NCT02122614

Brief Summary

The aim of this randomized controlled trial is to investigate the effects of adding PA monitoring and regular feedback of a pedometer (step counter) to an outpatient pulmonary rehabilitation (PR) program on daily PA levels and health status of patients with COPD. Patients will be randomized to either receive a PR program with PA monitoring and regular feedback of a pedometer (experimental group \[EG\]) or a PR program alone (control group \[CG\]). During the PR program, patients in the EG will receive a pedometer to self-monitor their PA and individualized step-count goals. They will continue to use the pedometers and receive individualized goals for 3 months after the program. It is expected that, by receiving individualized goals and a simple pedometer to self-monitor their PA during and after a PR program, patients with COPD will become more active and adhere to long-term rehabilitation, thus reducing the overall impact of COPD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 15, 2015

Status Verified

January 1, 2015

Enrollment Period

9 months

First QC Date

April 23, 2014

Last Update Submit

April 14, 2015

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic obstructive pulmonary diseaseCOPDPulmonary rehabilitationPhysical activityExercise

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.

    1 week before, 1 week after, 3 and 6 months after the PR program

Secondary Outcomes (7)

  • Change in exercise tolerance

    1 week before, 1 week after, 3 and 6 months after the PR program

  • Change in peripheral muscle strength

    1 week before, 1 week after, 3 and 6 months after the PR program

  • Change in activities limitation resulting from breathlessness

    1 week before, 1 week after, 3 and 6 months after the PR program

  • Change in behavioral regulations in exercise

    1 week before, 1 week after, 3 and 6 months after the PR program

  • Change in general self-efficacy

    1 week before, 1 week after, 3 and 6 months after the PR program

  • +2 more secondary outcomes

Other Outcomes (2)

  • Change in lung function

    1 week before, 1 week after, 3 and 6 months after the PR program

  • Change in the number and duration of respiratory exacerbations and hospitalizations

    1 week before, 1 week after, 3 and 6 months after the PR program

Study Arms (2)

Experimental group

EXPERIMENTAL
Behavioral: Pulmonary rehabilitation (PR) plus PA monitoring and feedback from a pedometer

Control group

ACTIVE COMPARATOR
Behavioral: Pulmonary rehabilitation (PR)

Interventions

Pulmonary rehabilitation (PR) plus PA monitoring and feedback from a pedometerBEHAVIORAL

Patients will enrol in a 12-week PR program comprising exercise training (3 times per week) and psychoeducation sessions (once a week). Patients will also receive a pedometer to self-monitor their PA during and after the PR program and individualized step-count goals.

Experimental group
Pulmonary rehabilitation (PR)BEHAVIORAL

Patients will enrol in a 12-week PR program comprising exercise training (3 times per week) and psychoeducation sessions (once a week).

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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)
  • able to provide their own informed consent

You may not qualify if:

  • inability to understand and co-operate
  • presence of severe psychiatric conditions
  • presence of severe neurologic/ musculoskeletal conditions and/or unstable cardiovascular disease
  • participation in regular strenuous exercise (e.g., greater than 10 hours per week of running, swimming, weightlifting or any other similar physical activity) prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aveiro

Aveiro, Aveiro District, 3810-193, Portugal

Location

Related Publications (4)

  • Cruz J, Brooks D, Marques A. Home telemonitoring in COPD: a systematic review of methodologies and patients' adherence. Int J Med Inform. 2014 Apr;83(4):249-63. doi: 10.1016/j.ijmedinf.2014.01.008. Epub 2014 Jan 23.

    PMID: 24529402BACKGROUND

  • Cruz J, Brooks D, Marques A. Home telemonitoring effectiveness in COPD: a systematic review. Int J Clin Pract. 2014 Mar;68(3):369-78. doi: 10.1111/ijcp.12345. Epub 2014 Jan 28.

    PMID: 24472009BACKGROUND

  • 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: 25278009BACKGROUND

  • Cruz J, Brooks D, Marques A. Walk2Bactive: A randomised controlled trial of a physical activity-focused behavioural intervention beyond pulmonary rehabilitation in chronic obstructive pulmonary disease. Chron Respir Dis. 2016 Feb;13(1):57-66. doi: 10.1177/1479972315619574. Epub 2015 Dec 23.

    PMID: 26703921DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Alda S. Marques, PhD

    School of Health Sciences of the University of Aveiro (ESSUA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

April 23, 2014

First Posted

April 24, 2014

Study Start

April 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 15, 2015

Record last verified: 2015-01

Locations

PT(1)