Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Physical Activity Versus Pulmonary Rehabilitation in COPD (LIVELY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02161393
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : August 25, 2017
Sponsor:
Collaborators:
Belfast Health and Social Care Trust
Western Health and Social Care Trust
Queen's University, Belfast
KU Leuven
Information provided by (Responsible Party):
Brenda O'Neill, University of Ulster

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Behavioral: Physical Activity Intervention Behavioral: Pulmonary Rehabilitation Programme Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PhysicaL actIvity interVention vErsus puLmonarY Rehabilitation in COPD: The LIVELY COPD Project.
Actual Study Start Date : February 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 19, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical Activity Intervention
12 week home-based walking programme consisting of weekly physical activity consultations and a pedometer-driven walking programme
Behavioral: Physical Activity Intervention
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.

Active Comparator: Pulmonary Rehabilitation Programme
6-week supervised outpatient programme consisting of twice-weekly exercise sessions and once-weekly education sessions.
Behavioral: Pulmonary Rehabilitation Programme
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.




Primary Outcome Measures :
  1. Change from baseline in physical activity will be assessed using step counts recorded with an Actigraph activity monitor. [ Time Frame: Baseline and at 6-weeks for PR group and 12-weeks for PA group ]
    The activity monitor is worn for 7 consecutive full days prior to the intervention, and 7 full days immediately after the intervention.


Secondary Outcome Measures :
  1. Change from baseline in time spent in physical activity and in sitting using the International Physical Activity Questionnaire [ Time Frame: 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 ]
  2. Change from baseline in exercise Capacity using the Incremental Shuttle Walk Test [ Time Frame: 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 ]
  3. Change from baseline in Quality of Life using the EuroQOL-5D [ Time Frame: 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 ]
  4. Change from baseline in Quality of Life using the COPD Assessment Test [ Time Frame: 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 ]
  5. Stage of change in terms of physical activity using the Stages of Change Questionnaire [ Time Frame: 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 ]
    The Stages of Change Questionnaire is the temporal part of the transtheoretical model. It will be used to determine the current stage of change the participant is at in terms of their physical activity behaviour.

  6. Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire [ Time Frame: 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 ]
    Marcus's Self-Efficacy Questionnaire is a component of the transtheoretical model which will provide more detailed information on each individual's confidence to undertake physical activity in different situations.

  7. Patients' perceptions of both interventions will be obtained via semi-structured interviews. [ Time Frame: At 6-weeks for PR group and 12-weeks for PA group ]
    Information will be collected with regards patient satisfaction with their exercise/activity, information regarding ease of execution, safety and tolerability of the programmes and the outcome measures, views about continuing exercise and suggestions for improving the programmes.

  8. Feasibility of the interventions [ Time Frame: End of study ]
    For both interventions information will be collected on recruitment and retention, dropouts, adherence and adverse events which will be necessary to establish feasibility.

  9. Global Rating of Change Questionnaire [ Time Frame: 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 ]
    This is a numerical rating scale about their patient's perception of any change in their physical activity

  10. Physical activity will be assessed using step counts recorded with an Actigraph activity monitor. [ Time Frame: At 18 (PR group) and 24 (PA group) weeks post randomisation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161393


Locations
Layout table for location information
United Kingdom
Belfast Health and Social Care Trust
Belfast, Co Antrim, United Kingdom, BT9 7AB
Western Health and Social Care Trust
Enniskillen, United Kingdom
Sponsors and Collaborators
University of Ulster
Belfast Health and Social Care Trust
Western Health and Social Care Trust
Queen's University, Belfast
KU Leuven
Investigators
Layout table for investigator information
Principal Investigator: Brenda O'Neill, PhD University of Ulster
Layout table for additonal information
Responsible Party: Brenda O'Neill, Senior Lecturer in Physiotherapy, University of Ulster
ClinicalTrials.gov Identifier: NCT02161393    
Other Study ID Numbers: WT12/20
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Keywords provided by Brenda O'Neill, University of Ulster:
Physical Activity
Pulmonary Rehabilitation
Chronic obstructive pulmonary disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases