Investigation of Walking Training With Different Slope Types in COPD Patients

The Effect of Aerobic Exercise Training in Different Slope Types on Exercise Capacity, Respiratory Functions, Muscle Strength, and Functional Status in COPD Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Level walking training; Other: Downhill walking training; Other: Uphill walking training

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

• Study Contact: Name: Meryem Bektaş Karakuş, Res Asst.; Phone Number: +90 216 500 4195; Email: meryem.bektas@acibadem.edu.tr
• Study Contact Backup: Name: Alis Kostanoğlu, Assoc. Prof.; Email: Akostanoglu@bezmialem.edu.tr

Study Locations

• Turkey
  • Eyüp Sultan
    • Istanbul, Eyüp Sultan, Turkey
      • Recruiting
      • Bezmialem Vakif University, Department of Physiotherapy and Rehabilitation
      • Contact: Alis Kostanoglu; Phone Number: +90 0543 493 1848; Email: Akostanoglu@bezmialem.edu.tr

Participation Criteria

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
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

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
6 Minutes Walking Distance (6MWD)	6 MWD means the distance traveled in 6 MWT. Its unit is meters.	Up to 8 weeks.
Spirometric measurements (Forced vital capacity)	It is used to evaluate respiratory functions. It is evaluated with a spirometer. Forced vital capacity (FVC): the maximum amount of air that can be forcibly exhaled from the lungs after fully inhaling. It can be recorded in percentages or liters.	Up to 8 weeks.
Spirometric measurements (First second forced expiratory volume)	It is used to evaluate respiratory functions. It is evaluated with a spirometer. First-second forced expiratory volume (FEV1): the amount of air that can be exhaled with force in 1 second. It can be recorded in percentages or liters.	Up to 8 weeks.
Spirometric measurements (FEV1/FVC ratio)	It is used to evaluate respiratory functions. It is evaluated with a spirometer. It is calculated by dividing FEV1 by FVC. It is expressed as a percentage.	Up to 8 weeks.
Spirometric measurements (Peak Expiratory Flow)	It is used to evaluate respiratory functions. It is evaluated with a spirometer. Peak expiratory flow (PEF) is the maximum flow achieved during a forced expiration starting from the level of maximal lung inflation. It can be recorded in percentages or liters.	Up to 8 weeks.
Spirometric measurements (Maximum Intermediate Expiratory Flow)	It is used to evaluate respiratory functions. It is evaluated with a spirometer. Maximum Intermediate Expiratory Flow (FEF25-75) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. It can be recorded in percentages or liters.	Up to 8 weeks.
Muscle strength measurements (skeletal muscles)	Hip extension, knee extension, and ankle extension muscle strength will be measured with a handheld dynamometer. The results are recorded in Newtons.	Up to 8 weeks.
Muscle strength measurements (respiratory muscles)	The strength of the respiratory muscles will be assessed and recorded as maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) with a device that allows the measurement of intraoral pressures, which is an indirect indicator of the strength of these muscles. In this device, measurements are based on recording the highest average pressure sustained for one second during inspiration and expiration against a closed valve. Measurements are recorded in cmH2O.	Up to 8 weeks.
30-second sit and stand test	The result is the total number of stands within 30 seconds.	Up to 8 weeks.
Functional performance inventory	It is a valid and reliable measurement tool used to assess functional performance in COPD patients. It consists of 6 sub-dimensions (body care, household maintenance, physical exercise, recreation, spiritual activities, social activities) and a total of 65 items. The questions are answered by choosing from the following options: "I can do the activity easily without any difficulty (3 points), I can do it with some difficulty (2 points), I can do it with much difficulty (1 point), I can no longer do this activity due to my health reasons (0 points), I do not prefer it (0 points)" and are scored according to the specified scores. Each sub-dimension and total performance is calculated as an average. The lowest score is 0 and the highest score is 3. Higher score means better functional performance. Turkish validation study of the questionnaire in COPD patients was conducted.	Up to 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea	It will be reported by the participant using the modified borg scale (between 0-10 points). On this scale, 0 is the lowest score and means absent, while 10 is the highest score and indicates that the condition is most severe.	Up to 8 weeks.
Fatigue	It will be reported by the participant using the modified borg scale (between 0-10 points).On this scale, 0 is the lowest score and means absent, while 10 is the highest score and indicates that the condition is most severe.	Up to 8 weeks.
Level of exertion	It will be reported by the participant using the modified borg scale (between 0-10 points). On this scale, 0 is the lowest score and means absent, while 10 is the highest score and indicates that the condition is most severe.	Up to 8 weeks.

Collaborators and Investigators

• Sponsor: Acibadem University
• Collaborators: Bezmialem Vakif University

Publications and helpful links

General Publications

• 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.
• Camillo CA, Burtin C, Hornikx M, Demeyer H, De Bent K, van Remoortel H, Osadnik CR, Janssens W, Troosters T. Physiological responses during downhill walking: A new exercise modality for subjects with chronic obstructive pulmonary disease? Chron Respir Dis. 2015 May;12(2):155-64. doi: 10.1177/1479972315575717. Epub 2015 Mar 10.
• Camillo CA, Osadnik CR, Burtin C, Everaerts S, Hornikx M, Demeyer H, Loeckx M, Rodrigues FM, Maes K, Gayan-Ramirez G, Janssens W, Troosters T. Effects of downhill walking in pulmonary rehabilitation for patients with COPD: a randomised controlled trial. Eur Respir J. 2020 Sep 17;56(3):2000639. doi: 10.1183/13993003.00639-2020. Print 2020 Sep.
• Leidy NK. Psychometric properties of the functional performance inventory in patients with chronic obstructive pulmonary disease. Nurs Res. 1999 Jan-Feb;48(1):20-8. doi: 10.1097/00006199-199901000-00004.
• 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.
• Vallera DA, Blazar BR. Depressed leukocyte reconstitution and engraftment in murine recipients of T cell-depleted histoincompatible marrow pretreated with interleukin 3. Transplantation. 1988 Oct;46(4):616-20. doi: 10.1097/00007890-198810000-00039. No abstract available.
• Nordback I, Lauslahti K. Clinicopathologic and histochemical study of ovarian clear cell carcinoma. Int J Gynaecol Obstet. 1980 Sep-Oct;18(2):85-9. doi: 10.1002/j.1879-3479.1980.tb00251.x.
• Brooks RG. Postgraduate training in child psychiatry: the content of the curriculum. Am J Psychiatry. 1973 Apr;130(4):491-3. doi: 10.1176/ajp.130.4.491. No abstract available.

Study record dates

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: February 12, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 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

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2024-1/30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No