Respiratory Physiotherapy in Type 2 Diabetes and Bariatric Surgery

NCT06383065 | Completed

• 1 other identifier: YDU/2020/76-1007
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Bariatric Surgery Candidate

Keywords

Diabetes Mellitus; Respiratory Muscles; Bariatric Surgery; Type 2

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

IMT group

EXPERIMENTAL

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.

Other: IMT Group

Control Group

NO INTERVENTION

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

Interventions

IMT Group OTHER

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

IMT group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Near East University

Nicosia, Cyprus

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist prof

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 25, 2024
• Study Start: February 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: January 30, 2022
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)