Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-29 @ 4:28 AM
Study NCT ID:
NCT06283004
Status:
RECRUITING
Last Update Posted:
2025-06-13
First Post:
2024-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Walking Training With Different Slope Types in COPD Patients
Sponsor:
Acibadem University
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: