Impact of Feedback on Physical Activity and Health-related Outcomes During Pulmonary Rehabilitation in COPD

NCT02725931 | Completed

• 1 other identifier: SFRH /BD/81328/2011
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to investigate whether providing feedback on physical activity (PA) levels to patients with Chronic Obstructive Pulmonary Disease (COPD) is feasible and enhances daily PA and health-related outcomes during pulmonary rehabilitation (PR). Patients will participate in a 12-week PR program and a PA-focused intervention. Patients' daily PA will be monitored during the first (W1), seventh (W7) and 12th (W12) weeks of the PR program using the activity monitors GT3X+ (ActiGraph, Pensacola, FL) and feedback will be given to them in the following weeks. Each participant will also receive individualised recommendations to improve or maintain their PA levels, based on the results of the previous week. It is expected that, by receiving individualised feedback and goals regarding their PA levels during the PR program, patients with COPD will become more active and improve their health-related outcomes.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic obstructive pulmonary disease; COPD; Pulmonary rehabilitation; Physical activity; Exercise

Outcome Measures

Primary Outcomes (1)

• Change in physical activity levels

  Physical activity data will be collected using a triaxial accelerometer. Number of steps per day and time spent in sedentary, light and moderate-to-vigorous intensity activities will be assessed. Time spent in different postures (i.e., standing, sitting and lying) will also be determined.

  weeks 1, 7 and 12

Secondary Outcomes (6)

• Change in exercise capacity

  immediately before (week 1) and after (week 12) the PR program

• Change in peripheral muscle strength

  immediately before (week 1) and after (week 12) the PR program

• Change in activities limitation resulting from breathlessness

  immediately before (week 1) and after (week 12) the PR program

• Change in functional balance

  immediately before (week 1) and after (week 12) the PR program

• Change in health-related quality of life

  immediately before (week 1) and after (week 12) the PR program

Study Arms (1)

Activity group

EXPERIMENTAL

Pulmonary rehabilitation plus physical activity intervention

Behavioral: Pulmonary rehabilitation (PR) plus PA-focused intervention

Interventions

Pulmonary rehabilitation (PR) plus PA-focused intervention BEHAVIORAL

Patients will enrol in a 12-week PR program comprising exercise training (3 times per week) and psychosocial support and education sessions (once a week). Patients will also have their PA levels monitored on weeks (W) 1, 7 and 12 and receive feedback in the following weeks.

Activity group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
• ≥ 18 years old
• clinical stability for 1 month prior to the study (no hospital admissions or exacerbations)

You may not qualify if:

• presence of severe psychiatric, neurologic or musculoskeletal conditions and/or unstable cardiovascular disease
• participation in regular exercise prior to the study

Sponsors & Collaborators

• Aveiro University: lead

Related Publications (1)

• Cruz J, Brooks D, Marques A. Impact of feedback on physical activity levels of individuals with chronic obstructive pulmonary disease during pulmonary rehabilitation: A feasibility study. Chron Respir Dis. 2014 Nov;11(4):191-8. doi: 10.1177/1479972314552280. Epub 2014 Oct 2.

  PMID: 25278009 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Alda S. Marques, PhD

  Aveiro University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 1, 2016
• Study Start: February 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 1, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share