Clinical trial NCT06283004: Investigation of Walking Training With Different Slope Types in COPD Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Bezmialem Vakif University
First posted: 2024-02-28
Enrollment: 51
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: 6 Minutes Walking Distance (6MWD)
timeFrame: Up to 8 weeks.
measure: Spirometric measurements (Forced vital capacity)
timeFrame: Up to 8 weeks.
measure: Spirometric measurements (First second forced expiratory volume)
timeFrame: Up to 8 weeks.
measure: Spirometric measurements (FEV1/FVC ratio)
timeFrame: Up to 8 weeks.
measure: Spirometric measurements (Peak Expiratory Flow)
timeFrame: Up to 8 weeks.
measure: Spirometric measurements (Maximum Intermediate Expiratory Flow)
timeFrame: Up to 8 weeks.
measure: Muscle strength measurements (skeletal muscles)
timeFrame: Up to 8 weeks.
measure: Muscle strength measurements (respiratory muscles)
timeFrame: Up to 8 weeks.
measure: 30-second sit and stand test
timeFrame: Up to 8 weeks.
measure: Functional performance inventory
timeFrame: Up to 8 weeks.
Secondary outcomes:
measure: Dyspnea
timeFrame: Up to 8 weeks.
measure: Fatigue
timeFrame: Up to 8 weeks.
measure: Level of exertion
timeFrame: Up to 8 weeks.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University, Department of Physiotherapy and Rehabilitation
state: Eyüp Sultan
Study officials:
References:
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citation: 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.
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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.
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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.
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