Respiratory Physiotherapy in Type 2 Diabetes and Bariatric Surgery

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06383065
• Other study ID #: YDU/2020/76-1007
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: April 2024
• Source: Near East University, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 30, 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• IMT Group
Inspiratory muscle training involves breathing exercises using a pressure threshold device to strengthen the muscles involved in breathing in.

Locations

Country	Name	City	State
Cyprus	Near East University	Nicosia

Sponsors (1)

Lead Sponsor	Collaborator
Near East University, Turkey

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Muscle Strength	Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) were evaluated with a portable device (Cosmed Pony FX Desktop Spirometer, USA). MIP measurement was performed at the residual volume.	5 days
Primary	Respiratory Function	The respiratory function measured using a spirometer device (Cosmed Srl, Cosmed Pony Fx, Rome, Italy) consisted of physiological measurement of the volume and flow per second of the air entering and exiting the lungs of the individual during inspiration and expiration	5 days
Primary	Functional Capacity: The 6-minute walk test	The 6-minute walk test is a practical test that can easily be applied at the level of submaximal effort used in the evaluation of functional capacity. The test is performed indoors, in a 30-meter flat, non-slippery place with marked two ends, and where there is no material to hinder the person being tested.	5 days
Primary	Hand Grip Strength	Grip strength in the dominant and nondominant hand was evaluated in 'kg' using the grip hand dynamometer (Baseline Smedley, Model 12-0286, White Plains, NY, USA).	5 days