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NCT Number: NCT06383065

Respiratory Physiotherapy in Type 2 Diabetes and Bariatric Surgery

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.

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Key information

Conditions

Type 2 Diabetes Bariatric Surgery Candidate Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Near East University

Nicosia, Cyprus

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMT Group

Other

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

Primary outcomes

  1. Respiratory Muscle Strength

    Time frame: 5 days

    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.

  2. Respiratory Function

    Time frame: 5 days

    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

  3. Functional Capacity: The 6-minute walk test

    Time frame: 5 days

    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.

  4. Hand Grip Strength

    Time frame: 5 days

    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).

Sponsors and collaborators

Lead sponsor

Near East University, Turkey

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 25, 2024
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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