RECRUITING

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

Conditions

COPD Chronic Musculoskeletal Pain physical activity mindful movement videoconference

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-01-03

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05701982

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Marilyn L Moy, MD

CONTACT

(857) 203-6622

Marilyn.Moy@va.gov

Principal Investigator

Marilyn L. Moy, MD

PRINCIPAL_INVESTIGATOR

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

Study Locations (Sites)

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

Boston, Massachusetts, 02130-4817

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Marilyn L. Moy, MD, PRINCIPAL_INVESTIGATOR, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-03

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2024-01-03

Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

physical activity
mindful movement
videoconference

Additional Relevant MeSH Terms

COPD
Chronic Musculoskeletal Pain