ExerciseCOPDNCT06471439
An Investigation of Different Type Single Limb Exercise Training Effects in Copd
A study testing single leg exercise intervantion in COPD in people with Exercise, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Exercise
- What is being tested?
- single leg exercise intervantion in COPD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jun 2023to 2 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients that applied to physiotherapy
- Cooperation for tests
- without severe ortopedical and neurological disease
- without severe cardiovascular disease
- To volunteer for the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Elif Kocaaga
Ankara
elif kocaaga, Ms, +903123052525, elifkocaaga86@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Exercise
- Being tested
- single leg exercise intervantion in COPD
- Keywords
- Chronic Obstructive Pulmonary Disease, Single Limb exercise, resistance training, continous exercise training, high intensity exercise training
- Medical subject headings
- Motor Activity, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single leg exercise intervantion in COPDOther
Also called single leg exercise intervantion
single leg exercise intervantions
- high intensity interval training
- continous exercise training
- resistance exercise training
| Study group | Role | What they receive |
|---|---|---|
| single leg resistance exercise intervantion in COPD | Active comparator | single leg resistance exercise intervantion in COPD will be perfomed at six weeks Receives: Other: single leg exercise intervantion in COPD |
| single leg continous exercise intervantion in COPD | Active comparator | single leg continous exercise intervantion in COPD will be perfomed at six weeks Receives: Other: single leg exercise intervantion in COPD |
| single leg high intensity exercise intervantion in COPD | Active comparator | single leg high intensity exercise intervantion in COPD will be perfomed at six weeks Receives: Other: single leg exercise intervantion in COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
six minute walk test
six minute walk test in meter
Measured: pre-intervention
Secondary outcomes (9)
cardiopulmonary exercise test
VO2 as ml/kg/min will be recorded from incremental cycle cpet test
Measured: beginning day 2
one leg cardiopulmonary exercise test
VO2 as ml/kg/min will be recorded from incremental cycle cpet test
Measured: beginning, day 3
quadriceps muscle strength assesing (repeated measeure)
quadriceps muscle 10 repeated max muscle strength will be recorded at kilogram,
Measured: beginning day 1 and last day
isometrics quadriceps muscle strength assesing
quadriceps muscle isometric muscle strength will be recorded at kilogram
Measured: beginning day 1 and last day
lung function
FEV1/FVC ratio in %
Measured: beginning day 1 and last day
quality of life assesing
total score in 0-100 range
Measured: beginning day 1 and last day
arterial stiffness
total vascular resitance, augmentation index @ 75 and pulse wave velocity wil be determined arterial stiffness
Measured: beginning day 2 and last day
lactate measurement
lactate in mmol
Measured: beginning day 2 and last day
electromyography measurement
precentage of maximum volunteer contraction) %MVC values will be presented muscle fatigue (median frequence) and activation will be shown electromyograpy (EMG)
Measured: beginning day 2 and last day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start16 Jun 2023
- Primary completion2 Jan 2025 (estimated)
- Study completion2 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- three different type one leg exercise intervention are apllied in patients with copd
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Kocaaga, Hacettepe University
- Investigators
- elif kocaaga, ms, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471439
- Sponsor's protocol ID
- KA-22104
- Acronym
- COPD
- Status last verified
- Jun 2024
- First submitted
- 17 May 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17925417Evans 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.
PubMed 26291542MacInnis 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.
PubMed 28497384
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06471439
- Acronym / sponsor ID
- COPD / KA-22104
- Conditions
- Exercise
- Keywords
- Chronic Obstructive Pulmonary Disease, Single Limb exercise, resistance training, continous exercise training, high intensity exercise training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 2 Jan 2025 (estimated)
- Study completion
- 2 Jan 2025 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- three different type one leg exercise intervention are apllied in patients with copd
| Arm | Type | Receives |
|---|---|---|
| single leg resistance exercise intervantion in COPD | Active comparator | Other: single leg exercise intervantion in COPDsingle leg resistance exercise intervantion in COPD will be perfomed at six weeks |
| single leg continous exercise intervantion in COPD | Active comparator | Other: single leg exercise intervantion in COPDsingle leg continous exercise intervantion in COPD will be perfomed at six weeks |
| single leg high intensity exercise intervantion in COPD | Active comparator | Other: single leg exercise intervantion in COPDsingle leg high intensity exercise intervantion in COPD will be perfomed at six weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD patients that applied to physiotherapy
- Cooperation for tests
- without severe ortopedical and neurological disease
- without severe cardiovascular disease
- To volunteer for the study.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single leg exercise intervantion in COPDAlso: single leg exercise intervantionsingle leg exercise intervantions 1. high intensity interval training 2. continous exercise training 3. resistance exercise training | Other | single leg continous exercise intervantion in COPD, single leg high intensity exercise intervantion in COPD, single leg resistance exercise intervantion in COPD |
Primary outcome
six minute walk test
Time frame: pre-intervention
six minute walk test in meter
9 secondary outcomes
cardiopulmonary exercise test
Time frame: beginning day 2
one leg cardiopulmonary exercise test
Time frame: beginning, day 3
quadriceps muscle strength assesing (repeated measeure)
Time frame: beginning day 1 and last day
isometrics quadriceps muscle strength assesing
Time frame: beginning day 1 and last day
lung function
Time frame: beginning day 1 and last day
quality of life assesing
Time frame: beginning day 1 and last day
arterial stiffness
Time frame: beginning day 2 and last day
lactate measurement
Time frame: beginning day 2 and last day
electromyography measurement
Time frame: beginning day 2 and last day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Background: PubMed 17925417Dolmage 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.
- Background: PubMed 26291542Evans 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.
- Background: PubMed 28497384MacInnis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
elif kocaaga, ms principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single leg exercise intervantion in COPD in people with Exercise, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact elif kocaaga, Ms (+903123052525, elifkocaaga86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
six minute walk test (time frame: pre-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06471439, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.