An interventional study of Combined Excerse Training and Functional Inspiratory Muscle Training in Type 2 Diabetes Mellitus, sponsored by İrem Çaylak Yetüt. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by İrem Çaylak Yetüt · Not applicable, Interventional, and Treatment
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 39 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →This is the only study on the registry with İrem Çaylak Yetüt as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Combined Excerse Training
Behavioral: Functional Inspiratory Muscle Training
Other: Usual Care
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and week 8
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and week 8
Lower Extremity Functional Performance Assessed by the 30-Second Sit-to-Stand Test
Lower extremity functional performance will be assessed using the 30-Second Sit-to-Stand Test (30STS). Participants will be instructed to stand up fully from a seated position and sit down as many times as possible within 30 seconds, without using their arms for assistance. The total number of correctly completed repetitions will be recorded. Higher repetition counts indicate better lower extremity functional performance.
Time frame: Baseline and week 8
Waist Circumference
Waist circumference will be measured using a non-elastic measuring tape and recorded in centimeters (cm). Measurements will be performed using a standardized anatomical landmark and measurement procedure. Changes in waist circumference will be evaluated from baseline to the end of the eight-week intervention.
Time frame: Baseline and week 8
Plan to share: No
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