Promoting Physical Activity Behavior in Persons With Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Matthew Plow, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01572207
First received: March 28, 2012
Last updated: January 22, 2015
Last verified: January 2015
Results First Received: August 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Multiple Sclerosis
Interventions: Behavioral: Immediate exercise
Behavioral: Delayed exercise

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Immediate Exercise Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
Delayed Exercise Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.

Participant Flow:   Overall Study
    Immediate Exercise     Delayed Exercise  
STARTED     14     16  
COMPLETED     12     13  
NOT COMPLETED     2     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Immediate Exercise Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
Delayed Exercise Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
Total Total of all reporting groups

Baseline Measures
    Immediate Exercise     Delayed Exercise     Total  
Number of Participants  
[units: participants]
  14     16     30  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     16     30  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  47  ± 9     48  ± 10     47.5  ± 9.5  
Gender  
[units: participants]
     
Female     14     16     30  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     14     16     30  



  Outcome Measures
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1.  Primary:   Changes From Baseline in Physical Activity Behavior   [ Time Frame: Each subject will be given the questionnaire at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline). ]

2.  Secondary:   Changes From Baseline in Physical Fitness   [ Time Frame: Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline). ]

3.  Secondary:   Changes From Baseline in Quality of Life   [ Time Frame: Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Matthew Plow
Organization: Case Western Reserve University
phone: 216-368-8969
e-mail: map208@case.edu


No publications provided


Responsible Party: Matthew Plow, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01572207     History of Changes
Other Study ID Numbers: 10-531, 1R03HD060073-01A1
Study First Received: March 28, 2012
Results First Received: August 7, 2013
Last Updated: January 22, 2015
Health Authority: United States: Institutional Review Board