Outdoor walking training versus cycle ergometer training during inpatient rehabilitation in COPD patients GOLD stages III to IV. A feasibility randomized controlled trial

Not Applicable

• Conditions: COPD GOLD stage III und IV; J44; Other chronic obstructive pulmonary disease

• Registration Number: DRKS00010977
• Lead Sponsor: Kliniken Valens, Rehazentrum Valens

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-21
• Study Completion: 2017-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

We intend to include patients with stable COPD GOLD III to IV (no acute exacerbation) during 3 weeks inpatient rehabilitation. Main inclusion criteria are the ability to walk 150m, the ability to ride a cycle ergometer (25 Watt) and to speak/read German.

Exclusion Criteria

Main exclusion criteria are physically limiting musculoskeletal, cardial disease and uncontrolled Hypertension, which make participation impossible.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome, the feasibility of outdoor walking training in severe COPD patients and the study design, will be measured during the whole study.<br>The feasibility factors are measured by reasons for exclusion (counting), recruitment rate (counting), reasons for drop outs (interview), follow up rate (counting), Patients and physiotherapists satisfaction (questionnaire), intensity of the training method (evaluation of the training protocol, especially the heartbeat frequency), missing data (training protocol), estimate sample size for a future study (calculating with Gpower 3.1). <br>

Secondary Outcome Measures

Name	Time	Method
Main secondary outcomes are the health-related quality of life, measured by the chronic respiratory questionnaire (CRQ) and physical capacity, measured by the six minute walking test (6MWT). The patients receive the CRQ at admission, after 3 weeks and 3 month follow up. The physical capacity will be measured with the 6MWT at admission and after 3 weeks. <br>We like to investigate the minimal important difference of the 6MWT and whether the different groups achieve a different cut off. Therefore we check the protocol of the 6MWT.The physical activity will be investigated with an activity tracker (Fitbit one). The patients will wear it 5 day in the last week in the rehabilitation and other 5 days after 3 month follow up (send it at home with an envelope for sending it back). To investigate the frequency of exacerbation, we will assessed it by telephone interview after 3 month follow up.