Pulmonary Disease, Chronic ObstructiveNCT06644898
The Effect of Gait Training Using Different Slope Types on Balance in COPD Patients
A study testing Level walking training, Downhill walking training and Uphill walking training in people with Pulmonary Disease, Chronic Obstructive, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Although COPD is basically a respiratory system disease, its effects are not limited to the respiratory system. In this context, one parameter affected in COPD patients is balance. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Level walking training, Downhill walking training and Uphill walking training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Apr 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Being diagnosed with COPD (A, B, E groups according to GOLD assessment)
- Ambulate on your own
- Not having any contraindications for exercise
Who cannot join
- Being in GOLD 4 stage in spirometric evaluation
- Presence of hypoxemia
- Participation in another pulmonary rehabilitation program within the last 6 months
- Having an exacerbation in the last 1 month
- Being diagnosed with additional respiratory disease (asthma, bronchiectasis, etc.)
- Having had pulmonary surgery
Show all 9Show fewer
- Having an orthopedic, neurological or cardiac disease that affects exercise
- Having uncontrolled hypertension or diabetes
- Presence of malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alis Kostanoğlu, Assoc. Prof. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University, Department of Physiotherapy and Rehabilitation
Istanbul, Eyüp Sultan
Alis Kostanoglu, +90 0543 493 1848, Akostanoglu@bezmialem.edu.tr
About this study
Official title: The Effect of Aerobic Exercise Training at Different Slope Types on Balance in COPD Patients
Although COPD is basically a respiratory system disease, its effects are not limited to the respiratory system. In this context, one parameter affected in COPD patients is balance. Recent studies have highlighted the importance of assessing balance and incorporating it into treatment options such as pulmonary rehabilitation. In this context, we aim to diversify the training by using different slope types (downhill, level, uphill) in aerobic exercise training, which is a strong component of pulmonary rehabilitation, and to evaluate the effect of slope type on balance. Testing different types of inclines in aerobic exercise training has the potential to result in different muscular gains. We anticipate that this may result in different balance gains.
Read the detailed description
The convenience sampling method will be used as the sampling method in the research.
In this study, sample size was calculated by a priori power analysis using G*Power 3.1.9.4 software. In the analysis for analysis of variance (ANOVA: repeated measures, between factors) with two factors and repeated measures; effect size f = 0.62 (based on data obtained from previous study, Borghi-Silva et al, 2009), significance level α = 0.05, statistical power (1 - β) = 0.80, number of groups 3, number of measures 2 and correlation coefficient between measures r = 0.5. According to the calculation, it was predicted that the study would reach sufficient statistical power with a total of 24 participants, 8 participants in each group.
There will be three groups in the study: downhill walking, uphill walking, and level walking. The downhill walking and uphill walking groups will be included as the study group and the level walking group will be included as the control group. Participants will be distributed equally to the three groups. Patients will be assigned to these groups by block randomization method using https://www.randomizer.org/ website.
All three groups will be administered a 6-minute walking test at baseline, and participants will be subjected to a common 8-week, twice-weekly treadmill walking training program in which the speed is determined and increased according to the average speed they walk in this test, and in addition to this, the duration is also increased. One session of the training program will consist of warming up, loading, and cooling down on the treadmill.
During the training, the slope of the treadmill will be adjusted to +10 degrees for uphill walking, -10 degrees for downhill walking, and 0 degrees for level walking and will be kept constant for 8 weeks. A special wooden wedge apparatus will be made under the normal treadmill to give -10 downhill slope.
Primary outcome measurements will be made at baseline and at the end of week 8.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Level walking training, Downhill walking training, Uphill walking training
- Keywords
- aerobic exercise, slope, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Level walking trainingOther
For 8 weeks, level walking training will be done 2 times a week at a slope of 0 degrees.
Downhill walking trainingOther
For 8 weeks, downhill walking training will be done 2 times a week at a slope of -10 degrees.
Uphill walking trainingOther
For 8 weeks, uphill walking training will be done 2 times a week at a slope of +10 degrees.
| Study group | Role | What they receive |
|---|---|---|
| Level walking | Active comparator | It will walk at a 0-degree slope (0) throughout the research. Receives: Other: Level walking training |
| Downhill walking | Experimental | It will walk at a 10-degree downhill slope (-10) throughout the research. Receives: Other: Downhill walking training |
| Uphill walking | Experimental | It will walk at a 10-degree uphill slope (+10) throughout the research. Receives: Other: Uphill walking training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural stability test
The test reflects a person's ability to maintain the center of balance.
Measured: Up to 8 weeks.
Limits of Stability (LOS) Test
The maximum vertical angle that the body can reach while standing without losing balance is called the stability limit.
Measured: Up to 8 weeks.
Clinical Test of Sensory Integration of Balance (CTSIB)
The test assesses how well the person can integrate sensory input to maintain balance.
Measured: Up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start9 Apr 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem BEKTAŞ KARAKUŞ, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644898
- Sponsor's protocol ID
- 2024-11/491
- Status last verified
- Jun 2025
- First submitted
- 15 Oct 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Borghi-Silva A, Arena R, Castello V, Simoes RP, Martins LE, Catai AM, Costa D. Aerobic exercise training improves autonomic nervous control in patients with COPD. Respir Med. 2009 Oct;103(10):1503-10. doi: 10.1016/j.rmed.2009.04.015. Epub 2009 May 22.
PubMed 19464865Loughran KJ, Atkinson G, Beauchamp MK, Dixon J, Martin D, Rahim S, Harrison SL. Balance impairment in individuals with COPD: a systematic review with meta-analysis. Thorax. 2020 Jul;75(7):539-546. doi: 10.1136/thoraxjnl-2019-213608. Epub 2020 May 14.
PubMed 32409612Kaygusuz MH, Oral Tapan O, Tapan U, Genc S. Balance impairment and cognitive dysfunction in patients with chronic obstructive pulmonary disease under 65 years. Clin Respir J. 2022 Mar;16(3):200-207. doi: 10.1111/crj.13469. Epub 2022 Jan 26.
PubMed 35081270Jirange P, Vaishali K, Sinha MK, Bairapareddy KC, Alaparthi GK. A Cross-Sectional Study on Balance Deficits and Gait Deviations in COPD Patients. Can Respir J. 2021 Jan 6;2021:6675088. doi: 10.1155/2021/6675088. eCollection 2021.
PubMed 33505539Eymir M, Yakut H, Ozalevli S, Alpaydin AO. Static and dynamic balance impairment and relationship with disease-related factors in patients with chronic obstructive pulmonary disease : A cross-sectional study. Wien Klin Wochenschr. 2021 Nov;133(21-22):1186-1194. doi: 10.1007/s00508-021-01918-8. Epub 2021 Aug 5.
PubMed 34351502Alexander N, Strutzenberger G, Ameshofer LM, Schwameder H. Lower limb joint work and joint work contribution during downhill and uphill walking at different inclinations. J Biomech. 2017 Aug 16;61:75-80. doi: 10.1016/j.jbiomech.2017.07.001. Epub 2017 Jul 11.
PubMed 28734544
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic Exercise Training at Different Slope Types on Balance in COPD Patients
- ClinicalTrials.gov ID
- NCT06644898
- Acronym / sponsor ID
- 2024-11/491
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- aerobic exercise, slope, COPD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 16 Oct 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.
Although COPD is basically a respiratory system disease, its effects are not limited to the respiratory system. In this context, one parameter affected in COPD patients is balance. Recent studies have highlighted the importance of assessing balance and incorporating it into treatment options such as pulmonary rehabilitation. In this context, we aim to diversify the training by using different slope types (downhill, level, uphill) in aerobic exercise training, which is a strong component of pulmonary rehabilitation, and to evaluate the effect of slope type on balance. Testing different types of inclines in aerobic exercise training has the potential to result in different muscular gains. We anticipate that this may result in different balance gains.
Detailed description
The convenience sampling method will be used as the sampling method in the research.
In this study, sample size was calculated by a priori power analysis using G*Power 3.1.9.4 software. In the analysis for analysis of variance (ANOVA: repeated measures, between factors) with two factors and repeated measures; effect size f = 0.62 (based on data obtained from previous study, Borghi-Silva et al, 2009), significance level α = 0.05, statistical power (1 - β) = 0.80, number of groups 3, number of measures 2 and correlation coefficient between measures r = 0.5. According to the calculation, it was predicted that the study would reach sufficient statistical power with a total of 24 participants, 8 participants in each group.
There will be three groups in the study: downhill walking, uphill walking, and level walking. The downhill walking and uphill walking groups will be included as the study group and the level walking group will be included as the control group. Participants will be distributed equally to the three groups. Patients will be assigned to these groups by block randomization method using https://www.randomizer.org/ website.
All three groups will be administered a 6-minute walking test at baseline, and participants will be subjected to a common 8-week, twice-weekly treadmill walking training program in which the speed is determined and increased according to the average speed they walk in this test, and in addition to this, the duration is also increased. One session of the training program will consist of warming up, loading, and cooling down on the treadmill.
During the training, the slope of the treadmill will be adjusted to +10 degrees for uphill walking, -10 degrees for downhill walking, and 0 degrees for level walking and will be kept constant for 8 weeks. A special wooden wedge apparatus will be made under the normal treadmill to give -10 downhill slope.
Primary outcome measurements will be made at baseline and at the end of week 8.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Level walking | Active comparator | Other: Level walking trainingIt will walk at a 0-degree slope (0) throughout the research. |
| Downhill walking | Experimental | Other: Downhill walking trainingIt will walk at a 10-degree downhill slope (-10) throughout the research. |
| Uphill walking | Experimental | Other: Uphill walking trainingIt will walk at a 10-degree uphill slope (+10) throughout the research. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being diagnosed with COPD (A, B, E groups according to GOLD assessment)
- Ambulate on your own
- Not having any contraindications for exercise
Key exclusion criteria (9 listed)
- Being in GOLD 4 stage in spirometric evaluation
- Presence of hypoxemia
- Participation in another pulmonary rehabilitation program within the last 6 months
- Having an exacerbation in the last 1 month
- Being diagnosed with additional respiratory disease (asthma, bronchiectasis, etc.)
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 |
|---|---|---|
| Level walking trainingFor 8 weeks, level walking training will be done 2 times a week at a slope of 0 degrees. | Other | Level walking |
| Downhill walking trainingFor 8 weeks, downhill walking training will be done 2 times a week at a slope of -10 degrees. | Other | Downhill walking |
| Uphill walking trainingFor 8 weeks, uphill walking training will be done 2 times a week at a slope of +10 degrees. | Other | Uphill walking |
Primary outcome
Postural stability test
Time frame: Up to 8 weeks.
The test reflects a person's ability to maintain the center of balance.
Limits of Stability (LOS) Test
Time frame: Up to 8 weeks.
The maximum vertical angle that the body can reach while standing without losing balance is called the stability limit.
Clinical Test of Sensory Integration of Balance (CTSIB)
Time frame: Up to 8 weeks.
The test assesses how well the person can integrate sensory input to maintain balance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Background: PubMed 19464865Borghi-Silva A, Arena R, Castello V, Simoes RP, Martins LE, Catai AM, Costa D. Aerobic exercise training improves autonomic nervous control in patients with COPD. Respir Med. 2009 Oct;103(10):1503-10. doi: 10.1016/j.rmed.2009.04.015. Epub 2009 May 22.
- Background: PubMed 32409612Loughran KJ, Atkinson G, Beauchamp MK, Dixon J, Martin D, Rahim S, Harrison SL. Balance impairment in individuals with COPD: a systematic review with meta-analysis. Thorax. 2020 Jul;75(7):539-546. doi: 10.1136/thoraxjnl-2019-213608. Epub 2020 May 14.
- Background: PubMed 35081270Kaygusuz MH, Oral Tapan O, Tapan U, Genc S. Balance impairment and cognitive dysfunction in patients with chronic obstructive pulmonary disease under 65 years. Clin Respir J. 2022 Mar;16(3):200-207. doi: 10.1111/crj.13469. Epub 2022 Jan 26.
- Background: PubMed 33505539Jirange P, Vaishali K, Sinha MK, Bairapareddy KC, Alaparthi GK. A Cross-Sectional Study on Balance Deficits and Gait Deviations in COPD Patients. Can Respir J. 2021 Jan 6;2021:6675088. doi: 10.1155/2021/6675088. eCollection 2021.
- Background: PubMed 34351502Eymir M, Yakut H, Ozalevli S, Alpaydin AO. Static and dynamic balance impairment and relationship with disease-related factors in patients with chronic obstructive pulmonary disease : A cross-sectional study. Wien Klin Wochenschr. 2021 Nov;133(21-22):1186-1194. doi: 10.1007/s00508-021-01918-8. Epub 2021 Aug 5.
- Background: PubMed 28734544Alexander N, Strutzenberger G, Ameshofer LM, Schwameder H. Lower limb joint work and joint work contribution during downhill and uphill walking at different inclinations. J Biomech. 2017 Aug 16;61:75-80. doi: 10.1016/j.jbiomech.2017.07.001. Epub 2017 Jul 11.
- Individual participant dataSharing planned: Undecided
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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.
Alis Kostanoğlu, Assoc. Prof. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Level walking training, Downhill walking training and Uphill walking training in people with Pulmonary Disease, Chronic Obstructive, run by Acibadem 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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 13 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meryem Bektaş Karakuş, Research Assistant (+90 216 500 4195, meryem.bektas@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural stability test (time frame: Up to 8 weeks.). The study lists 3 primary outcomes in all. 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 NCT06644898, which also lists 6 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 13 Jun 2025.