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Physical Activity Versus Pulmonary Rehabilitation in COPD (LIVELY)

U

Ulster University

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Behavioral: Pulmonary Rehabilitation Programme
Behavioral: Physical Activity Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02161393
WT12/20

Details and patient eligibility

About

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.

Full description

A survey of pulmonary rehabilitation programmes mirrored the results of other UK studies and highlighted that there are not enough programmes available; currently in the UK less than 1.5% of patients with COPD receive pulmonary rehabilitation per year. Only a proportion of patients are targeted i.e. those with moderate to severe disease. The majority of programmes are outpatient-based and are supervised by clinicians. This structured and supervised format of pulmonary rehabilitation does not meet the needs of all patients with high numbers of dropouts and non-adherence; yet alternative options for increasing physical activity for patients with COPD currently do not seem to be offered.

A home-based pedometer-driven walking intervention offers an alternative method of delivering physical activity training that could be provided to larger numbers of patients, at a lower cost and with flexibility around life commitments. It would also provide patients with more choice when deciding whether to participate in exercise or physical activity.

To date no study has compared a home-based walking intervention to structured, supervised pulmonary rehabilitation or the patient preferences or cost of the two programmes. For this reason, there is a need to compare a home-based-walking intervention to the standard method of providing patients with physical activity training, i.e. pulmonary rehabilitation. Therefore this study is essential as it will assess the feasibility of conducting a trial to investigate the efficacy of a physical activity intervention (physical activity consultation and a pedometer-based walking programme) versus pulmonary rehabilitation in improving physical activity in COPD.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. The Patient must be referred to pulmonary rehabilitation.
  2. The Patient must have a Primary diagnosis of COPD
  3. The Patient must have a good understanding of written English (as reported by the individual patient)
  4. 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.

Exclusion criteria

  1. 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)
  2. The inability to comprehend or follow instructions (e.g. dementia).
  3. Clinically unstable (Pulmonary exacerbation or any change in symptoms and medication in the last 4 weeks)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Physical Activity Intervention
Experimental group
Description:
12 week home-based walking programme consisting of weekly physical activity consultations and a pedometer-driven walking programme
Treatment:
Behavioral: Physical Activity Intervention
Pulmonary Rehabilitation Programme
Active Comparator group
Description:
6-week supervised outpatient programme consisting of twice-weekly exercise sessions and once-weekly education sessions.
Treatment:
Behavioral: Pulmonary Rehabilitation Programme

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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