Physical Activity Promotion Added to Standard Care Pulmonary Rehabilitation and Cognitive Behavioural Therapy

NCT03749655 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-04-05

No results posted yet for this study

Summary

In patients with Chronic Obstructive Pulmonary Disease (COPD) daily physical activity is reduced compared to healthy age-matched individuals. Reduced levels of physical activity in patients with COPD are associated with increased risk for exacerbations, hospital admissions and mortality.

Pulmonary rehabilitation (PR) constitutes standard care for patients with COPD as it improves exercise capacity, quality of life and reduces the risk for exacerbation and hospitalisation. Participation in PR, however, does not necessarily translate into improved daily physical activity levels. It is currently uncertain whether addition of physical activity promotion strategies to standard PR programs induces an improvement in daily physical activity along with exercise capacity and quality of life compared to pulmonary rehabilitation alone.

Physical activity (PA) is a complex health behaviour that is modified by behavioural change interventions. PA promotion programs through the use of wearable monitors (i.e. pedometers, accelerometers) with goal setting and feedback, have shown to increase daily physical activity, but not exercise capacity or quality of life in COPD patients. Therefore, combination of both PR and PA promotion strategies is necessary to translate PR-induced improvements in functional capacity into improved daily physical activity level. The investigators propose to perform a feasibility study assessing patient adherence to PA promotion incorporated into a standard PR program. To enhance adherence to the PA promotion strategy, Cognitive Behavioural Modification Strategies (CBM) will be provided to patients undertaking PR. CBM strategies facilitate the goals of PR as they address several behavioural barriers including anxiety, depression and physical inactivity, and constitutes an important component in the management of COPD to improve engagement with PR and promote a physically active lifestyle. The investigators will divide patients into two programs: one including PR, PA promotion and CBM and the other comprising standard PR and CBM provision. The investigators will compare patients' adherence (16 sessions of PR) to both programs.

Conditions

Interventions

BEHAVIORAL

Physical Activity Promotion

The physical activity (PA) promotion intervention will be provided only to the intervention group, and will include: 1) a step-counter with a digital display, 2) an interview discussing motivational issues, favourite daily activities and strategies to become more physically active; and 3) a tailored physical activity coaching plan including an Individualised activity goal (in steps/day) revised twice weekly through consultation sessions (16 sessions in total). Patients' targets will be revised twice weekly during the consultation sessions which will be incorporated into the Pulmonary rehabilitation sessions. The aim is to increase physical activity by 10% each week. The goal can be altered if required.

Sponsors & Collaborators

  • Newcastle-upon-Tyne Hospitals NHS Trust

    collaborator OTHER
  • Northumbria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2021-04-01
Completion
2021-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03749655 on ClinicalTrials.gov