Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383065
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2024-04-17
Brief Title:
Respiratory Physiotherapy in Type 2 Diabetes and Bariatric Surgery
Sponsor:
Near East University Turkey
Organization:
Near East University Turkey
Study Overview
Official Title:
Early Effects of Physiotherapy Program Applied Before and After Bariatric Surgery on Respiratory Function Respiratory Muscle Strength and Functional Capacity in Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2024-04
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:
The aim of this study is to investigate the early effects of Inspiratory Muscle Training IMT applied before and after bariatric surgery on respiratory function respiratory muscle strength and functional capacity in individuals with type 2 diabetes
The study will be conducted with 40 individuals with type 2 diabetes aged between 25-65 Individuals will be randomly assigned to the IMT trained at 30 of maximum inspiratory pressure with an IMT threshold device and control group As measurement parameters a 6-minute walk test for functional capacity a spirometry test for respiratory function and a portable device Cosmed Pony FX Desktop Spirometer USA will be used for respiratory muscle strength Hand grip strength will be measured with a Baseline dynamometer All measurements will be repeated on the first day before surgery and on the fourth day before discharge after surgery
The study will be conducted with 40 individuals with type 2 diabetes aged between 25-65 Individuals will be randomly assigned to the IMT trained at 30 of maximum inspiratory pressure with an IMT threshold device and control group As measurement parameters a 6-minute walk test for functional capacity a spirometry test for respiratory function and a portable device Cosmed Pony FX Desktop Spirometer USA will be used for respiratory muscle strength Hand grip strength will be measured with a Baseline dynamometer All measurements will be repeated on the first day before surgery and on the fourth day before discharge after surgery
Detailed Description:
All patients will be evaluated with the same examinations on the first day before surgery and on the fourth day after surgery before discharge Individuals in the control group will only apply the hospital routine exercise program in the postoperative period While individuals in the IMT group will receive only IMT on the first day before surgery they will also receive the hospital routine exercise program in addition to IMT treatment from the first day to the fourth day after surgery During the training the patient will undergo two 20-minute training sessions with a linear pressure resistance device wearing a nose clip Threshold IMT-Health Scan Products USA in a sitting position ATSETS 2002 IMT training load will be adjusted according to the 30-40 pressure determined in the MIP measurement In the postoperative period all patients will receive incentive spirometry breathing exercises and ambulation exercises as part of the hospital routine exercise program
Study Oversight
Has Oversight DMC:
None
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?:
None