Clinical trial NCT03440320: Online Education and Gentle Exercise Intervention
Official title: Online Education and Gentle Exercise Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Pain
Keywords: Caregiving Dyad
Pain-related Disability
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2018-02-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Online intervention
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The long-term goal of this study is to advance best practices in complementary and integrative health (CIH) to improve health for caregivers and individuals with chronic disabilities. This proposal is focused on merging exercise and education to improve pain for individuals in a caregiving dyad. The objective of this study is to develop and test the online Education and Gentle Exercise intervention, thus, addressing the critical need for innovative pain interventions focusing on the caregiving dyad. To achieve this objective and support a future randomized controlled trial (RCT), the researchers will conduct a mixed-methods study, including a small RCT.

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 online 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 be assigned to one of the the two groups. The primary hypothesis is that the online Education and Gentle Exercise intervention 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 online 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. To assess change on the primary outcome (pain-related disability) and secondary outcome measures, members of the caregiving dyad will complete pre and post-assessments guided by the Biopsychosocial model.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Brief Pain Inventory
timeFrame: Administered at baseline and again following the 8-week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado State University
name: Arlene Schmid, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Colorado State University
name: Christine Fruhauf, PhD
role: PRINCIPAL_INVESTIGATOR
References: