Effects of Treadmill Versus Cycling Endurance Training in Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effects of a Three Week Treadmill Versus Cycling Endurance Training on Balance, Gait Performance and Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120169
• Other study ID #: treadmill vs. cycling in COPD
• Status: Completed
• Phase: N/A
• First received: April 13, 2017
• Last updated: February 14, 2018
• Start date: March 30, 2017
• Est. completion date: November 27, 2017

Study information

• Verified date: February 2018
• Source: Klinikum Berchtesgadener Land der Schön-Kliniken
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of this study is to investigate the effects of treadmill versus cycling endurance training on Balance, gait performance and exercise capacity in patients with severe chronic obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized into one of two intervention groups. Walking intensity in the treadmill group will be set at 80 percent of the average speed of the 6-minute walking test. The cycling group will exercise at an intensity of 60 percent according to an Initial incremental cycling test.

Patients will perform 5 to 6 training sessions per week. The total exercise duration will be progressively increased from 10 to 30 minutes. Walking or cycling intensity will also be progressively increased if perceived exertion during exercise is rated below 3 on the modified 10-point Borg scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 27, 2017
• Est. primary completion date: November 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• COPD Stage III or IV according to the global initiative for chronic obstructive lung disease

• impaired exercise capacity (6 Minute walk distance of less than 70% of the reference values from Troosters et al.)

Exclusion Criteria:

• acute, severe exacerbation of COPD

• carbon dioxide of more than 45 mmHg at rest

• any disabilities that prevent patient form walking or cycling

• Patient is not able to walk 20 meters without any aid (for example rollator)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• treadmill endurance training
n = 15 patients with COPD. Walking intensity will be initially set at 80 percent of 6-minute Walking test Speed with progressive increase in Duration and intensity.
• cycling endurance training
n=15 patients with COPD. Cycling intensity will initially be set at 60 percent of Peak work rate with progressive increase in Duration and intensity

Locations

Country	Name	City	State
Germany	Schoen Klinik Berchtesgadener Land	Schoenau Am Koenigssee

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	Change in step symmetry during 20m walking	Patients walk 20m while wearing the Mc Roberts move test device (triaxial accelerometer) which performs a gait analysis	measurement on day 1 and 21
Secondary	Change in balance performance during semi-tandem stance	patients stand still for 10 seconds on a force platform that measures absolute path length of the center of force.	measurement on day 1 and 21
Secondary	Change in balance performance during Romberg stance	patients stand still for 10 seconds on a force platform that measures absolute path length of the center of force.	measurement on day 1 and 21
Secondary	Change in balance performance during single leg stance	patients stand still for 10 seconds on a force platform that measures absolute path length of the center of force.	measurement on day 1 and 21
Secondary	Change in muscle power during counter movement jump	patients jump on a force platform as high as possible. The Outcome is Watt per Kilogram Body weight	measurement on day 1 and 21
Secondary	Change in 1 Minute sit to stand test	Patients try to perform as many repetitions as possible of standing up and sitting down from a chair with crossed arms on a force platform during 1 minute	measurement on day 1 and 21
Secondary	Change in 5 Repetition sit to stand test	Patients try to perform 5 repetitions of standing up and sitting down from a chair with crossed arms on a force platform as quick as possible	measurement on day 1 and 21
Secondary	Change in peak muscle strength	isometric peak torque of the knee extensor muscles are measured in 90° knee angle	measurement on day 1 and 21
Secondary	Change in 4 meter gait Speed test	patients have to walk 4 meters at their usual Speed. Outcome is the average Speed during the 4m walk.	measurement on day 1 and 21
Secondary	Change in 6-minute Walk test	the best out of two 6- Minute Walk Tests will be used for analysis	measurement on day 1 and 21
Secondary	Change in Hospital anxiety and Depression scale	the Hospital anxiety and Depression scale is a questionnaire that evaluates signs of anxiety or depression	measurement on day 1 and 21