Investigation of Walking Training With Different Slope Types in COPD Patients

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06283004
• Other study ID #: 2024-1/30
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: February 2024
• Source: Acibadem University
• Contact: Meryem Bektas Karakus, Res Asst.
• Phone: +90 216 500 4195
• Email: meryem.bektas[@]acibadem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The convenience sampling method will be used as the sampling method in the research. The pre-study sample size was calculated as 42 when the power rate was a minimum 80%, the alpha error rate was 0.05, and the effect size was 0.25 in the analyses performed with the G*Power 3.1.9.4 program. When the estimated rate of patients who could be lost to follow-up was taken as 20%, it was found that at least 51 patients should be included in the study. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 51
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Downhill walking training
For 8 weeks, downhill walking training will be done 2 times a week at a slope of -10 degrees.
• Level walking training
For 8 weeks, level walking training will be done 2 times a week at a slope of 0 degrees.
• Uphill walking training
For 8 weeks, uphill walking training will be done 2 times a week at a slope of +10 degrees.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Acibadem University	Bezmialem Vakif University

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

Erfani A, Moezy A, Mazaherinezhad A, Mousavi SA. Does Downhill Walking on Treadmill Improve Physical Status and Quality of Life of A Patient With COPD? Asian J Sports Med. 2015 Dec;6(4):e25821. doi: 10.5812/asjsm.25821. Epub 2015 Dec 1. — View Citation

Franz JR, Kram R. The effects of grade and speed on leg muscle activations during walking. Gait Posture. 2012 Jan;35(1):143-7. doi: 10.1016/j.gaitpost.2011.08.025. Epub 2011 Oct 2. — View Citation

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. — View Citation

Moezy A, Erfani A, Mazaherinezhad A, Mousavi SAJ. Downhill walking influence on physical condition and quality of life in patients with COPD: A randomized controlled trial. Med J Islam Repub Iran. 2018 Jun 14;32:49. doi: 10.14196/mjiri.32.49. eCollection 2018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minutes Walking Distance (6MWD)	6 MWD means the distance traveled in 6 MWT. Its unit is meters.	Up to 8 weeks.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	30-second sit and stand test	The result is the total number of stands within 30 seconds.	Up to 8 weeks.
Primary	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	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.
Secondary	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.
Secondary	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.