Trial Outcomes & Findings for Telehealth-Based Exercise Program to Treat Fatigue in MS (NCT NCT01198977)
NCT ID: NCT01198977
Last Updated: 2019-10-09
Results Overview
Modified Fatigue Inventory Scale (MFIS) at baseline, 3-month, 6-month MFIS consisted of 21 items, ranging from 0 (never) to 4 (almost always). The total score was 0 to 84.
COMPLETED
NA
64 participants
baseline, 3 months, 6 months
2019-10-09
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
33
|
|
Overall Study
COMPLETED
|
30
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Telehealth-Based Exercise Program to Treat Fatigue in MS
Baseline characteristics by cohort
| Measure |
Telephone Counseling
n=31 Participants
Telephone based counseling and instructional video
Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving
|
Education Counseling
n=33 Participants
Exercise information and instructional video
Informational video: Mailed video of exercise programs
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
53.1 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, White
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
33 participants
n=7 Participants
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 monthsPopulation: Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.
Modified Fatigue Inventory Scale (MFIS) at baseline, 3-month, 6-month MFIS consisted of 21 items, ranging from 0 (never) to 4 (almost always). The total score was 0 to 84.
Outcome measures
| Measure |
Telephone Counseling
n=30 Participants
Telephone based counseling and instructional video
Intervention of brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving
|
Education Counseling
n=33 Participants
Self-directed physical activity information and instructional video
Informational video: Mailed video of Physical activity programs
|
|---|---|---|
|
Fatigue
Baseline
|
53.78 units on a scale
Standard Error 2.67
|
49.65 units on a scale
Standard Error 2.54
|
|
Fatigue
Month 3
|
45.76 units on a scale
Standard Error 3.01
|
50.53 units on a scale
Standard Error 2.86
|
|
Fatigue
Month 6
|
44.73 units on a scale
Standard Error 2.78
|
49.70 units on a scale
Standard Error 2.65
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 monthsPopulation: Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.
Depression Module of the Patient Health Questionnaire (PHQ-9). 9-item self-report instrument designed to identify depressive symptoms consistent with criteria for major depressive episode in the Diagnostic and Statistical Manual for Mental Disorders, 4th Edition. Each item is rated over the last 2 weeks: 0 (not at all), 1 (several days), 2 (more than half the days), or 3 (nearly every day). Total Score for 9 items = 27.
Outcome measures
| Measure |
Telephone Counseling
n=30 Participants
Telephone based counseling and instructional video
Intervention of brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving
|
Education Counseling
n=33 Participants
Self-directed physical activity information and instructional video
Informational video: Mailed video of Physical activity programs
|
|---|---|---|
|
Depression
Baseline
|
11.38 units on a scale
Standard Error 0.99
|
10.54 units on a scale
Standard Error 0.95
|
|
Depression
Month 3
|
9.55 units on a scale
Standard Error 1.08
|
10.86 units on a scale
Standard Error 1.03
|
|
Depression
Month 6
|
7.90 units on a scale
Standard Error 1.02
|
10.85 units on a scale
Standard Error 0.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 3 months, 6 monthsPopulation: Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.
First item of the Godin Leisure-Time Exercise Questionnaire (GLTEQ). GLTEQ asks participants to indicated the number of days per week they engaged in strenuous (e.g., running), moderate (e.g., easy bicycling), and mild (e.g., easy walking) exercise activities for periods of 15 min or more. Total weekly frequency is then calculated using an algorithm that multiplies the frequency of activities by 9 (strenuous), 5 (moderate), or 3 (mild) metabolic equivalents and sums each to produce a total level of physical activity in MET/min per week.
Outcome measures
| Measure |
Telephone Counseling
n=30 Participants
Telephone based counseling and instructional video
Intervention of brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving
|
Education Counseling
n=33 Participants
Self-directed physical activity information and instructional video
Informational video: Mailed video of Physical activity programs
|
|---|---|---|
|
Physical Activity (Behavioral Target)
Baseline
|
16.37 units on a scale
Standard Error 3.54
|
14.79 units on a scale
Standard Error 3.37
|
|
Physical Activity (Behavioral Target)
Month 3
|
29.68 units on a scale
Standard Error 3.72
|
19.74 units on a scale
Standard Error 3.54
|
|
Physical Activity (Behavioral Target)
Month 6
|
31.06 units on a scale
Standard Error 3.19
|
15.43 units on a scale
Standard Error 3.04
|
Adverse Events
Telephone Counseling
Education Counseling
Serious adverse events
| Measure |
Telephone Counseling
n=31 participants at risk
Telephone based counseling and instructional video (Intervention)
Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving
|
Education Counseling
n=33 participants at risk
Exercise information and instructional video (Control)
Informational video: Mailed video of exercise programs
|
|---|---|---|
|
Cardiac disorders
car accident not related to study
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
|
Nervous system disorders
MS exacerbation
|
3.2%
1/31 • Number of events 1 • 6 months
|
6.1%
2/33 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Fall
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
|
Nervous system disorders
Overnight hospital stay - 24 hour observation of first dose of Fingolimod
|
0.00%
0/31 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
|
Nervous system disorders
Routine Overnight Inpatient Hospital Stay for MS Evaluation
|
0.00%
0/31 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Telephone Counseling
n=31 participants at risk
Telephone based counseling and instructional video (Intervention)
Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving
|
Education Counseling
n=33 participants at risk
Exercise information and instructional video (Control)
Informational video: Mailed video of exercise programs
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
12.9%
4/31 • Number of events 4 • 6 months
|
15.2%
5/33 • Number of events 8 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain
|
9.7%
3/31 • Number of events 3 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Cut Thumb
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
|
Nervous system disorders
Fall
|
19.4%
6/31 • Number of events 7 • 6 months
|
9.1%
3/33 • Number of events 3 • 6 months
|
|
Nervous system disorders
Increased MS Symptoms
|
6.5%
2/31 • Number of events 2 • 6 months
|
0.00%
0/33 • 6 months
|
|
Gastrointestinal disorders
ulcer
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
|
Eye disorders
Optic neuritis
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
|
Nervous system disorders
MS exacerbation
|
6.5%
2/31 • Number of events 2 • 6 months
|
6.1%
2/33 • Number of events 2 • 6 months
|
|
Blood and lymphatic system disorders
anemia
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
|
Musculoskeletal and connective tissue disorders
muscle soreness from exercise
|
6.5%
2/31 • Number of events 2 • 6 months
|
0.00%
0/33 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/31 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
|
Nervous system disorders
Numbness
|
6.5%
2/31 • Number of events 2 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
|
Nervous system disorders
slurred speech
|
0.00%
0/31 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
|
Nervous system disorders
Mobility
|
3.2%
1/31 • Number of events 1 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
|
Nervous system disorders
Fatigue
|
6.5%
2/31 • Number of events 2 • 6 months
|
9.1%
3/33 • Number of events 3 • 6 months
|
Additional Information
Aaron Turner, PhD, Director, Rehabilitation Psychology; Asst Director Research, MSCOE
Rehabilitation Care Services; MS Center of Excellence (MSCOE), VA Puget Sound Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place