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Education and Gentle Exercise Intervention (MY-Skills)

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ClinicalTrials.gov Identifier: NCT03440320
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Arlene Schmid, Colorado State University

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 Exerciseintervention group and control group.

Aim 2: Assess feasibility and acceptability of 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.


Condition or disease Intervention/treatment Phase
Chronic Pain Pain Behavioral: MY-SKILLS Behavioral: MY-SKILLS control Not Applicable

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 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 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. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes 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).

Primary Purpose: Treatment
Official Title: Education and Gentle Exercise Intervention
Actual Study Start Date : March 29, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MY-Skills Intervention
Participants will complete an 8-week, 16 session class. Each class will consist of approxmiately an hour of yoga and self-management designed to meet the needs of a caregiving dyad with chronic pain.
Behavioral: MY-SKILLS
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

Active Comparator: MY-SKILLS control
Participants will complete an 8-week, 16 session class. Each class will consist of approxmiately an hour of exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain.
Behavioral: MY-SKILLS control
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 Measures :
  1. Brief Pain Inventory [ Time Frame: Administered at baseline and again following the 8-week intervention ]
    Brief Pain Inventory scores range from 0 to 10 with higher scores indicating more severe pain and greater interference



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440320


Contacts
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Contact: Arlene Schmid, PhD (970) 491-7562 arlene.schmid@colostate.edu
Contact: Christine Fruhauf, PhD christine.fruhauf@colostate.edu

Locations
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United States, Colorado
Colorado State University Recruiting
Fort Collins, Colorado, United States, 80523
Contact: Arlene Schmid, PhD    970-491-7562    arlene.schmid@colostate.edu   
Principal Investigator: Christine A Fruhauf, PhD         
Sponsors and Collaborators
Colorado State University
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Arlene Schmid, PhD Colorado State University
Principal Investigator: Christine Fruhauf, PhD Colorado State University

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Responsible Party: Arlene Schmid, Co-Prinicipal Investigator, Colorado State University
ClinicalTrials.gov Identifier: NCT03440320     History of Changes
Other Study ID Numbers: 17-7581H
R34AT009688 ( U.S. NIH Grant/Contract )
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arlene Schmid, Colorado State University:
Caregiving Dyad
Pain-related Disability
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms