Effects of a long-term home-based exercise training programme using minimal equipment vs. usual care in COPD patients: a study protocol for two multicentre randomised controlled trials (HOMEX-1 and HOMEX-2 trials)
Autor: | Julia Braun, Ramona M. Müller, Kaba Dalla Lana, Milo A. Puhan, Thomas Radtke, Anja Frei |
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Přispěvatelé: | University of Zurich, Frei, Anja |
Rok vydání: | 2019 |
Předmět: |
Quality of life
Pulmonary and Respiratory Medicine medicine.medical_specialty Minimal equipment Cost-Benefit Analysis medicine.medical_treatment 610 Medicine & health Walk Test Home-based law.invention Sports Equipment Study Protocol Pulmonary Disease Chronic Obstructive Exercise training intervention Functional exercise capacity 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Surveys and Questionnaires Intervention (counseling) Health care medicine Humans COPD Pulmonary rehabilitation 030212 general & internal medicine Exercise Randomized Controlled Trials as Topic Randomised controlled trial lcsh:RC705-779 Protocol (science) Physical activity business.industry 10060 Epidemiology Biostatistics and Prevention Institute (EBPI) lcsh:Diseases of the respiratory system medicine.disease Self Efficacy Exercise Therapy Self Care Dyspnea 030228 respiratory system 2740 Pulmonary and Respiratory Medicine Usual care Physical therapy business Switzerland |
Zdroj: | BMC Pulmonary Medicine, Vol 19, Iss 1, Pp 1-11 (2019) BMC Pulmonary Medicine |
ISSN: | 1471-2466 |
DOI: | 10.1186/s12890-019-0817-7 |
Popis: | Exercise training is an important component of pulmonary rehabilitation (PR) programmes in chronic obstructive pulmonary disease (COPD), but the great majority of COPD patients who would benefit from PR never follow such programmes or fail to maintain exercise training after PR completion. Against this background, we developed an exercise training programme that requires minimal equipment and can be implemented long-term in the patient’s home-setting. The aims of the HOMEX-1 and HOMEX-2 trials are to assess the effectiveness of this home-based exercise training programme in two groups of COPD patients over the course of one year: patients who have completed PR (HOMEX-1 trial) and patients who did not enrol in existing PR programmes within the last two years (HOMEX-2 trial). HOMEX-1 and HOMEX-2 are multicentre, parallel group, randomised controlled trials. For both trials each, it is planned to include 120 study participants with a diagnosis of COPD. Participants will be randomised with a 1:1 ratio into the intervention group or the control group (usual care/no intervention). The intervention consists of minimal-equipment exercise training elements with progressive level of intensity, conducted by the participant during six days per week and instructed and coached by a trained health care professional during three home visits and regular telephone calls during one year. Primary outcome is change in dyspnoea (domain of Chronic Respiratory Questionnaire) from baseline to 12-months follow-up. Secondary outcomes are change in dyspnoea over the course of the year (assessed at 3, 6 and 12 month) and change in functional exercise capacity, physical activity, health-related quality of life, health status, exacerbations and symptoms from baseline to 12 months follow-up. In addition, explanatory, safety and cost-effectiveness outcomes will be assessed. We will conduct intention-to-treat analyses separately per trial and per protocol analyses as sensitivity analyses. The HOMEX-1 and HOMEX-2 trials assess a novel intervention that provides an innovative way of making exercise training as accessible as possible for COPD patients. If the intervention proves to be effective long-term, it will fill the gap of providing an easily accessible and feasible intervention so that more COPD patients can follow an exercise programme. ClinicalTrials.gov Identifier: HOMEX-1 NCT03461887 (registration date: March 12, 2018; retrospectively registered); HOMEX-2 NCT03654092 (registration date: August 31, 2018). |
Databáze: | OpenAIRE |
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