Respiratory Physiotherapy in Type 2 Diabetes and Bariatric Surgery

NCT ID: NCT06383065

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2022-01-30

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.

Conditions

Type 2 Diabetes; Bariatric Surgery Candidate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMT group

In the IMT group, only IMT will be applied on the first day before surgery, and the hospital routine exercise program will be applied in addition to IMT treatment from the first day to the fourth postoperative day.

Group Type: EXPERIMENTAL

IMT Group

Intervention Type: OTHER

Inspiratory muscle training involves breathing exercises using a pressure threshold device to strengthen the muscles involved in breathing in.

Control Group

Individuals in the control group will be applied only the hospital routine exercise program in the postoperative period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

IMT Group

Inspiratory muscle training involves breathing exercises using a pressure threshold device to strengthen the muscles involved in breathing in.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Near East University, Turkey

OTHER

Sponsor Role: lead

Responsible Party

Melis Bagkur

assist prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Near East University

Nicosia, , Cyprus

Countries

Cyprus

Other Identifiers

YDU/2020/76-1007

Identifier Type: -

Identifier Source: org_study_id