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Online Education and Gentle Exercise Intervention (MY-Skills)

Primary Purpose

Chronic Pain, Pain

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
MY-SKILLS - online
MY-Plan control - online
Sponsored by
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Caregiving Dyad, Pain-related Disability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Colorado State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MY-Skills Intervention - online

MY-Plan control - online

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2018
Last Updated
June 18, 2021
Sponsor
Colorado State University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03440320
Brief Title
Online Education and Gentle Exercise Intervention
Acronym
MY-Skills
Official Title
Online Education and Gentle Exercise Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
May 12, 2021 (Actual)
Study Completion Date
May 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado State University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Pain
Keywords
Caregiving Dyad, Pain-related Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Online intervention
Masking
ParticipantOutcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MY-Skills Intervention - online
Arm Type
Experimental
Arm Description
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.
Arm Title
MY-Plan control - online
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MY-SKILLS - online
Intervention Description
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
Intervention Name(s)
MY-Plan control - online
Intervention Description
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..
Primary Outcome Measure Information:
Title
Brief Pain Inventory
Description
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.
Time Frame
Administered at baseline and again following the 8-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlene Schmid, PhD
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine Fruhauf, PhD
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Online Education and Gentle Exercise Intervention

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