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Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes

2. november 2026 oppdatert av: İrem Çaylak Yetüt

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

39

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Istanbul
      • Istanbul, Istanbul, Tyrkia (Türkiye), 34147
        • Istanbul University-Cerrahpasa
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • İrem Çaylak Yetüt, PhD student
        • Underetterforsker:
          • Gökşen Kuran Aslan, Professor
        • Underetterforsker:
          • Lütfullah Caştur, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Kombinert treningsgruppe

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.

Eksperimentell: Kontrollgruppe

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.

Eksperimentell: Funksjonell inspiratorisk muskeltreningsgruppe

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
six-minute walk distance
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Peripheral Muscle Strength Assessed by Handheld Dynamometry
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Lower Extremity Functional Performance Assessed by the 30-Second Sit-to-Stand Test
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: Gökşen Kuran Aslan, Proffessor, Istanbul University - Cerrahpasa
  • Studieleder: Lütfullah Caştur, MD, Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. desember 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

2. november 2026

Først innsendt som oppfylte QC-kriteriene

2. november 2026

Først lagt ut (Faktiske)

6. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

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Nei

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