The Effect of Gait Training Using Different Slope Types on Balance in COPD Patients

June 10, 2025 updated by: Meryem BEKTAŞ KARAKUŞ, Acibadem University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Eyüp Sultan
      • Istanbul, Eyüp Sultan, Turkey
        • Recruiting
        • Bezmialem Vakif University, Department of Physiotherapy and Rehabilitation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Level walking
It will walk at a 0-degree slope (0) throughout the research.
Other: Level walking training
For 8 weeks, level walking training will be done 2 times a week at a slope of 0 degrees.
Experimental: Downhill walking
It will walk at a 10-degree downhill slope (-10) throughout the research.
Other: Downhill walking training
For 8 weeks, downhill walking training will be done 2 times a week at a slope of -10 degrees.
Experimental: Uphill walking
It will walk at a 10-degree uphill slope (+10) throughout the research.
Other: Uphill walking training
For 8 weeks, uphill walking training will be done 2 times a week at a slope of +10 degrees.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural stability test
Time Frame: Up to 8 weeks.
The test reflects a person's ability to maintain the center of balance.
Up to 8 weeks.
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.
Up to 8 weeks.
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.
Up to 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 15, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-11/491

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Pulmonary Disease, Chronic Obstructive

Clinical Trials on Level walking training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe