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Effect of Functional Exercise in Patients With Spinal Bulbar Muscular Atrophy

NCT01369901 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2019-12-17

No results posted yet for this 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....

Conditions

  • Motor Neuron Disease

Interventions

BEHAVIORAL

A functional exercise program

BEHAVIORAL

A stretching exercise program

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Kenneth H Fischbeck, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-08
Completion
2018-02-28

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01369901 on ClinicalTrials.gov