Investigation of Walking Training With Different Slope Types in COPD Patients

NCT06283004 | Recruiting

• 1 other identifier: 2024-1/30
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (3)

• Dyspnea

  Up to 8 weeks.

• Fatigue

  Up to 8 weeks.

• Level of exertion

  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

Downhill walking training OTHER

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

Downhill walking

Level walking training OTHER

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

Level walking

Uphill walking training OTHER

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

Uphill walking

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• To be mentally appropriate (score 24 points and above in the mini mental test)

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

Sponsors & Collaborators

• Acibadem University: lead
• Bezmialem Vakif University: collaborator

Study Sites (1)

Bezmialem Vakif University, Department of Physiotherapy and Rehabilitation

Istanbul, Eyüp Sultan, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• 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: 19464865 BACKGROUND

• 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.

  PMID: 3262943 BACKGROUND

• 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: 28734544 BACKGROUND

• 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.

  PMID: 6108258 BACKGROUND

• 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.

  PMID: 25758676 BACKGROUND

• 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.

  PMID: 4691311 BACKGROUND

• 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.

  PMID: 32444407 BACKGROUND

• 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.

  PMID: 10029398 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Meryem Bektaş Karakuş, Res Asst.

CONTACT

+90 216 500 4195; meryem.bektas@acibadem.edu.tr

Alis Kostanoğlu, Assoc. Prof.

CONTACT

Akostanoglu@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Principal Investigator

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 28, 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

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)