Effects of Treadmill Versus Cycling Endurance Training in Patients With COPD

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: treadmill endurance training; Other: cycling endurance training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schoenau Am Koenigssee, Germany, 83471
    • Schoen Klinik Berchtesgadener Land

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: treadmill endurance training	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.
Active Comparator: cycling endurance training	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Schön Klinik Berchtesgadener Land

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Actual): November 27, 2017
• Study Completion (Actual): November 27, 2017

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: exercise; COPD; walking; pulmonary rehabilitation; training; cycling; treadmill
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: treadmill vs. cycling in COPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No