- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06471439
An Investigation of Different Type Single Limb Exercise Training Effects in Copd (COPD)
An Investigation of Different Type Single Limb Exercise Training Effects on Functional Capacity, Arterial Stifness, Muscle Activation and Quality of Life in Chronic Obstructive Pulmonary Disease
COPD presents not only respiratory symtoms but also vascular or muscle dysfunction. Exercise limitation is observed in COPD. Especially, decreased exercise performance related to vascular and fatique in quadriceps muscle. Exercise training is important for aerobic performance increasing. Generally results show exercise training with both lower limb. Increaed arterial stiffness and fatigue are observed in COPD. One leg exercise training result is not enough to highlight these parameters.
Three types single leg exercise intervantion will be applied. Exercise capacity, muscle strength, lung function, electromyography, lactate and quality of life will be measured.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Three types single leg exercise intervantion will applied to COPD patients that devided three groups. One leg continuous exercise training will be aplied to one group. One leg HIIT exercise training will be aplied to other group. One leg resistance exercise training will be aplied to the last group.
Exercise capacity and muscle strength are assesed. Lung function is measured. Electormyography is recorded. Lactate and quality of life are measured.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: elif kocaaga, Ms
- Phone Number: +903123052525
- Email: elifkocaaga86@gmail.com
Study Contact Backup
- Name: elif kocaaga, Ms
- Phone Number: +903123052525
- Email: elifkocaaga86@hotmail.com
Study Locations
-
-
-
Ankara, Turkey
- Recruiting
- Elif Kocaaga
-
Contact:
- elif kocaaga, Ms
- Phone Number: +903123052525
- Email: elifkocaaga86@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- COPD patients that applied to physiotherapy
- Cooperation for tests
- without severe ortopedical and neurological disease
- without severe cardiovascular disease
- To volunteer for the study.
Exclusion Criteria:
- have an acute exacerbation or having exacerbation at last month
- hypoxemia (PaO2<55mmHg)
- no cooperated to test without volunteer to study having ortophedical and neurological diesase that affecting of tests severe cardiovascular disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: single leg resistance exercise intervantion in COPD
single leg resistance exercise intervantion in COPD will be perfomed at six weeks
|
single leg exercise intervantions
Other Names:
|
|
Active Comparator: single leg continous exercise intervantion in COPD
single leg continous exercise intervantion in COPD will be perfomed at six weeks
|
single leg exercise intervantions
Other Names:
|
|
Active Comparator: single leg high intensity exercise intervantion in COPD
single leg high intensity exercise intervantion in COPD will be perfomed at six weeks
|
single leg exercise intervantions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
six minute walk test
Time Frame: pre-intervention
|
six minute walk test in meter
|
pre-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cardiopulmonary exercise test
Time Frame: beginning day 2
|
VO2 as ml/kg/min will be recorded from incremental cycle cpet test
|
beginning day 2
|
|
one leg cardiopulmonary exercise test
Time Frame: beginning, day 3
|
VO2 as ml/kg/min will be recorded from incremental cycle cpet test
|
beginning, day 3
|
|
quadriceps muscle strength assesing (repeated measeure)
Time Frame: beginning day 1 and last day
|
quadriceps muscle 10 repeated max muscle strength will be recorded at kilogram,
|
beginning day 1 and last day
|
|
isometrics quadriceps muscle strength assesing
Time Frame: beginning day 1 and last day
|
quadriceps muscle isometric muscle strength will be recorded at kilogram
|
beginning day 1 and last day
|
|
lung function
Time Frame: beginning day 1 and last day
|
FEV1/FVC ratio in %
|
beginning day 1 and last day
|
|
quality of life assesing
Time Frame: beginning day 1 and last day
|
total score in 0-100 range
|
beginning day 1 and last day
|
|
arterial stiffness
Time Frame: beginning day 2 and last day
|
total vascular resitance, augmentation index @ 75 and pulse wave velocity wil be determined arterial stiffness
|
beginning day 2 and last day
|
|
lactate measurement
Time Frame: beginning day 2 and last day
|
lactate in mmol
|
beginning day 2 and last day
|
|
electromyography measurement
Time Frame: beginning day 2 and last day
|
precentage of maximum volunteer contraction) %MVC values will be presented muscle fatigue (median frequence) and activation will be shown electromyograpy (EMG)
|
beginning day 2 and last day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: elif kocaaga, ms, Hacettepe University
Publications and helpful links
General Publications
- Evans RA, Dolmage TE, Mangovski-Alzamora S, Romano J, O'Brien L, Brooks D, Goldstein RS. One-Legged Cycle Training for Chronic Obstructive Pulmonary Disease. A Pragmatic Study of Implementation to Pulmonary Rehabilitation. Ann Am Thorac Soc. 2015 Oct;12(10):1490-7. doi: 10.1513/AnnalsATS.201504-231OC.
- Dolmage TE, Goldstein RS. Effects of one-legged exercise training of patients with COPD. Chest. 2008 Feb;133(2):370-6. doi: 10.1378/chest.07-1423. Epub 2007 Oct 9.
- MacInnis MJ, Morris N, Sonne MW, Zuniga AF, Keir PJ, Potvin JR, Gibala MJ. Physiological responses to incremental, interval, and continuous counterweighted single-leg and double-leg cycling at the same relative intensities. Eur J Appl Physiol. 2017 Jul;117(7):1423-1435. doi: 10.1007/s00421-017-3635-8. Epub 2017 May 11.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KA-22104
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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