Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644898
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
The Effect of Gait Training Using Different Slope Types on Balance in COPD Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Aerobic Exercise Training At Different Slope Types on Balance in COPD Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although COPD is basically a respiratory system disease its effects are not limited to the respiratory system In this context one parameter affected in COPD patients is balance Recent studies have highlighted the importance of assessing balance and incorporating it into treatment options such as pulmonary rehabilitation In this context we aim to diversify the training by using different slope types downhill level uphill in aerobic exercise training which is a strong component of pulmonary rehabilitation and to evaluate the effect of slope type on balance Testing different types of inclines in aerobic exercise training has the potential to result in different muscular gains We anticipate that this may result in different balance gains
Detailed 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 005 and the effect size was 025 in the analyses performed with the GPower 3194 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 httpswwwrandomizerorg 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
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 httpswwwrandomizerorg 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None