Investigation of Walking Training With Different Slope Types in COPD Patients

NCT ID: NCT06283004

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-09
• Study Completion Date: 2026-06-01

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a disease that continues to generate a great deal of research and this research must continue, both because it is not completely curable and because of the large patient population. The importance and benefits of exercise training in COPD patients are clear. One of the most preferred types of exercise training is the so-called aerobic exercise training, which typically takes the form of walking. A typical walking training does not use a slope or may include an uphill slope. However, recently there have been publications about downhill walking and its benefits in COPD. Walking on a level, uphill, and downhill slope may have the potential to result in different gains by using different muscle groups more. Therefore, this study aimed to compare the effects of walking training on exercise capacity, respiratory functions, muscle strength, and functional status in COPD patients with three different slope types: level, uphill, and downhill.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Level walking

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

Group Type: ACTIVE_COMPARATOR

Level walking training

Intervention Type: OTHER

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

Downhill walking

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

Group Type: EXPERIMENTAL

Downhill walking training

Intervention Type: OTHER

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

Uphill walking

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

Group Type: EXPERIMENTAL

Uphill walking training

Intervention Type: OTHER

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

Interventions

Downhill walking training

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

Intervention Type: OTHER

Level walking training

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

Intervention Type: OTHER

Uphill walking training

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being diagnosed with COPD (A, B, E groups according to GOLD assessment)
• Ambulate on your own
• Not having any contraindications for exercise
• To be mentally appropriate (score 24 points and above in the mini mental test)

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: collaborator

Acibadem University

OTHER

Sponsor Role: lead

Responsible Party

Meryem BEKTAŞ KARAKUŞ

Research Assistant, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bezmialem Vakif University, Department of Physiotherapy and Rehabilitation

Istanbul, Eyüp Sultan, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Meryem Bektaş Karakuş, Res Asst.

Role: CONTACT

meryem.bektas@acibadem.edu.tr

+90 216 500 4195

Alis Kostanoğlu, Assoc. Prof.

Role: CONTACT

Akostanoglu@bezmialem.edu.tr

Facility Contacts

Alis Kostanoglu

Role: primary

Akostanoglu@bezmialem.edu.tr

+90 0543 493 1848

References

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Other Identifiers

2024-1/30

Identifier Type: -

Identifier Source: org_study_id