Trial Outcomes & Findings for Impact of Exercise Training on Pain and Brain Function in Gulf War Veterans (NCT NCT01350492)
NCT ID: NCT01350492
Last Updated: 2020-10-20
Results Overview
The Short Form McGill Pain Questionnaire VAS ranges from 0 (No pain) to 100 (Worst possible pain). The respondent was asked to report how bad their pain has been over the past week. A higher score indicates a greater severity of pain.
COMPLETED
NA
77 participants
6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.
2020-10-20
Participant Flow
Between May 2013 and March 2018, participants were recruited through digital and print advertisements in area medical centers, presentations at Veteran Service Organizations and via a mailed letter targeting Veterans from a VA database search. The first participant was enrolled in June 2013 and the last participant was enrolled in March 2018.
Following phone screening, 119 participants were invited to participate. Of those, 77 were enrolled and underwent a more substantial screening process. 54 participants were randomly assigned to a group. The remaining 23 participants were not assigned to a group as they were ineligible (n=17) or declined to continue (n=6).
Participant milestones
| Measure |
Resistance Exercise Training
Resistance Exercise Training: 16 weeks of resistance exercise training, performed twice weekly, for the treatment of chronic muscle pain.
|
Waitlist Control
Waitlist Control: Individuals assigned to this condition were asked to maintain their usual routine while enrolled. Upon completion they were offered the opportunity to undertake the resistance training protocol.
|
|---|---|---|
|
Intervention
STARTED
|
28
|
26
|
|
Intervention
6-week MRI Scan
|
24
|
22
|
|
Intervention
11-week MRI Scan
|
23
|
21
|
|
Intervention
COMPLETED
|
23
|
20
|
|
Intervention
NOT COMPLETED
|
5
|
6
|
|
Post Intervention Follow-Up
STARTED
|
23
|
20
|
|
Post Intervention Follow-Up
6-month MRI Scan
|
20
|
20
|
|
Post Intervention Follow-Up
COMPLETED
|
17
|
18
|
|
Post Intervention Follow-Up
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Resistance Exercise Training
Resistance Exercise Training: 16 weeks of resistance exercise training, performed twice weekly, for the treatment of chronic muscle pain.
|
Waitlist Control
Waitlist Control: Individuals assigned to this condition were asked to maintain their usual routine while enrolled. Upon completion they were offered the opportunity to undertake the resistance training protocol.
|
|---|---|---|
|
Intervention
Lost to Follow-up
|
2
|
5
|
|
Intervention
Withdrawal by Subject
|
3
|
1
|
|
Post Intervention Follow-Up
Lost to Follow-up
|
6
|
1
|
|
Post Intervention Follow-Up
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Measures were considered valid if the participant wore the accelerometer for at least 10 hr/day for 4 days. In addition, one of those 4 days must have been a weekend day (i.e., Saturday or Sunday). The sample is limited to only those participants with a valid baseline measure.
Baseline characteristics by cohort
| Measure |
Resistance Exercise Training
n=28 Participants
Resistance Exercise Training: 16 weeks of resistance exercise training, performed twice weekly, for the treatment of chronic muscle pain.
|
Waitlist Control
n=26 Participants
Waitlist Control: Individuals assigned to this condition were asked to maintain their usual routine while enrolled. Upon completion they were offered the opportunity to undertake the resistance training protocol.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.71 years
STANDARD_DEVIATION 7.20 • n=28 Participants
|
50.19 years
STANDARD_DEVIATION 5.64 • n=26 Participants
|
49.94 years
STANDARD_DEVIATION 6.44 • n=54 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=28 Participants
|
4 Participants
n=26 Participants
|
11 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=28 Participants
|
22 Participants
n=26 Participants
|
43 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
White, not Hispanic
|
25 Participants
n=28 Participants
|
20 Participants
n=26 Participants
|
45 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
White Hispanic
|
2 Participants
n=28 Participants
|
3 Participants
n=26 Participants
|
5 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Black, not Hispanic
|
1 Participants
n=28 Participants
|
3 Participants
n=26 Participants
|
4 Participants
n=54 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=28 Participants
|
26 Participants
n=26 Participants
|
54 Participants
n=54 Participants
|
|
Marital Status
Married
|
15 Participants
n=28 Participants
|
21 Participants
n=26 Participants
|
36 Participants
n=54 Participants
|
|
Marital Status
Divorced
|
6 Participants
n=28 Participants
|
4 Participants
n=26 Participants
|
10 Participants
n=54 Participants
|
|
Marital Status
Never married
|
3 Participants
n=28 Participants
|
1 Participants
n=26 Participants
|
4 Participants
n=54 Participants
|
|
Marital Status
Widowed
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=54 Participants
|
|
Marital Status
Separated
|
2 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=54 Participants
|
|
Marital Status
Living as married
|
2 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=54 Participants
|
|
Education
Did not finish high school
|
0 Participants
n=28 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=54 Participants
|
|
Education
High school graduate
|
4 Participants
n=28 Participants
|
6 Participants
n=26 Participants
|
10 Participants
n=54 Participants
|
|
Education
Some college
|
11 Participants
n=28 Participants
|
6 Participants
n=26 Participants
|
17 Participants
n=54 Participants
|
|
Education
College graduate (including associates degree)
|
9 Participants
n=28 Participants
|
11 Participants
n=26 Participants
|
20 Participants
n=54 Participants
|
|
Education
Some post-graduate
|
1 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=54 Participants
|
|
Education
Graduate degree
|
3 Participants
n=28 Participants
|
2 Participants
n=26 Participants
|
5 Participants
n=54 Participants
|
|
Pain Catastrophizing Scale (PCS)
|
11.79 units on a scale
STANDARD_DEVIATION 8.72 • n=28 Participants
|
8.65 units on a scale
STANDARD_DEVIATION 7.98 • n=26 Participants
|
10.28 units on a scale
STANDARD_DEVIATION 8.44 • n=54 Participants
|
|
State Trait Anxiety Inventory (STAI) - Y2 Form
|
37.57 units on a scale
STANDARD_DEVIATION 9.94 • n=28 Participants
|
36.00 units on a scale
STANDARD_DEVIATION 9.21 • n=26 Participants
|
36.81 units on a scale
STANDARD_DEVIATION 9.54 • n=54 Participants
|
|
Beck Depression Inventory (BDI)
|
9.07 units on a scale
STANDARD_DEVIATION 6.85 • n=28 Participants
|
6.73 units on a scale
STANDARD_DEVIATION 6.62 • n=26 Participants
|
7.94 units on a scale
STANDARD_DEVIATION 6.78 • n=54 Participants
|
|
Physical Activity (Accelerometer)
|
236520 Counts per day
STANDARD_DEVIATION 114918 • n=24 Participants • Measures were considered valid if the participant wore the accelerometer for at least 10 hr/day for 4 days. In addition, one of those 4 days must have been a weekend day (i.e., Saturday or Sunday). The sample is limited to only those participants with a valid baseline measure.
|
337629 Counts per day
STANDARD_DEVIATION 165554 • n=21 Participants • Measures were considered valid if the participant wore the accelerometer for at least 10 hr/day for 4 days. In addition, one of those 4 days must have been a weekend day (i.e., Saturday or Sunday). The sample is limited to only those participants with a valid baseline measure.
|
283704 Counts per day
STANDARD_DEVIATION 148202 • n=45 Participants • Measures were considered valid if the participant wore the accelerometer for at least 10 hr/day for 4 days. In addition, one of those 4 days must have been a weekend day (i.e., Saturday or Sunday). The sample is limited to only those participants with a valid baseline measure.
|
|
Physical Activity (Self-report)
|
4820 MET-minutes/week
STANDARD_DEVIATION 6094 • n=28 Participants
|
5848 MET-minutes/week
STANDARD_DEVIATION 7410 • n=26 Participants
|
5315 MET-minutes/week
STANDARD_DEVIATION 6715 • n=54 Participants
|
|
Fractional anisotropy (FA) at the corpus callosum
|
0.528 Scalar value b/w 0-1
STANDARD_DEVIATION 0.030 • n=28 Participants
|
0.521 Scalar value b/w 0-1
STANDARD_DEVIATION 0.031 • n=26 Participants
|
0.524 Scalar value b/w 0-1
STANDARD_DEVIATION 0.030 • n=54 Participants
|
PRIMARY outcome
Timeframe: 6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.Population: Intent to treat population (all participants assigned to either resistance exercise training or wait-list control). Last observation carried forward (LOCF) imputation method.
The Short Form McGill Pain Questionnaire VAS ranges from 0 (No pain) to 100 (Worst possible pain). The respondent was asked to report how bad their pain has been over the past week. A higher score indicates a greater severity of pain.
Outcome measures
| Measure |
Resistance Exercise Training
n=28 Participants
Resistance Exercise Training: 16 weeks of resistance exercise training, performed twice weekly, for the treatment of chronic muscle pain.
|
Waitlist Control
n=26 Participants
Waitlist Control: Individuals assigned to this condition were asked to maintain their usual routine while enrolled. Upon completion they were offered the opportunity to undertake the resistance training protocol.
|
|---|---|---|
|
Short Form McGill Pain Questionnaire Visual Analog Scale (VAS).
6 months
|
31.5 units on a scale
Standard Deviation 22.31
|
34.31 units on a scale
Standard Deviation 25.66
|
|
Short Form McGill Pain Questionnaire Visual Analog Scale (VAS).
6 weeks
|
29.82 units on a scale
Standard Deviation 22.12
|
37.08 units on a scale
Standard Deviation 25.92
|
|
Short Form McGill Pain Questionnaire Visual Analog Scale (VAS).
11 weeks
|
30.07 units on a scale
Standard Deviation 22.37
|
31.46 units on a scale
Standard Deviation 21.78
|
|
Short Form McGill Pain Questionnaire Visual Analog Scale (VAS).
17 weeks
|
30.68 units on a scale
Standard Deviation 24.12
|
35.12 units on a scale
Standard Deviation 24.05
|
|
Short Form McGill Pain Questionnaire Visual Analog Scale (VAS).
12 months
|
31.68 units on a scale
Standard Deviation 23.37
|
33.58 units on a scale
Standard Deviation 26.12
|
PRIMARY outcome
Timeframe: 6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.Population: Intent to treat population (all participants assigned to either resistance exercise training or wait-list control). Last observation carried forward (LOCF) imputation method.
The PCS is a composite summary score of items from the VR-36 related to physical health. Individual subscale scores are z transformed using US normative data, multiplied by a factor score coefficient, summed, and transformed to a T-score of a distribution (Mean = 50; Standard Deviation = 10). Higher scores represent better physical health.
Outcome measures
| Measure |
Resistance Exercise Training
n=28 Participants
Resistance Exercise Training: 16 weeks of resistance exercise training, performed twice weekly, for the treatment of chronic muscle pain.
|
Waitlist Control
n=26 Participants
Waitlist Control: Individuals assigned to this condition were asked to maintain their usual routine while enrolled. Upon completion they were offered the opportunity to undertake the resistance training protocol.
|
|---|---|---|
|
Physical Component Score (PCS) From the Veterans Rand 36 Item Heath Survey (VR-36).
17 weeks
|
42.66 units on a scale, T-score transformed
Standard Deviation 5.60
|
42.92 units on a scale, T-score transformed
Standard Deviation 5.80
|
|
Physical Component Score (PCS) From the Veterans Rand 36 Item Heath Survey (VR-36).
6 weeks
|
43.01 units on a scale, T-score transformed
Standard Deviation 5.17
|
44.53 units on a scale, T-score transformed
Standard Deviation 6.06
|
|
Physical Component Score (PCS) From the Veterans Rand 36 Item Heath Survey (VR-36).
11 weeks
|
41.82 units on a scale, T-score transformed
Standard Deviation 5.95
|
43.37 units on a scale, T-score transformed
Standard Deviation 6.68
|
|
Physical Component Score (PCS) From the Veterans Rand 36 Item Heath Survey (VR-36).
6 months
|
43.03 units on a scale, T-score transformed
Standard Deviation 5.96
|
43.94 units on a scale, T-score transformed
Standard Deviation 7.07
|
|
Physical Component Score (PCS) From the Veterans Rand 36 Item Heath Survey (VR-36).
12 months
|
41.14 units on a scale, T-score transformed
Standard Deviation 5.85
|
42.99 units on a scale, T-score transformed
Standard Deviation 6.59
|
PRIMARY outcome
Timeframe: 6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.Population: Intent to treat population (all participants assigned to either resistance exercise training or wait-list control). Last observation carried forward (LOCF) imputation method. THE PGIC, however, was not administered until the 6-week in-person visit. So participants who were withdrawn or lost to follow up before the 6-week visit were not included.
The PGIC is a 7-item, self-report scale indicating the degree to which a patient has experienced any change since starting treatment. Each respondent was asked to rate "...the change (if any) in activity limitations, symptoms, emotions, and overall quality of life." related to their pain since beginning treatment. Scores range from 1, "No change (or condition has got worse)" to 7, "A great deal better, and a considerable improvement that has made all the difference." A higher score indicates greater improvement.
Outcome measures
| Measure |
Resistance Exercise Training
n=24 Participants
Resistance Exercise Training: 16 weeks of resistance exercise training, performed twice weekly, for the treatment of chronic muscle pain.
|
Waitlist Control
n=22 Participants
Waitlist Control: Individuals assigned to this condition were asked to maintain their usual routine while enrolled. Upon completion they were offered the opportunity to undertake the resistance training protocol.
|
|---|---|---|
|
Patients' Global Impression of Change (PGIC).
6 weeks
|
3.58 units on a scale
Standard Deviation 1.59
|
1.77 units on a scale
Standard Deviation 1.02
|
|
Patients' Global Impression of Change (PGIC).
11 weeks
|
3.67 units on a scale
Standard Deviation 1.52
|
2.00 units on a scale
Standard Deviation 0.87
|
|
Patients' Global Impression of Change (PGIC).
17 weeks
|
3.88 units on a scale
Standard Deviation 1.83
|
2.05 units on a scale
Standard Deviation 0.95
|
|
Patients' Global Impression of Change (PGIC).
6 months
|
3.21 units on a scale
Standard Deviation 2.00
|
2.18 units on a scale
Standard Deviation 1.47
|
|
Patients' Global Impression of Change (PGIC).
12 months
|
2.71 units on a scale
Standard Deviation 1.81
|
2.45 units on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: 6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.Population: Intent to treat population (all participants assigned to either resistance exercise training or wait-list control). Last observation carried forward (LOCF) imputation method. Sample is limited to only those participants with a valid baseline measure.
Physical activity is measured via accelerometer. The measure is a unit-less average of the number of counts per day. The higher the count, the greater the amount and intensity of physical activity accumulated over course of the day. Values range from 30,000 (sedentary) to 800,000 (highly active).
Outcome measures
| Measure |
Resistance Exercise Training
n=24 Participants
Resistance Exercise Training: 16 weeks of resistance exercise training, performed twice weekly, for the treatment of chronic muscle pain.
|
Waitlist Control
n=21 Participants
Waitlist Control: Individuals assigned to this condition were asked to maintain their usual routine while enrolled. Upon completion they were offered the opportunity to undertake the resistance training protocol.
|
|---|---|---|
|
Physical Activity (Accelerometer)
6 weeks
|
261012 Counts per day
Standard Deviation 131113
|
299872 Counts per day
Standard Deviation 124379
|
|
Physical Activity (Accelerometer)
11 weeks
|
267376 Counts per day
Standard Deviation 133327
|
321253 Counts per day
Standard Deviation 121150
|
|
Physical Activity (Accelerometer)
17 weeks
|
285157 Counts per day
Standard Deviation 181804
|
305315 Counts per day
Standard Deviation 122002
|
|
Physical Activity (Accelerometer)
6 months
|
267067 Counts per day
Standard Deviation 168249
|
295661 Counts per day
Standard Deviation 126297
|
|
Physical Activity (Accelerometer)
12 months
|
252940 Counts per day
Standard Deviation 144748
|
300769 Counts per day
Standard Deviation 132518
|
SECONDARY outcome
Timeframe: 6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.Total weekly self-reported physical activity was quantified using the International Physical Activity Questionnaire (IPAQ). The outcome is expressed as the number of metabolic equivalent (MET) minutes per week. One MET is defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min, so 1 minute spent at rest is equal to 1 MET-minute. Respondents are only asked to report on physical activity of a light intensity or greater (≥3 METs, e.g., briskly walking). Higher values equal greater amount/intensity of activity.
Outcome measures
| Measure |
Resistance Exercise Training
n=28 Participants
Resistance Exercise Training: 16 weeks of resistance exercise training, performed twice weekly, for the treatment of chronic muscle pain.
|
Waitlist Control
n=26 Participants
Waitlist Control: Individuals assigned to this condition were asked to maintain their usual routine while enrolled. Upon completion they were offered the opportunity to undertake the resistance training protocol.
|
|---|---|---|
|
Physical Activity (Self-report)
6 weeks
|
4535 MET-minutes/week
Standard Deviation 5948
|
6824 MET-minutes/week
Standard Deviation 7944
|
|
Physical Activity (Self-report)
11 weeks
|
5856 MET-minutes/week
Standard Deviation 5912
|
4978 MET-minutes/week
Standard Deviation 7601
|
|
Physical Activity (Self-report)
17 weeks
|
4629 MET-minutes/week
Standard Deviation 4280
|
6491 MET-minutes/week
Standard Deviation 9020
|
|
Physical Activity (Self-report)
6 months
|
4232 MET-minutes/week
Standard Deviation 3771
|
6273 MET-minutes/week
Standard Deviation 9161
|
|
Physical Activity (Self-report)
12 months
|
4492 MET-minutes/week
Standard Deviation 4739
|
6113 MET-minutes/week
Standard Deviation 8709
|
SECONDARY outcome
Timeframe: 6 weeks, 11 weeks, 17 weeks and 6 and 12 monthsFractional anisotropy (FA) is a scalar value between 0 and 1 that describes the degree of anisotropy of a diffusion process. In the case of brain white matter integrity, it gives us an indication of the tract integrity at a particular region within the brain. 0 would indicate flow is completely unrestricted (no integrity), 1 that all flow is in the same direction (high integrity). In this instance we are using the FA at the body of the corpus callosum as an indicator of overall brain white matter integrity.
Outcome measures
| Measure |
Resistance Exercise Training
n=28 Participants
Resistance Exercise Training: 16 weeks of resistance exercise training, performed twice weekly, for the treatment of chronic muscle pain.
|
Waitlist Control
n=26 Participants
Waitlist Control: Individuals assigned to this condition were asked to maintain their usual routine while enrolled. Upon completion they were offered the opportunity to undertake the resistance training protocol.
|
|---|---|---|
|
Brain Structure: White Matter Tract Integrity, Operationalized With Fractional Anisotropy (FA) Measures at the Body of the Corpus Callosum.
6 weeks
|
0.5263 Scalar value b/w 0 and 1
Standard Deviation 0.0310
|
0.5213 Scalar value b/w 0 and 1
Standard Deviation 0.0325
|
|
Brain Structure: White Matter Tract Integrity, Operationalized With Fractional Anisotropy (FA) Measures at the Body of the Corpus Callosum.
12 months
|
0.5219 Scalar value b/w 0 and 1
Standard Deviation 0.0343
|
0.5203 Scalar value b/w 0 and 1
Standard Deviation 0.0329
|
|
Brain Structure: White Matter Tract Integrity, Operationalized With Fractional Anisotropy (FA) Measures at the Body of the Corpus Callosum.
11 weeks
|
0.5256 Scalar value b/w 0 and 1
Standard Deviation 0.0312
|
0.5213 Scalar value b/w 0 and 1
Standard Deviation 0.0323
|
|
Brain Structure: White Matter Tract Integrity, Operationalized With Fractional Anisotropy (FA) Measures at the Body of the Corpus Callosum.
17 weeks
|
0.5261 Scalar value b/w 0 and 1
Standard Deviation 0.0298
|
0.5224 Scalar value b/w 0 and 1
Standard Deviation 0.0313
|
|
Brain Structure: White Matter Tract Integrity, Operationalized With Fractional Anisotropy (FA) Measures at the Body of the Corpus Callosum.
6 months
|
0.5262 Scalar value b/w 0 and 1
Standard Deviation 0.0303
|
0.5217 Scalar value b/w 0 and 1
Standard Deviation 0.0325
|
Adverse Events
Resistance Exercise Training
Waitlist Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Aaron J. Stegner, Ph.D.
William S. Middleton Memorial Veterans Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place