Online Education and Gentle Exercise Intervention

Pain Clinical Trial

— MY-Skills  

Official title:

Online Education and Gentle Exercise Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03440320
• Other study ID #: 17-7581H
• Secondary ID: R34AT009688
• Status: Completed
• Phase: Early Phase 1
• Start date: March 29, 2018
• Est. completion date: May 12, 2021

Study information

• Verified date: June 2021
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 12, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Intervention

Behavioral:
• 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
• 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..

Locations

Country	Name	City	State
United States	Colorado State University	Fort Collins	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Colorado State University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain Inventory	Change from baseline in pain on the Brief Pain Inventory scale following the 8-week intervention. The measure scores range from 0 to 10 with higher scores indicating more severe pain and greater interference. Reported scores indicate the change in scores from baseline to 8-weeks (after the intervention), with a potential range from -10 to 10. Negative scores would indicate and improvement (decrease) in pain severity and interference, while positive scores indicate an increase in pain severity and interference.	Administered at baseline and again following the 8-week intervention