Online Education and Gentle Exercise Intervention

Completed · Not applicable

Conditions studied: Chronic Pain, Pain

In brief

Aim 1: Develop and manualize the Education and Gentle Exercise intervention. Using focus groups, clinical reasoning, literature, and findings from previously tested interventions of yoga and self-management, the researchers will develop, refine, and standardize the Education and Gentle Exercise intervention for chronic pain. In parallel, the researchers will develop a control group that includes exercise and health and wellness education. The expected outcomes include Education and Gentle Exercise intervention workbooks for participants and training and teaching manuals for interventionists leading the Education and Gentle Exercise intervention group and control group. Aim 2: Assess feasibility and acceptability of an online intervention, the Education and Gentle Exercise and research procedures including planned assessments. In this small RCT, the researchers will examine feasibility and acceptability of the 8-week Education and Gentle Exercise procedures and intervention compared to an exercise and health and wellness education control group. Participants will include 30 caregiving dyads randomly assigned to the two groups (15 dyads for Education and Gentle Exercise, and 15 dyads for control group; N = 30 dyads/60 participants). The primary hypothesis is that Education and Gentle Exercise will be feasible and acceptable to caregiving dyads, as measured by benchmarks for recruitment, screening, attendance, and completion of assessments and intervention. Surveys will be administered and focus groups will be conducted to understand participant satisfaction and experiences with Education and Gentle Exercise. After each intervention session, interventionists, caregivers, and care recipients will rate their satisfaction with the session content and activities.

Key facts

Study ID

NCT03440320

Run by

Colorado State University

People needed

32

Starts

2018-03-29

Expected to finish

2021-05-12

Last updated by the study team

2025-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Both members of the caregiving dyad:
• Chronic musculoskeletal pain, present for a minimum of three months
• Moderate or high levels of daily pain-related disability (BPI ≥ 5)
• Part of caregiving dyad
• Adults age 18 and over and able to speak English
• Score >4 out of 6 on the short Mini Mental Status Exam
• Ability to stand with or without an assistive device
• Sedentary lifestyle (i.e., any waking behavior characterized by an energy expenditure ≤1.5 metabolic equivalents while in a sitting or reclining posture)
• Inclusion for care recipient only:
• Living at home in the community (with or without caregiver)
• Inclusion for caregiver only:
• Identified as the primary caregiver
• Caregiver at least the past six months

You may not qualify if…

• Significant cardiovascular disease: New York Heart Association functional class 3 or 4 congestive heart failure; systolic blood pressure ≥ 180 or diastolic blood pressure ≥ 105 mmHg; myocardial infarction within 3 months, chest pain or dizziness with exercise
• Stroke, or Transient Ischemic Attack within 6 months
• Respiratory conditions requiring use of oxygen at home (i.e., COPD)
• Receiving or planning to receive, cancer treatment in the next 6 months
• Alzheimer's disease, dementia; expectation of death in the next 12 months
• In current physical rehabilitation, drug/alcohol treatment, or exercise research study
• Completed self-management education in the last year

Where it is running

• Colorado State University — Fort Collins, Colorado, United States

Full record on ClinicalTrials.gov

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