NCT06644898

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Apr 2025Jun 2026

First Submitted

Initial submission to the registry

October 15, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

April 9, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

October 15, 2024

Last Update Submit

June 10, 2025

Conditions

Keywords

aerobic exercise, slope, COPD

Outcome Measures

Primary Outcomes (3)

  • Postural stability test

    The test reflects a person's ability to maintain the center of balance.

    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.

    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.

    Up to 8 weeks.

Study Arms (3)

Level walking

ACTIVE COMPARATOR

It will walk at a 0-degree slope (0) throughout the research.

Other: Level walking training

Downhill walking

EXPERIMENTAL

It will walk at a 10-degree downhill slope (-10) throughout the research.

Other: Downhill walking training

Uphill walking

EXPERIMENTAL

It will walk at a 10-degree uphill slope (+10) throughout the research.

Other: Uphill walking training

Interventions

For 8 weeks, level walking training will be done 2 times a week at a slope of 0 degrees.

Level walking

For 8 weeks, downhill walking training will be done 2 times a week at a slope of -10 degrees.

Downhill walking

For 8 weeks, uphill walking training will be done 2 times a week at a slope of +10 degrees.

Uphill walking

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being diagnosed with COPD (A, B, E groups according to GOLD assessment)
  • Ambulate on your own
  • Not having any contraindications for exercise

You may not qualify if:

  • 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
  • Having an orthopedic, neurological or cardiac disease that affects exercise
  • Having uncontrolled hypertension or diabetes
  • Presence of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University, Department of Physiotherapy and Rehabilitation

Istanbul, Eyüp Sultan, Turkey (Türkiye)

RECRUITING

Related Publications (6)

  • 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.

    PMID: 19464865BACKGROUND
  • Loughran 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.

    PMID: 32409612BACKGROUND
  • Kaygusuz 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.

    PMID: 35081270BACKGROUND
  • Jirange 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.

    PMID: 33505539BACKGROUND
  • Eymir 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.

    PMID: 34351502BACKGROUND
  • Alexander 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.

    PMID: 28734544BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Meryem Bektaş Karakuş, Research Assistant

CONTACT

Alis Kostanoğlu, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 15, 2024

First Posted

October 16, 2024

Study Start

April 9, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

June 13, 2025

Record last verified: 2025-06

Locations