Clinical trial NCT06383065: Respiratory Physiotherapy in Type 2 Diabetes and Bariatric Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Bariatric Surgery Candidate
Keywords: Diabetes Mellitus
Respiratory Muscles
Bariatric Surgery
Type 2
Lead sponsor: Near East University, Turkey
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 (ATS/ETS, 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.

Eligibility criteria: Inclusion Criteria:

• Individuals with type 2 diabetes between the ages of 25 and 65 who applied to the General Surgery Department of Büyük Anadolu Hospital and underwent bariatric surgery

Exclusion Criteria:

* Individuals with a history of emergency surgery,
* Smoking,
* Exercising regularly in the last 6 months,
* Comorbidities with respiratory dysfunction,
* Pulmonary dysfunction,
* Acute COPD exacerbation were excluded from the study.

Primary outcomes:
measure: Respiratory Muscle Strength
timeFrame: 5 days
measure: Respiratory Function
timeFrame: 5 days
measure: Functional Capacity: The 6-minute walk test
timeFrame: 5 days
measure: Hand Grip Strength
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Near East University
Study officials:
References: