Telehealth-Based Exercise Program to Treat Fatigue in MS (MS-FIT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01198977
First received: September 8, 2010
Last updated: August 9, 2016
Last verified: August 2016
Results First Received: August 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Multiple Sclerosis
Interventions: Behavioral: Brief telephone-based counseling
Other: Education counseling

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Telephone Counseling

Telephone based counseling and instructional video

Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving

Education Counseling

Exercise information and instructional video

Informational video: Mailed video of exercise programs


Participant Flow:   Overall Study
    Telephone Counseling     Education Counseling  
STARTED     31     33  
COMPLETED     30     33  
NOT COMPLETED     1     0  
Lost to Follow-up                 1                 0  



  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.
Participants were individuals with MS recruited through (a) outpatient clinics at Veterans Affairs (VA) Puget Sound Health Care System, (b) targeted mailings to veterans in the VA MS National Data Repository who lived within the state of Washington, and (c) non-VA community-based MS support groups in the greater Puget Sound area.

Reporting Groups
  Description
Telephone Counseling

Telephone based counseling and instructional video

Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving

Education Counseling

Exercise information and instructional video

Informational video: Mailed video of exercise programs

Total Total of all reporting groups

Baseline Measures
    Telephone Counseling     Education Counseling     Total  
Number of Participants  
[units: participants]
  31     33     64  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     31     30     61  
>=65 years     0     3     3  
Age  
[units: years]
Mean (Standard Deviation)
  52.7  (11.6)     53.6  (13.1)     53.1  (12.3)  
Gender  
[units: participants]
     
Female     9     14     23  
Male     22     19     41  
Race/Ethnicity, Customized  
[units: participants]
     
Non-Hispanic, White     27     26     53  
Other     4     7     11  
Region of Enrollment  
[units: participants]
     
United States     31     33     64  



  Outcome Measures
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1.  Primary:   Fatigue   [ Time Frame: baseline, 3 months, 6 months ]

2.  Secondary:   Depression   [ Time Frame: baseline, 3 months, 6 months ]

3.  Other Pre-specified:   Physical Activity (Behavioral Target)   [ Time Frame: baseline, 3 months, 6 months ]


  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
Only ambulatory individuals were enrolled, thus high exclusion rate due to ambulation status. Outcome and mediating variables measured by validated self-report methods. A broad range of physical activity levels were included (most were low).


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Aaron Turner, PhD, Director, Rehabilitation Psychology; Asst Director Research, MSCOE
Organization: Rehabilitation Care Services; MS Center of Excellence (MSCOE), VA Puget Sound Health Care System
phone: 206-277-6134
e-mail: Aaron.Turner@med.va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01198977     History of Changes
Other Study ID Numbers: B4972-W
Study First Received: September 8, 2010
Results First Received: August 9, 2016
Last Updated: August 9, 2016
Health Authority: United States: Federal Government