Type 2 DiabetesNCT06383065
Respiratory Physiotherapy in Type 2 Diabetes and Bariatric Surgery
A study testing IMT Group in people with Type 2 Diabetes and Bariatric Surgery Candidate, run by Near East University, Turkey at 1 site in Cyprus.
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Bariatric Surgery Candidate
- What is being tested?
- IMT Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Feb 2020to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- IMT Group
- Keywords
- Diabetes Mellitus, Respiratory Muscles, Bariatric Surgery, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMT GroupOther
Inspiratory muscle training involves breathing exercises using a pressure threshold device to strengthen the muscles involved in breathing in.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Feb 2020
- Primary completion30 Apr 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melis Bagkur, Near East University, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383065
- Sponsor's protocol ID
- YDU/2020/76-1007
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06383065
- Acronym / sponsor ID
- YDU/2020/76-1007
- Conditions
- Type 2 Diabetes, Bariatric Surgery Candidate
- Keywords
- Diabetes Mellitus, Respiratory Muscles, Bariatric Surgery, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMT group | Experimental | Other: IMT GroupIn 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. |
| Control Group | No intervention | –Individuals in the control group will be applied only the hospital routine exercise program in the postoperative period. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- Individuals with a history of emergency surgery,
- Smoking,
- Exercising regularly in the last 6 months,
- Comorbidities with respiratory dysfunction,
- Pulmonary dysfunction,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMT GroupInspiratory muscle training involves breathing exercises using a pressure threshold device to strengthen the muscles involved in breathing in. | Other | IMT group |
Primary outcome
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.
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
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMT Group in people with Type 2 Diabetes and Bariatric Surgery Candidate, run by Near East University, Turkey at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Muscle Strength (time frame: 5 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.