EG will demonstrate significantly greater increases on the plank test from baseline to Week 15 compared with the CG; (c) The EG will demonstrate significantly greater increases on the six-minut
Primary Outcome
Upper-body and lower-body muscular strength will be measured with the chest-press and the leg-press 1-RM tests (ACSM, 2018), respectively. Each testing session will start with a warm-up set of 6-10 repetitions, with approximately 50% of the estimated resistance. Loads will be estimated with the repetitions-to-fatigue method. Participants will be given 3 attempts. For each attempt, participants will be asked to complete 2 repetitions at the same speed of movement and range of motion. If a partici
Conditions Studied
Interventions
- BEHAVIORAL Resistance Training for Empowerment (RT-POWER)
- BEHAVIORAL A traditional RT intervention
Study Locations (1)
Delaware
- University of Delaware - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-01-17 |
| Est. Completion | 2019-07-31 |
| Phase | NA |
What the finished NCT04616638 record still lists
NCT04616638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Resistance Training for Empowerment (RT-POWER) is the first listed.
NCT04616638 reports a single indexed study location in Delaware.
Frequently Asked Questions
What is clinical trial NCT04616638 about?
NCT04616638 is a clinical study titled "Effects of Guided Exercise on Functional Performance and Independence in Adults With Intellectual Disability". Adults with intellectual disabilities (ID) have significantly lower levels of fitness compared to the general population. The health benefits of enhanced muscular strength in the general population are well established. In adults with ID, increased muscular strength levels are positively associated ...
What is the current status of trial NCT04616638?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2018-01-17. Estimated completion is 2019-07-31.
What conditions does trial NCT04616638 study?
This clinical trial studies the following conditions: Obesity, Exercise, Intellectual Disability.
What interventions are being tested in trial NCT04616638?
The interventions under investigation include: Resistance Training for Empowerment (RT-POWER) (BEHAVIORAL), A traditional RT intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04616638?
This trial is sponsored by University of Delaware, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04616638 being conducted?
This trial has 1 study location across Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04616638's enrollment target sits among peer trials
24 909th of 1053 higher than 127 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
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