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Effects of Guided Exercise on Functional Performance and Independence in Adults With Intellectual Disability
NCT04616638 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04616638
The ClinicalTrials.gov registry entry for NCT04616638 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Delaware, which has 159 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04616638 reports 1 study location spanning 1 distinct geographic area — top geographies include Delaware. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04616638?
This trial is sponsored by University of Delaware, which has 159 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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