- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07921901
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
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.
A tanulmány áttekintése
Állapot
Körülmények
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: İrem Çaylak Yetüt, PhD Student
- Telefonszám: +905397685616
- E-mail: iremcaylakyetut@ogr.iuc.edu.tr
Tanulmányi helyek
-
-
Istanbul
-
Istanbul, Istanbul, Törökország (Türkiye), 34147
- Istanbul University-Cerrahpasa
-
Kapcsolatba lépni:
- İrem Çaylak Yetüt, PhD student
- Telefonszám: +905397685616
- E-mail: iremcaylakyetut@ogr.iuc.edu.tr
-
Kapcsolatba lépni:
- Gökşen Kuran Aslan, Proffessor
- E-mail: goksen.kuranaslan@iuc.edu.tr
-
Kutatásvezető:
- İrem Çaylak Yetüt, PhD student
-
Alkutató:
- Gökşen Kuran Aslan, Professor
-
Alkutató:
- Lütfullah Caştur, MD
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Összevont gyakorlatképző csoport
|
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. |
|
Kísérleti: Ellenőrző csoport
|
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. |
|
Kísérleti: Funkcionális belégzési izmok tréning csoport
|
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. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
six-minute walk distance
Időkeret: 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. |
baseline and week 8
|
|
Fatigue Level Assessed by FACİT-Fatigue Scale
Időkeret: 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. |
Baseline and week 8
|
|
Dynamic Balance Assessed by Timed Up and Go Test (TUG)
Időkeret: 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. |
Baseline and week 8
|
|
Balance Confidence Assessed by Activities-specific Balance Confidence Scale (ABC)
Időkeret: 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. |
Baseline and week 8
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Peripheral Muscle Strength Assessed by Handheld Dynamometry
Időkeret: Baseline and week 8
|
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. |
Baseline and week 8
|
|
Maximal Expiratory Pressure
Időkeret: Baseline and week 8
|
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. |
Baseline and week 8
|
|
Diabetes-Related Quality of Life Assessed by DQoL-BCI
Időkeret: Baseline and week 8
|
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. |
Baseline and week 8
|
|
Instrumental Activities of Daily Living Assessed by Lawton-Brody Scale
Időkeret: Baseline and week 8
|
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. |
Baseline and week 8
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Lower Extremity Functional Performance Assessed by the 30-Second Sit-to-Stand Test
Időkeret: Baseline and week 8
|
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. |
Baseline and week 8
|
|
Waist Circumference
Időkeret: Baseline and week 8
|
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. |
Baseline and week 8
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi szék: Gökşen Kuran Aslan, Proffessor, Istanbul University - Cerrahpasa
- Tanulmányi igazgató: Lütfullah Caştur, MD, Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- IUC-T2DM-IMT-2026
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .