Online Education and Gentle Exercise Intervention

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-29

Study Completion Date

2021-05-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Yoga Vs. Stretching on Chronic Back Pain

NCT00447668

Chronic Non-specific Low Back Pain

COMPLETED PHASE2

Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations

NCT01343927

Back Pain Lower Back Chronic

COMPLETED NA

Yoga, Education, and Nidra (YEN) for Chronic Low Back Pain: A Pilot Study on Pain Modulation, Well-Being, and Sleep

NCT06979713

Low Back Pain

NOT_YET_RECRUITING NA

Evaluating Yoga for Chronic Low Back Pain

NCT00056212

Low Back Pain

COMPLETED NA

Physical Activity on Neurophysiologic Gene Expression Profiles of Chronic Low Back Pain

NCT03637998

Chronic Low Back Pain Self-Management

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Online intervention

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Demographic data and measures will be collected by a blinded and trained research assistant.

The assessor and participants will be blinded to the randomization. We will maintain assessor and participant blinding through established mechanisms (e.g., not discussing information or intervention).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MY-Skills Intervention - online

Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of light exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain.

Group Type EXPERIMENTAL

MY-SKILLS - online

Intervention Type BEHAVIORAL

Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of yoga and an hour of self-management designed to meet the needs of a caregiving dyad with chronic pain

MY-Plan control - online

Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of light exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain.

Group Type ACTIVE_COMPARATOR

MY-Plan control - online

Intervention Type BEHAVIORAL

Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain..

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MY-SKILLS - online

Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of yoga and an hour of self-management designed to meet the needs of a caregiving dyad with chronic pain

Intervention Type BEHAVIORAL

MY-Plan control - online

Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain..

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes