Online Education and Gentle Exercise Intervention

NCT03440320 | Completed Results DMC

• 2 other identifiers: 17-7581HR34AT009688
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Pain

Keywords

Caregiving Dyad; Pain-related Disability

Outcome Measures

Primary Outcomes (1)

• 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. Caregiver and care receiver completed the assessment on their own pain.

  Administered at baseline and again following the 8-week intervention

Study Arms (2)

MY-Skills Intervention - online

EXPERIMENTAL

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.

Behavioral: MY-SKILLS - online

MY-Plan control - online

ACTIVE COMPARATOR

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.

Behavioral: MY-Plan control - online

Interventions

MY-SKILLS - online 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-Skills Intervention - online

MY-Plan control - online 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..

MY-Plan control - online

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• Living at home in the community (with or without caregiver)
• 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

Sponsors & Collaborators

• Colorado State University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Related Publications (2)

• Schmid AA, Fruhauf CA, Fox AL, Sharp JL, Portz JD, Leach HJ, Van Puymbroeck M. A pilot study to establish feasibility and acceptability of a yoga and self-management education intervention to support caregivers and care receivers with persistent pain. Front Rehabil Sci. 2024 Oct 3;5:1397220. doi: 10.3389/fresc.2024.1397220. eCollection 2024.

  PMID: 39421567 DERIVED

• Portz JD, Schmid A, Fruhauf C, Fox A, Van Puymbroeck M, Sharp J, Leach H. Acceptability of Online Yoga Among Individuals With Chronic Conditions and Their Caregivers: Qualitative Study. JMIR Form Res. 2023 May 24;7:e39158. doi: 10.2196/39158.

  PMID: 37223971 DERIVED

MeSH Terms

Conditions

Chronic Pain; Pain

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Very specific inclusion and exclusion criteria (requiring high levels of pain severity and interference and low levels of physical activity) may have limited our ability to recruit a larger number of eligible individuals.

Results Point of Contact

• Title: Dr Arlene Schmid
• Organization: Colorado State University

arlene.schmid@colostate.edu

970-491-7562

Study Officials

• Arlene Schmid, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

• Christine Fruhauf, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Prinicipal Investigator

Model Details: Online intervention

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 22, 2018
• Study Start: March 29, 2018
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2021
• Last Updated: June 13, 2025
• Results First Posted: July 9, 2021

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)