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Respiratory Physiotherapy in Type 2 Diabetes and Bariatric Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06383065
Enrollment
40
Registered
2024-04-25
Start date
2020-02-01
Completion date
2022-01-30
Last updated
2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Type 2 Diabetes

Keywords

Diabetes Mellitus, Respiratory Muscles, Bariatric Surgery, Type 2

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.

Interventions

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

Sponsors

Near East University, Turkey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Respiratory Muscle Strength5 daysMaximal 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.
Respiratory Function5 daysThe 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
Functional Capacity: The 6-minute walk test5 daysThe 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.
Hand Grip Strength5 daysGrip 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).

Countries

Cyprus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026