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NCT01369901 · ClinicalTrials.gov registry record · Phase 1
Effect of Functional Exercise in Patients With Spinal Bulbar Muscular Atrophy
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT01369901 is a Phase 1 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 61 participants.
The verdict
NCT01369901, a Phase 1 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
Background: -Spinal and bulbar muscular atrophy (SBMA) is an inherited disorder that affects men. People with SBMA often have weakness throughout the body, including the muscles they use for swallowing, breathing, and speaking. We do not know if exercise helps or harms people with SBMA. Objective: -To see if a 12-week program of either functional exercise or stretching exercises will improve strength, function, or quality of life in people with SBMA Eligibility: * Participants will be men 18 years of age or older who have genetic confirmation of SBMA. * They must be able to walk at least 50 feet with or without an assistive device such as a cane or a walker and stand for 10 minutes without using an assistive device. * They must have access to a computer with an Internet connection. Design: * At the first visit to NIH (2 days), participants will have a medical history taken and undergo a physical exam. They will also have blood tests and an EKG, and complete questionnaires about mood, health, and exercise. Tests of muscle strength, balance, and endurance will also be done. * Participants who qualify for the study will receive instruction about either strengthening or stretching exercises. They will do these exercises at home one to three times a week for 12 weeks. * They will wear a small activity monitor while they exercise and record their exercise in a diary. * At the end of 12 weeks, participants will return to the NIH for 2 days. They will undergo the same tests as they had on the first visit. * Participants will receive follow-up phone calls and e-mails during the study and for 4 weeks after the last visit....
Interventions
- BEHAVIORAL A functional exercise program
- BEHAVIORAL A stretching exercise program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2011-06-08 |
| Est. Completion | 2018-02-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01369901
The ClinicalTrials.gov registry entry for NCT01369901 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which A functional exercise program is the first listed.
NCT01369901 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01369901 about?
NCT01369901 is a clinical study titled "Effect of Functional Exercise in Patients With Spinal Bulbar Muscular Atrophy". Background: -Spinal and bulbar muscular atrophy (SBMA) is an inherited disorder that affects men. People with SBMA often have weakness throughout the body, including the muscles they use for swallowing, breathing, and speaking. We do not know if exercise helps or harms people with SBMA. Objective:...
What is the current status of trial NCT01369901?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2011-06-08. Estimated completion is 2018-02-28.
What interventions are being tested in trial NCT01369901?
The interventions under investigation include: A functional exercise program (BEHAVIORAL), A stretching exercise program (BEHAVIORAL).
Who is sponsoring clinical trial NCT01369901?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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