Clinical trial NCT02725931: Impact of Feedback on Physical Activity and Health-related Outcomes During Pulmonary Rehabilitation in COPD
Official title: Impact of Feedback on Physical Activity Levels and Health-related Outcomes of Patients With COPD During Pulmonary Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic obstructive pulmonary disease
COPD
Pulmonary rehabilitation
Physical activity
Exercise
Lead sponsor: Aveiro University
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Change in physical activity levels
timeFrame: weeks 1, 7 and 12
Secondary outcomes:
measure: Change in exercise capacity
timeFrame: immediately before (week 1) and after (week 12) the PR program
measure: Change in peripheral muscle strength
timeFrame: immediately before (week 1) and after (week 12) the PR program
measure: Change in activities limitation resulting from breathlessness
timeFrame: immediately before (week 1) and after (week 12) the PR program
measure: Change in functional balance
timeFrame: immediately before (week 1) and after (week 12) the PR program
measure: Change in health-related quality of life
timeFrame: immediately before (week 1) and after (week 12) the PR program
measure: Patients' perspectives about the intervention
timeFrame: Immediately after the PR program (week 12)
Other outcomes:
Locations:
Study officials:
affiliation: Aveiro University
name: Alda S. Marques, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.