Physical Activity Versus Pulmonary Rehabilitation in COPD

NCT02161393 | Completed DMC

• 1 other identifier: WT12/20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The primary aim of this study is to assess the feasibility of conducting a trial to investigate the effectiveness of a physical activity intervention (physical activity consultation and a pedometer-based walking programme) versus pulmonary rehabilitation in improving physical activity in COPD. Objectives are: (i) to assess the feasibility (patient recruitment, adherence, drop-outs and adverse events) of delivering a physical activity intervention in the COPD patient population versus pulmonary rehabilitation; (ii) to explore users perceptions relating to satisfaction and benefits of a physical activity intervention versus pulmonary rehabilitation; (iii) to investigate between and within group change in physical activity, exercise capacity, quality of life, self-efficacy and changes in the transtheoretical model with the physical activity intervention versus pulmonary rehabilitation; and (iv) to examine the cost of delivering a physical activity intervention versus pulmonary rehabilitation for patients with COPD. The hypothesis for this study is that it will be feasible to conduct a trial that will investigate the effectiveness of a physical activity intervention (physical activity consultation and a pedometer-based walking programme) compared to pulmonary rehabilitation for improving physical activity in COPD. The study will provide important information about interventions designed to promote and maintain physical activity, improve patient outcomes and increase patients' choice relating to exercise and physical activity interventions. It will provide a rationale and data for an adequately powered clinical trial evaluating the effects of a physical activity intervention.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Physical Activity; Pulmonary Rehabilitation; Chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in physical activity will be assessed using step counts recorded with an Actigraph activity monitor.

  The activity monitor is worn for 7 consecutive full days prior to the intervention, and 7 full days immediately after the intervention.

  Baseline and at 6-weeks for PR group and 12-weeks for PA group

Secondary Outcomes (10)

• Change from baseline in time spent in physical activity and in sitting using the International Physical Activity Questionnaire

  Baseline and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation

• Change from baseline in exercise Capacity using the Incremental Shuttle Walk Test

  Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation

• Change from baseline in Quality of Life using the EuroQOL-5D

  Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation

• Change from baseline in Quality of Life using the COPD Assessment Test

  Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation

• Stage of change in terms of physical activity using the Stages of Change Questionnaire

  Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation

Study Arms (2)

Physical Activity Intervention

EXPERIMENTAL

12 week home-based walking programme consisting of weekly physical activity consultations and a pedometer-driven walking programme

Behavioral: Physical Activity Intervention

Pulmonary Rehabilitation Programme

ACTIVE COMPARATOR

6-week supervised outpatient programme consisting of twice-weekly exercise sessions and once-weekly education sessions.

Behavioral: Pulmonary Rehabilitation Programme

Interventions

Physical Activity Intervention BEHAVIORAL

The 12 week home-based pedometer-driven walking programme will consist of weekly physical activity consultations. Pedometers will be used to set weekly step goals and motivate patients. Patients will wear the pedometer for 7 days and will record their daily steps in a step diary. At the next appointment the step target for the subsequent week will be agreed between the physiotherapist/researcher and participant. Each week thereafter the physiotherapist/researcher and patient will discuss their progress, document their mean daily step count for the previous week, and agree to a new daily step target for the subsequent week. The walking programme will be tailored to the individual and progressed on a weekly basis.

Physical Activity Intervention

Pulmonary Rehabilitation Programme BEHAVIORAL

This will be a 6-week supervised outpatient programme. The exercise component will last for one hour and be delivered twice weekly. It will consist of cardiovascular exercises and lower and upper body strengthening exercises. Education sessions will be delivered once weekly. Each patient will be provided with a home exercise programme to complete unsupervised once weekly.

Pulmonary Rehabilitation Programme

Eligibility Criteria

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

You may qualify if:

• The Patient must be referred to pulmonary rehabilitation.
• The Patient must have a Primary diagnosis of COPD
• The Patient must have a good understanding of written English (as reported by the individual patient)
• The Patient must be in a stable phase (not on antibiotics at the time of assessment with the ISWT), and deemed clinically stable by the clinical pulmonary rehabilitation team.

You may not qualify if:

• The inability to safely take part in a walking programme or pulmonary rehabilitation (e.g. unstable angina, neurological, spinal or skeletal dysfunction affecting ability to exercise)
• The inability to comprehend or follow instructions (e.g. dementia).
• Clinically unstable (Pulmonary exacerbation or any change in symptoms and medication in the last 4 weeks)

Sponsors & Collaborators

• University of Ulster: lead
• Belfast Health and Social Care Trust: collaborator
• Western Health and Social Care Trust: collaborator
• Queen's University, Belfast: collaborator
• KU Leuven: collaborator

Study Sites (2)

Belfast Health and Social Care Trust

Belfast, Co Antrim, BT9 7AB, United Kingdom

Location

Western Health and Social Care Trust

Enniskillen, United Kingdom

Location

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

• Brenda O'Neill, PhD

  University of Ulster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Physiotherapy

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: June 11, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 19, 2016
• Last Updated: August 25, 2017

Record last verified: 2017-08

Locations

GB (2)