Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02161393
Study type Interventional
Source University of Ulster
Contact
Status Completed
Phase N/A
Start date February 2014
Completion date January 19, 2016

See also
  Status Clinical Trial Phase
Completed NCT03282019 - Study of Long-term HFNC for COPD Patients With HOT N/A
Completed NCT05573464 - A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With the Hydrofluoroolefin Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease Phase 3
Recruiting NCT06040086 - Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations Phase 3
Not yet recruiting NCT06376994 - Multi-Center Clean Air Randomized Controlled Trial in COPD Phase 3
Completed NCT02926534 - Cross-Sectional Study of COPD Prevalence Among Smokers, Ex-smokers and Never-Smokers in Almaty, Kazakhstan N/A
Completed NCT02728674 - Management of Patients With Respiratory Symptoms in Sweden N/A
Completed NCT02797392 - Feasibility of a Preventive Program Against Lifestyle Related Diseases N/A
Recruiting NCT02415478 - Bronchioscopic Lung Volume Reduction (BLVR) N/A
Completed NCT02518139 - A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT02774226 - Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT03487406 - Anti-platelet Therapy in the Prevention of Cardiovascular Disease in Patients With COPD (APPLE-COPD: ICON 2) Phase 2
Completed NCT02459080 - Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT02512510 - Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT01908140 - Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT01893476 - A Pragmatic Cluster Trial of a Tailored Intervention to Improve COPD Management N/A
Withdrawn NCT01908933 - Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema Phase 3
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Completed NCT01701869 - Microbiology & Immunology of the Chronically-inflamed Airway N/A
Recruiting NCT02527486 - Seoul National University Airway Registry N/A
Terminated NCT01388920 - Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting Phase 2