NCT07921901Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
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
Source: ClinicalTrials.gov · Last updated 6 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- First submitted
- 2 Nov 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- İrem Çaylak Yetüt
- Diseases
- Type 2 diabetes
- NCT number
- NCT07921901
What you commit to
- Study type: Interventional
- Planned participants: 39
- From 1 Dec 2026 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 to 65 with type 2 diabetes. It compares two online home exercise programs with a control group.
- Age
- 40 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Type 2 diabetes diagnosed at least 1 year ago and medically stable. Pre-exercise blood glucose 90 to 250 mg/dL. HbA1c 6.5% to 11%.
- Earlier treatment
- Must use oral blood sugar medicine or insulin. Must not have taken part in an exercise program in the last six months.
- Biomarker or test result
- Blood glucose before exercise 90 to 250 mg/dL and HbA1c 6.5% to 11%.
Main reasons for not taking part
- Type 1 diabetes
- COPD, interstitial lung disease or asthma
- Coronary artery disease or uncontrolled high blood pressure
- Body mass index (BMI) of 35 kg/m² or more
- Pregnant or breastfeeding
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having participated in an exercise program within the previous six months.
Other illness
- Having type 1 diabetes mellitus.
- Having chronic obstructive pulmonary disease (COPD), interstitial lung disease, or asthma.
- Having coronary artery disease.
- Having neurological disorders.
- Having uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥120 mmHg).
- Having a thyroid disorder.
Other
- Having a body mass index (BMI) ≥35 kg/m².
- Having musculoskeletal problems that may prevent participation in exercise training.
- Being pregnant or breastfeeding.
- Having diabetic ulcers or peripheral neuropathy.
Who the study is looking for
- 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.
Age in the registry: 40 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| İstanbul University-Cerrahpaşa | Istanbul | Türkiye | Unknown status |
The registry text, word for word
This page is information, not medical advice. Discuss any trial with your doctor.