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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02209207
Other study ID # Walking trial 2014
Secondary ID
Status Completed
Phase N/A
First received July 31, 2014
Last updated February 23, 2016
Start date July 2014
Est. completion date November 2015

Study information

Verified date February 2016
Source Klinikum Berchtesgadener Land der Schön-Kliniken
Contact n/a
Is FDA regulated No
Health authority Germany: ethic commissions
Study type Interventional

Clinical Trial Summary

This study will investigate the effects of interval walking training versus continuous walking training in patients with chronic obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized to one of the two intervention groups. All walking training sessions will be performed on the same treadmill. Walking intensity in the continuous walking group will be 60 percent of the average speed of the 6-minute walking test. Patients in the interval training group will perform high intensity intervals at 120% of the 6-minute walking test speed for 60 seconds alternating with 60 seconds of rest. The total exercise duration will be progressively increased from 10 to 32 minutes.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- COPD stage III or IV according to the Global Initiative for chronic obstructive lung disease [GOLD]

- stationary patient in the Schön Klinik Berchtesgadener Land

Exclusion Criteria:

- acute, severe exacerbation of COPD

- failure to comply with study process

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Treadmill

Other:
walking training


Locations

Country Name City State
Germany Schön Klinik Berchtesgadener Land Schönau am Königssee

Sponsors (1)

Lead Sponsor Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary perceived exertion for dyspnea during walking training measured via modified Borg scale (0 to 10) day 1 to 21 No
Secondary heart rate during walking training day 1 to 21 No
Secondary perceived exertion for leg fatigue (Borg-scale) during three weeks of rehabilitation No
Secondary Oxygen saturation during walking training measured via pulse oximeter day 1 to 21 No
Secondary fat free mass in kilogram measured via Bioimpedance Analysis day 1 to 21 No
Secondary forced expiratory volume in 1 second (FEV1) in liter measured by spirometry day 1 to 21 No
Secondary Sit-to-stand-test 5 repetitions of standing up and sitting down from a chair with crossed arms as quick as possible day 1 to 21 No
Secondary 6-minute walking test the best 6-minute walking test out of two tests on admission and at discharge will be taken day 1 to 21 No
Secondary 36 item short-form health Survey (SF-36) questionnaire for disease unspecific quality of life day 1 to 21 No
Secondary chronic respiratory questionnaire (CRQ) disease specific quality of life questionnaire day 1 to 21 No
Secondary hospital anxiety and depression scale (HADS) questionnaire on symptoms of anxiety and depression day 1 to 21 No
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