Impact of Exercise Training on Pain and Brain Function in Gulf War Veterans

NCT01350492 | Completed Results

• 1 other identifier: SPLD-004-10S
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to test the influence of weight training on physical symptoms, physical activity and brain structure and function in Gulf War Veterans with chronic widespread muscle pain.

Conditions

Chronic Musculoskeletal Pain

Keywords

pain; brain imaging; exercise

Outcome Measures

Primary Outcomes (3)

• Short Form McGill Pain Questionnaire Visual Analog Scale (VAS).

  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.

  6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.

• Physical Component Score (PCS) From the Veterans Rand 36 Item Heath Survey (VR-36).

  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.

  6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.

• Patients' Global Impression of Change (PGIC).

  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.

  6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.

Secondary Outcomes (3)

• Physical Activity (Accelerometer)

  6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.

• Physical Activity (Self-report)

  6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.

• Brain Structure: White Matter Tract Integrity, Operationalized With Fractional Anisotropy (FA) Measures at the Body of the Corpus Callosum.

  6 weeks, 11 weeks, 17 weeks and 6 and 12 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Resistance exercise training

Behavioral: Resistance Exercise Training

Arm 2

NO INTERVENTION

Waitlist Control

Interventions

Resistance Exercise Training BEHAVIORAL

16 weeks of resistance exercise training for the treatment of chronic muscle pain compared to wait-list control

Arm 1

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran of the Persian Gulf War
• Chronic muscle pain

You may not qualify if:

• Regular participation in resistance exercise
• Color blindness
• Claustrophobia
• Medical conditions that could explain the Veteran's pain
• Major depressive disorder with melancholic features
• Substance abuse
• Schizophrenia
• Bipolar disorder

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Pain; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Aaron J. Stegner, Ph.D.
• Organization: William S. Middleton Memorial Veterans Hospital

aaron.stegner@va.gov

608-262-1290

Study Officials

• Dane B. Cook, PhD

  William S. Middleton Memorial Veterans Hospital, Madison, WI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 9, 2011
• Study Start: April 16, 2013
• Primary Completion: June 18, 2019
• Study Completion: June 18, 2019
• Last Updated: October 20, 2020
• Results First Posted: July 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)