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This is a clinical trial examining a brief motivational intervention to improve adherence to exercise among individuals with MS to improve fatigue.
This is a 2-arm single blind parallel group RCT comparing a brief telephone based motivational intervention to an informational control to improve adherence to exercise among individuals with MS. The primary outcome is improvement in fatigue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief telephone-based counseling | Active Comparator | Telephone based counseling and instructional video |
|
| Education Counseling | Placebo Comparator | Mailed Physical Activity information and instructional video only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief telephone-based counseling | Behavioral | Brief telephone-based counseling using Motivational Interviewing and physical activity goal setting and problem solving |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | 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. | baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity (Behavioral Target) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron P Turner, PhD | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26913621 | Result | Turner AP, Hartoonian N, Sloan AP, Benich M, Kivlahan DR, Hughes C, Hughes AJ, Haselkorn JK. Improving fatigue and depression in individuals with multiple sclerosis using telephone-administered physical activity counseling. J Consult Clin Psychol. 2016 Apr;84(4):297-309. doi: 10.1037/ccp0000086. Epub 2016 Feb 25. | |
| 31097413 | Derived |
| Label | URL |
|---|---|
| VA Multiple Sclerosis Centers of Excellence web page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telephone Counseling | Telephone based counseling and instructional video Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving |
| FG001 | Education Counseling | Exercise information and instructional video Informational video: Mailed video of exercise programs |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Telephone Counseling | Telephone based counseling and instructional video Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving |
| BG001 | Education Counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fatigue | 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. | 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. | Posted | Mean | Standard Error | units on a scale | baseline, 3 months, 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telephone Counseling | Telephone based counseling and instructional video (Intervention) Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| car accident not related to study | Cardiac disorders | Systematic Assessment | ER visit for syncopal episode after accident: hypotensive and bradycardic. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
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).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron Turner, PhD, Director, Rehabilitation Psychology; Asst Director Research, MSCOE | Rehabilitation Care Services; MS Center of Excellence (MSCOE), VA Puget Sound Health Care System | 206-277-6134 | Aaron.Turner@med.va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 22, 2009 | Sep 24, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| D009043 | Motor Activity |
| D003863 | Depression |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Education counseling | Other | Mailed informational video of exercise programs |
|
| baseline, 3 months, 6 months |
| baseline, 3 months, 6 months |
| Turner AP, Hartoonian N, Hughes AJ, Arewasikporn A, Alschuler KN, Sloan AP, Ehde DM, Haselkorn JK. Physical activity and depression in MS: The mediating role of behavioral activation. Disabil Health J. 2019 Oct;12(4):635-640. doi: 10.1016/j.dhjo.2019.04.004. Epub 2019 Apr 30. |
Exercise information and instructional video
Informational video: Mailed video of exercise programs
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Self-directed physical activity information and instructional video Informational video: Mailed video of Physical activity programs |
|
|
|
| Secondary | Depression | 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. | 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. | Posted | Mean | Standard Error | units on a scale | baseline, 3 months, 6 months |
|
|
|
|
| Other Pre-specified | Physical Activity (Behavioral Target) | 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. | 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. | Posted | Mean | Standard Error | units on a scale | baseline, 3 months, 6 months |
|
|
|
|
| 3 |
| 31 |
| 24 |
| 31 |
| EG001 | Education Counseling | Exercise information and instructional video (Control) Informational video: Mailed video of exercise programs | 4 | 33 | 18 | 33 |
|
| MS exacerbation | Nervous system disorders | Systematic Assessment | Treated with IV steroids inpatient. |
|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | Fall from ladder |
|
| Overnight hospital stay - 24 hour observation of first dose of Fingolimod | Nervous system disorders | Systematic Assessment | MS disease modifying therapy. Requires overnight observation to new users. |
|
| Routine Overnight Inpatient Hospital Stay for MS Evaluation | Nervous system disorders | Systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cut Thumb | Injury, poisoning and procedural complications | Systematic Assessment | Cut Thumb while sawing tree |
|
| Fall | Nervous system disorders | Systematic Assessment | Balance problems due to multiple sclerosis injuries from fall: twisted ankle, skinned hand, sore back, strained shoulder, |
|
| Increased MS Symptoms | Nervous system disorders | Systematic Assessment |
|
| ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Optic neuritis | Eye disorders | Systematic Assessment | from MS exacerbation |
|
| MS exacerbation | Nervous system disorders | Systematic Assessment | outpatient |
|
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| muscle soreness from exercise | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | from having bronchitis |
|
| Numbness | Nervous system disorders | Systematic Assessment | MS symptom increase |
|
| slurred speech | Nervous system disorders | Systematic Assessment | MS symptom |
|
| Mobility | Nervous system disorders | Systematic Assessment |
|
| Fatigue | Nervous system disorders | Systematic Assessment | due to MS |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
| Month 6 |
|
| ANOVA | .032 | Interaction effects between the telephone counseling and education counseling groups over time (baseline, 3 months, 6 months). | Non-Inferiority or Equivalence (legacy) | Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group X Time interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99). |
| Month 6 |
|
| ANOVA | .014 | Comparing physical activity scores for the telephone counseling and education counseling groups at 6 months. | Non-Inferiority or Equivalence (legacy) | Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99). |