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

NCT ID: NCT02725931

Last Updated: 2016-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-08-31

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.

Detailed Description

Patients with Chronic Obstructive Pulmonary Disease (COPD) present lower levels of physical activity (PA), which have been associated with adverse outcomes including increased healthcare utilisation and reduced survival. Thus, improving PA levels has become one of the main goals of COPD research.

Pulmonary rehabilitation (PR) is a cornerstone of COPD management with well-documented effects on exercise capacity and quality of life. However, its effects in increasing patients' physical activity (PA) levels are limited. Previous research has suggested that PR with PA monitoring and feedback may be a suitable approach to increase and/or maintain patients' PA levels.

Patients with COPD will participate in a 12-week PR program plus a PA-focused intervention. Daily PA will be measured using activity monitors GT3X+ (ActiGraph, Pensacola, FL) on weeks (W) 1, 7 and 12 and feedback will be given to participants in the following weeks regarding: daily steps; time spent in sedentary, light and moderate-to-vigorous (MVPA) intensity activities.

The impact of the intervention will be explored using a mixed-methods approach.

Assessments will be conducted immediately before (W1) and after (W12) the PR program. Breathlessness, exercise capacity, functional balance, peripheral muscle strength and health-related quality of life will be assessed in both time points.

Descriptive statistics will be used to characterise the sample. To analyse changes in outcome measures, data from the two time points will be compared. Correlations between PA data and health-related outcomes will be performed at W1 and using the change scores (i.e., W12-W1).

Patients will also be invited to attend focus groups after the intervention to assess their perspectives about the use of activity monitors and the feedback given.

This is a pilot study which will inform the main study (including the sample size calculation).

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Activity group

Pulmonary rehabilitation plus physical activity intervention

Group Type: EXPERIMENTAL

Pulmonary rehabilitation (PR) plus PA-focused intervention

Intervention Type: 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.

Interventions

Pulmonary rehabilitation (PR) plus PA-focused intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aveiro University

OTHER

Sponsor Role: lead

Responsible Party

Alda Sofia Pires de Dias Marques

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alda S. Marques, PhD

Role: PRINCIPAL_INVESTIGATOR

Aveiro University

References

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.

Reference Type: RESULT

PMID: 25278009 (View on PubMed)

Other Identifiers

SFRH /BD/81328/2011

Identifier Type: -

Identifier Source: org_study_id