NCT03120169

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2017

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

April 13, 2017

Last Update Submit

February 14, 2018

Conditions

Keywords

COPDexercisetrainingcyclingtreadmillwalkingpulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Change in balance performance during semi-tandem stance

    measurement on day 1 and 21

  • Change in balance performance during Romberg stance

    measurement on day 1 and 21

  • Change in balance performance during single leg stance

    measurement on day 1 and 21

  • Change in muscle power during counter movement jump

    measurement on day 1 and 21

  • Change in 1 Minute sit to stand test

    measurement on day 1 and 21

  • +5 more secondary outcomes

Study Arms (2)

treadmill endurance training

ACTIVE COMPARATOR
Other: treadmill endurance training

cycling endurance training

ACTIVE COMPARATOR
Other: cycling endurance training

Interventions

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.

treadmill 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

cycling endurance training

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schoen Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head physican (department of pneumology)

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 19, 2017

Study Start

March 30, 2017

Primary Completion

November 27, 2017

Study Completion

November 27, 2017

Last Updated

February 15, 2018

Record last verified: 2018-02

Locations