Type 2 Diabetes MellitusNCT07921901
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
A study testing Combined Excerse Training and Functional Inspiratory Muscle Training in people with Type 2 Diabetes Mellitus, run by İrem Çaylak Yetüt at 1 site in Turkey (Türkiye).
Trial summary
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease that may impair exercise capacity, respiratory muscle strength, balance, and quality of life, and increase fatigue. Exercise training is an important component of diabetes management. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Combined Excerse Training and Functional Inspiratory Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having been diagnosed with type 2 diabetes mellitus (T2DM) for at least one year and being medically stable at the time of enrollment.
- Age between 40 and 65 years of age.
- Using oral hypoglycemic medications or insulin.
- Having a pre-exercise blood glucose level between 90 and 250 mg/dL.
- Having an HbA1c level between 6.5% and 11%.
- Having access to an internet connection.
- Being able to communicate in Turkish.
- Having no visual impairment.
Who cannot join
- Having participated in an exercise program within the previous six months.
- Having a body mass index (BMI) ≥35 kg/m².
- Having type 1 diabetes mellitus.
- Having chronic obstructive pulmonary disease (COPD), interstitial lung disease, or asthma.
- Having coronary artery disease.
- Having neurological disorders.
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- Having musculoskeletal problems that may prevent participation in exercise training.
- Having uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥120 mmHg).
- Being pregnant or breastfeeding.
- Having a thyroid disorder.
- Having diabetic ulcers or peripheral neuropathy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Istanbul, 34147
İrem Çaylak Yetüt, PhD student, +905397685616, iremcaylakyetut@ogr.iuc.edu.tr
Gökşen Kuran Aslan, Proffessor, goksen.kuranaslan@iuc.edu.tr
About this study
Official title: Comparison of the Effects of Online Functional Inspiratory Muscle Training and Combined Exercise Training on Functional Capacity, Fatigue, and Balance in Individuals With Type 2 Diabetes
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease that may impair exercise capacity, respiratory muscle strength, balance, and quality of life, and increase fatigue. Exercise training is an important component of diabetes management. However, the effects of functional inspiratory muscle training, which combines breathing exercises with functional movements and postural control activities, have not been sufficiently investigated in individuals with T2DM. This study aims to compare the effects of online functional inspiratory muscle training and combined exercise training on functional capacity, fatigue, and balance in individuals with T2DM. The study will also investigate changes in respiratory muscle strength, peripheral muscle strength, quality of life, and activities of daily living. This prospective, single-blind, randomized controlled trial will include 39 individuals aged 40-65 years who have been diagnosed with T2DM. Participants will be randomly assigned to three groups in a 1:1:1 ratio: a combined exercise training group, a functional inspiratory muscle training group, and a control group. Both exercise groups will participate in an eight-week home-based training program consisting of three sessions per week. Two sessions will be supervised online by a physiotherapist, while one session will be performed independently. The combined exercise training group will perform aerobic, resistance, and breathing exercises. The functional inspiratory muscle training group will perform progressive inspiratory muscle training combined with core stabilization, postural control, and functional exercises. The control group will receive physical activity counseling and an informational brochure without participating in a structured exercise intervention. Participants will be evaluated at baseline and after the eight-week intervention. The primary outcomes will be functional capacity, fatigue, and balance, assessed using the Six-Minute Walk Test, Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), Timed Up and Go Test, and the short version of the Activities-specific Balance Confidence Scale. Secondary outcomes will include respiratory and peripheral muscle strength, lower-extremity functional performance, diabetes-related quality of life, instrumental activities of daily living, and anthropometric measurements. This study aims to provide evidence regarding the effectiveness of online functional inspiratory muscle training compared with combined exercise training in improving physical function and balance in individuals with T2DM.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Combined Excerse Training, Functional Inspiratory Muscle Training, Usual Care
- Keywords
- Type 2 Diabetes mellitus, Inspiratory Muscle Training, Combined Exercise Training, Functional Capacity
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Excerse TrainingBehavioural
Participants allocated to the combined exercise training group will receive an eight-week online exercise program supervised by a physiotherapist. The program will include aerobic, resistance, and balance exercises aimed at improving functional capacity, peripheral muscle strength, and postural balance. Exercise intensity and progression will be individualized according to each participant's functional capacity and exercise tolerance.
Functional Inspiratory Muscle TrainingBehavioural
Participants allocated to the functional inspiratory muscle training group will receive an eight-week online inspiratory muscle training program using an inspiratory muscle training device. Training will be performed at 30-40% of maximal inspiratory pressure (MIP), for approximately 30 minutes per day, seven days per week. One session per week will be supervised online by a physiotherapist. Training intensity will be adjusted according to individual MIP measurements and exercise tolerance.
Usual CareOther
Participants allocated to the control group will continue their usual medical care during the eight-week study period. They will receive general education on type 2 diabetes management, the importance of physical activity, and healthy lifestyle habits. However, they will not participate in a structured exercise program or receive functional inspiratory muscle training or combined exercise training as part of the study.
| Study group | Role | What they receive |
|---|---|---|
| Combined Exercise Training Group | Experimental | Not described Receives: Behavioral: Combined Excerse Training |
| Functional Inspiratory Muscle Training Group | Experimental | Not described Receives: Behavioral: Functional Inspiratory Muscle Training |
| Control Group | Experimental | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
six-minute walk distance
Functional capacity will be assessed using the Six-Minute Walk Test (6MWT). Participants will be instructed to walk as far as possible within six minutes. The total distance walked will be recorded in meters. Higher distances indicate better functional capacity.
Measured: baseline and week 8
Fatigue Level Assessed by FACİT-Fatigue Scale
Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale. The scale consists of 13 items, with a total score ranging from 0 to 52. Higher scores indicate lower fatigue levels and better fatigue-related quality of life.
Measured: Baseline and week 8
Dynamic Balance Assessed by Timed Up and Go Test (TUG)
Dynamic balance and functional mobility will be assessed using the Timed Up and Go (TUG) Test. Participants will stand up from a chair, walk three meters, turn around, return to the chair, and sit down. The completion time will be recorded in seconds. Lower values indicate better performance.
Measured: Baseline and week 8
Balance Confidence Assessed by Activities-specific Balance Confidence Scale (ABC)
Balance confidence will be assessed using the Activities-specific Balance Confidence (ABC) Scale. Participants will rate their confidence in maintaining balance during daily activities. Scores range from 0% to 100%, with higher scores indicating greater balance confidence.
Measured: Baseline and week 8
Secondary outcomes (4)
Peripheral Muscle Strength Assessed by Handheld Dynamometry
Peripheral muscle strength will be assessed using a handheld dynamometer (KFORCE). Muscle strength measurements will be performed bilaterally for the selected upper- and lower-extremity muscle groups using standardized testing positions. Results will be recorded in the measurement units provided by the device. Higher values indicate greater muscle strength.
Measured: Baseline and week 8
Maximal Expiratory Pressure
Expiratory muscle strength will be assessed by measuring maximal expiratory pressure (MEP) with a respiratory pressure-measuring device. Results will be expressed in cmH2O. Higher values indicate greater expiratory muscle strength.
Measured: Baseline and week 8
Diabetes-Related Quality of Life Assessed by DQoL-BCI
Diabetes-related quality of life will be assessed using the Diabetes Quality of Life Brief Clinical Inventory (DQoL-BCI). This 15-item questionnaire evaluates the impact of diabetes on daily life, satisfaction with diabetes management, and diabetes-related concerns. Changes in quality of life will be assessed before and after the eight-week intervention.
Measured: Baseline and week 8
Instrumental Activities of Daily Living Assessed by Lawton-Brody Scale
Instrumental activities of daily living will be assessed using the Lawton-Brody Instrumental Activities of Daily Living Scale. The scale evaluates independence in daily activities such as telephone use, shopping, food preparation, housekeeping, laundry, transportation, medication management, and financial management. Higher scores indicate greater independence in instrumental activities of daily living.
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- İrem Çaylak Yetüt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, İrem Çaylak Yetüt, Istanbul University - Cerrahpasa
- Investigators
- Gökşen Kuran Aslan, Proffessor, Study chair, Istanbul University - CerrahpasaLütfullah Caştur, MD, Study director, Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921901
- Sponsor's protocol ID
- IUC-T2DM-IMT-2026
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Online Functional Inspiratory Muscle Training and Combined Exercise Training on Functional Capacity, Fatigue, and Balance in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07921901
- Acronym / sponsor ID
- IUC-T2DM-IMT-2026
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes mellitus, Inspiratory Muscle Training, Combined Exercise Training, Functional Capacity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- İrem Çaylak YetütUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Nov 2026 (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.
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease that may impair exercise capacity, respiratory muscle strength, balance, and quality of life, and increase fatigue. Exercise training is an important component of diabetes management. However, the effects of functional inspiratory muscle training, which combines breathing exercises with functional movements and postural control activities, have not been sufficiently investigated in individuals with T2DM. This study aims to compare the effects of online functional inspiratory muscle training and combined exercise training on functional capacity, fatigue, and balance in individuals with T2DM. The study will also investigate changes in respiratory muscle strength, peripheral muscle strength, quality of life, and activities of daily living. This prospective, single-blind, randomized controlled trial will include 39 individuals aged 40-65 years who have been diagnosed with T2DM. Participants will be randomly assigned to three groups in a 1:1:1 ratio: a combined exercise training group, a functional inspiratory muscle training group, and a control group. Both exercise groups will participate in an eight-week home-based training program consisting of three sessions per week. Two sessions will be supervised online by a physiotherapist, while one session will be performed independently. The combined exercise training group will perform aerobic, resistance, and breathing exercises. The functional inspiratory muscle training group will perform progressive inspiratory muscle training combined with core stabilization, postural control, and functional exercises. The control group will receive physical activity counseling and an informational brochure without participating in a structured exercise intervention. Participants will be evaluated at baseline and after the eight-week intervention. The primary outcomes will be functional capacity, fatigue, and balance, assessed using the Six-Minute Walk Test, Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), Timed Up and Go Test, and the short version of the Activities-specific Balance Confidence Scale. Secondary outcomes will include respiratory and peripheral muscle strength, lower-extremity functional performance, diabetes-related quality of life, instrumental activities of daily living, and anthropometric measurements. This study aims to provide evidence regarding the effectiveness of online functional inspiratory muscle training compared with combined exercise training in improving physical function and balance in individuals with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined Exercise Training Group | Experimental | Behavioral: Combined Excerse Training |
| Functional Inspiratory Muscle Training Group | Experimental | Behavioral: Functional Inspiratory Muscle Training |
| Control Group | Experimental | Other: Usual Care |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Having been diagnosed with type 2 diabetes mellitus (T2DM) for at least one year and being medically stable at the time of enrollment.
- Age between 40 and 65 years of age.
- Using oral hypoglycemic medications or insulin.
- Having a pre-exercise blood glucose level between 90 and 250 mg/dL.
- Having an HbA1c level between 6.5% and 11%.
Key exclusion criteria (11 listed)
- Having participated in an exercise program within the previous six months.
- Having a body mass index (BMI) ≥35 kg/m².
- Having type 1 diabetes mellitus.
- Having chronic obstructive pulmonary disease (COPD), interstitial lung disease, or asthma.
- Having coronary artery disease.
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 |
|---|---|---|
| Combined Excerse TrainingParticipants allocated to the combined exercise training group will receive an eight-week online exercise program supervised by a physiotherapist. The program will include aerobic, resistance, and balance exercises aimed at improving functional capacity, peripheral muscle strength, and postural balance. Exercise intensity and progression will be individualized according to each participant's functional capacity and exercise tolerance. | Behavioural | Combined Exercise Training Group |
| Functional Inspiratory Muscle TrainingParticipants allocated to the functional inspiratory muscle training group will receive an eight-week online inspiratory muscle training program using an inspiratory muscle training device. Training will be performed at 30-40% of maximal inspiratory pressure (MIP), for approximately 30 minutes per day, seven days per week. One session per week will be supervised online by a physiotherapist. Training intensity will be adjusted according to individual MIP measurements and exercise tolerance. | Behavioural | Functional Inspiratory Muscle Training Group |
| Usual CareParticipants allocated to the control group will continue their usual medical care during the eight-week study period. They will receive general education on type 2 diabetes management, the importance of physical activity, and healthy lifestyle habits. However, they will not participate in a structured exercise program or receive functional inspiratory muscle training or combined exercise training as part of the study. | Other | Control Group |
Primary outcome
six-minute walk distance
Time frame: baseline and week 8
Functional capacity will be assessed using the Six-Minute Walk Test (6MWT). Participants will be instructed to walk as far as possible within six minutes. The total distance walked will be recorded in meters. Higher distances indicate better functional capacity.
Fatigue Level Assessed by FACİT-Fatigue Scale
Time frame: Baseline and week 8
Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale. The scale consists of 13 items, with a total score ranging from 0 to 52. Higher scores indicate lower fatigue levels and better fatigue-related quality of life.
Dynamic Balance Assessed by Timed Up and Go Test (TUG)
Time frame: Baseline and week 8
Dynamic balance and functional mobility will be assessed using the Timed Up and Go (TUG) Test. Participants will stand up from a chair, walk three meters, turn around, return to the chair, and sit down. The completion time will be recorded in seconds. Lower values indicate better performance.
Balance Confidence Assessed by Activities-specific Balance Confidence Scale (ABC)
Time frame: Baseline and week 8
Balance confidence will be assessed using the Activities-specific Balance Confidence (ABC) Scale. Participants will rate their confidence in maintaining balance during daily activities. Scores range from 0% to 100%, with higher scores indicating greater balance confidence.
4 secondary outcomes
Peripheral Muscle Strength Assessed by Handheld Dynamometry
Time frame: Baseline and week 8
Maximal Expiratory Pressure
Time frame: Baseline and week 8
Diabetes-Related Quality of Life Assessed by DQoL-BCI
Time frame: Baseline and week 8
Instrumental Activities of Daily Living Assessed by Lawton-Brody Scale
Time frame: Baseline and week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Gökşen Kuran Aslan, Proffessor study chair
Istanbul University - Cerrahpasa
Lütfullah Caştur, MD study director
Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Excerse Training and Functional Inspiratory Muscle Training in people with Type 2 Diabetes Mellitus, run by İrem Çaylak Yetüt at 1 site in Turkey (Türkiye).
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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 6 Nov 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İrem Çaylak Yetüt, PhD Student (+905397685616, iremcaylakyetut@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
six-minute walk distance (time frame: baseline and week 8). 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 6 Nov 2026.