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The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain (WATCH for Pain)

Primary Purpose

COPD, Chronic Musculoskeletal Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Every Step Counts-Tai Chi
Usual Care
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring physical activity, mindful movement, videoconference

Eligibility Criteria

40 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female participants, aged 40 and older Clinical diagnosis of COPD defined as history of cigarette consumption of > 10 pack-years, and either a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) < 0.70 or chest computerized tomography (CT) evidence of emphysema* Numeric Rating Scale pain score > 3 for > 3 months Self-reported ability to walk a minimum of one block, bend at the hip, and transfer weight from one leg to another Ability to complete 800 feet walk with Fitbit Inspire-2 recording > 90% accuracy to detect steps compared to manual counts* Have access to a computer or smartphone with Internet connection or willing to come to study site to use study computers Have access to videoconferencing audio and video capabilities Competent to provide informed consent and willingness to make return study visits Different criteria are used if baseline study visit is a virtual one. Exclusion Criteria: COPD exacerbation in the previous 1 month Clinical signs of unstable cardiovascular disease (active coronary artery disease, congestive heart failure, uncontrolled atrial fibrillation, or uncontrolled hypertension) Oxygen saturation < 85% recorded on baseline 4-meter walk* High fall risk (unable to perform 5 chair stand tests) Inability to ambulate Inability to complete questionnaires Inability to collect at least 7 of 10 days of baseline step counts Active substance abuse Participation in a regular exercise (i.e., MOVE! or Gerofit) or Tai Chi program in the previous 3 months Concurrent participation in another interventional research study Receipt of hospice or end-of-life palliative care Active medical intervention that would cause a meaningful increase in pain such as surgery, chemotherapy, or radiation therapy Different criteria are used if baseline study visit is a virtual one.

Sites / Locations

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Every Step Counts-Tai Chi

Usual Care

Arm Description

The intervention is ESC-TC which is a web-based platform (Every Step Counts) to promote walking combined with pain management content, an online Tai Chi video library, and synchronous Tai Chi classes led by an instructor via teleconference. The intervention is delivered remotely.

Usual Care

Outcomes

Primary Outcome Measures

Physical Function measured by Daily Step Counts
The FitBit pedometer will objectively-measure physical activity as daily step counts.

Secondary Outcome Measures

Pain Intensity
The 11-point Numeric Rating Scale (0=no pain; 10=worst pain imaginable) will assess pain intensity.
Dyspnea
Dyspnea will be assessed using the mMRC scale (responses 0-4 with 4 being the most dyspneic).
Pain Interference
The Interference subscale of the West Haven-Yale Multidimensional Pain Inventory will assess pain-related interference, with higher scores representing greater interference.
Dyspnea
UCSD Shortness of Breath Questionnaire with 24 items. Scores range from 0 to 120.

Full Information

First Posted
January 5, 2023
Last Updated
October 11, 2023
Sponsor
VA Office of Research and Development
Collaborators
University of Michigan, Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05701982
Brief Title
The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain
Acronym
WATCH for Pain
Official Title
The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of Michigan, Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Persons with COPD benefit from being physically active, but they are often limited by chronic musculoskeletal pain. This project will determine whether a non-pharmacologic, integrated, technology-mediated walking and Tai Chi mindfulness intervention can improve physical function in Veterans with COPD and chronic musculoskeletal pain. The proposed research addresses VA Rehabilitation R&D Service's high priority area of improving health-related quality of life by reducing disease burden and maximizing function in Veterans with chronic disease.
Detailed Description
Current physical activity (PA) interventions for persons with chronic obstructive pulmonary disease (COPD) focus primarily on reducing the debilitating symptom of dyspnea, or shortness of breath. However, over half of patients with COPD experience chronic musculoskeletal pain which limits achievement of PA goals and optimization of physical function. Low PA is associated with poor outcomes-increased risk of COPD acute exacerbations, hospitalizations, and death-independent of lung function. Funded by Rehabilitation R&D, the investigators have developed Every Step Counts (ESC), a web-based intervention to promote PA in Veterans with COPD. ESC couples a dynamic website with a pedometer that objectively monitors daily step counts. Based on the Behavioral Theory of Self-Regulation, the website provides individualized step-count goals, iterative feedback, education on disease self-management, motivation, and an online community of social support. In RCTs, the investigators have demonstrated ESC's safety, feasibility, and efficacy to increase PA over 3-6 months. However, not all participants increased daily step counts. In secondary analyses, the investigators identified pain as a significant barrier to PA. Participants with co-occurring pain and dyspnea walked 1,200-1,400 fewer steps per day, compared to those with no symptoms. In its current form, ESC does not focus on pain management. Tai Chi (TC) is an attractive nonpharmacologic treatment for chronic musculoskeletal pain. TC improves neuromuscular function, core strength, and lower limb proprioception. Importantly, the mindfulness embedded in TC uniquely addresses cognitive and psycho-emotional processes critical for pain management (i.e., "extinction of fear conditioning, acceptance-based coping strategies, increased ability to self-regulate affective appraisal of nociceptive input," and reduced pain-related distress and catastrophizing). The investigators have shown that persons with COPD can safely engage with TC delivered via either in-person classes or video instruction. The investigators propose to integrate ESC and TC to target biopsychosocial mechanisms of pain to break the chronic pain cycle and improve physical function in persons with COPD. The investigators will adapt ESC with pain management content, an online TC video library, and synchronous TC classes led by an instructor via teleconference. The investigators will randomize participants 1:1 to ESC-TC or usual care for 6 months. Assessments of outcomes will occur at baseline, 2, 4, and 6 months in all participants, and at 12 months in a subset who enroll early. Aim 1: Determine the efficacy of the ESC-TC intervention in 136 persons with COPD and chronic musculoskeletal pain to improve the primary outcome of physical function, measured by daily step count, compared to usual care at 6 months. Aim 2: Evaluate the effect of the ESC-TC intervention on secondary outcomes of (a) pain intensity and interference, (b) dyspnea, (c) health-related quality of life, (d) mobility, (e) depression, (f) exercise self-efficacy, (g) kinesiophobia, (h) pain catastrophizing, and (i) sleep quality. Aim 3: Explore the long-term effects of ESC-TC on symptoms and risk of acute exacerbations and COPD-related hospitalizations at 12 months in approximately 96 participants. The innovative multimodal, web-based, non-pharmacologic intervention to treat chronic musculoskeletal pain has potential to expand access to exercise as a rehabilitation strategy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Chronic Musculoskeletal Pain
Keywords
physical activity, mindful movement, videoconference

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention is ESC-TC which is delivered remotely. It a web-based platform (Every Step Counts) to promote walking combined with pain management content, an online Tai Chi video library, and synchronous Tai Chi classes led by an instructor via teleconference. The investigators will randomize participants 1:1 to ESC-TC or usual care for 6 months.
Masking
InvestigatorOutcomes Assessor
Masking Description
The PI and study staff who conduct follow-up visits for outcome assessments will be blinded to each participant's randomization group.
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Every Step Counts-Tai Chi
Arm Type
Experimental
Arm Description
The intervention is ESC-TC which is a web-based platform (Every Step Counts) to promote walking combined with pain management content, an online Tai Chi video library, and synchronous Tai Chi classes led by an instructor via teleconference. The intervention is delivered remotely.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Every Step Counts-Tai Chi
Intervention Description
The intervention is ESC-TC which is a web-based platform (Every Step Counts) to promote walking combined with pain management content, an online Tai Chi video library, and synchronous Tai Chi classes led by an instructor via teleconference. The intervention is delivered remotely.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual Care
Primary Outcome Measure Information:
Title
Physical Function measured by Daily Step Counts
Description
The FitBit pedometer will objectively-measure physical activity as daily step counts.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
The 11-point Numeric Rating Scale (0=no pain; 10=worst pain imaginable) will assess pain intensity.
Time Frame
6 months
Title
Dyspnea
Description
Dyspnea will be assessed using the mMRC scale (responses 0-4 with 4 being the most dyspneic).
Time Frame
6 months
Title
Pain Interference
Description
The Interference subscale of the West Haven-Yale Multidimensional Pain Inventory will assess pain-related interference, with higher scores representing greater interference.
Time Frame
6 months
Title
Dyspnea
Description
UCSD Shortness of Breath Questionnaire with 24 items. Scores range from 0 to 120.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female participants, aged 40 and older Clinical diagnosis of COPD defined as history of cigarette consumption of > 10 pack-years, and either a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) < 0.70 or chest computerized tomography (CT) evidence of emphysema* Numeric Rating Scale pain score > 3 for > 3 months Self-reported ability to walk a minimum of one block, bend at the hip, and transfer weight from one leg to another Ability to complete 800 feet walk with Fitbit Inspire-2 recording > 90% accuracy to detect steps compared to manual counts* Have access to a computer or smartphone with Internet connection or willing to come to study site to use study computers Have access to videoconferencing audio and video capabilities Competent to provide informed consent and willingness to make return study visits Different criteria are used if baseline study visit is a virtual one. Exclusion Criteria: COPD exacerbation in the previous 1 month Clinical signs of unstable cardiovascular disease (active coronary artery disease, congestive heart failure, uncontrolled atrial fibrillation, or uncontrolled hypertension) Oxygen saturation < 85% recorded on baseline 4-meter walk* High fall risk (unable to perform 5 chair stand tests) Inability to ambulate Inability to complete questionnaires Inability to collect at least 7 of 10 days of baseline step counts Active substance abuse Participation in a regular exercise (i.e., MOVE! or Gerofit) or Tai Chi program in the previous 3 months Concurrent participation in another interventional research study Receipt of hospice or end-of-life palliative care Active medical intervention that would cause a meaningful increase in pain such as surgery, chemotherapy, or radiation therapy Different criteria are used if baseline study visit is a virtual one.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marilyn L Moy, MD
Phone
(857) 203-6622
Email
Marilyn.Moy@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyn L. Moy, MD
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130-4817
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niquel Ortega
Phone
857-364-5669
Email
Niquel.Ortega@va.gov
First Name & Middle Initial & Last Name & Degree
Carole L Palumbo, PhD
Phone
(857) 364-4754
Email
cpalumbo@bu.edu
First Name & Middle Initial & Last Name & Degree
Marilyn L. Moy, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A Final De-identified, Anonymized Dataset will be created and shared upon request.

Learn more about this trial

The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain

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