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Periodization-Based Strength Exercise Training in İndividuals With Type 2 Diabetes (T2DM_NLP)

17. juni 2026 opdateret af: Neslihan Duruturk, Baskent University

A Comparison of the Effects of Different Periodization-Based Strength Training Programs in Individuals With Type 2 Diabetes Mellitus

This randomized controlled study aims to compare the effects of different periodization-based strength training approaches in individuals with type 2 diabetes mellitus. Participants will be allocated to non-linear periodization, linear periodization, or control groups. The intervention program will be conducted for 8 weeks and will evaluate exercise capacity, muscle strength, quality of life, body composition, and metabolic parameters.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Type 2 diabetes mellitus is associated with reduced exercise capacity, decreased muscle strength, impaired quality of life, and metabolic dysfunction. Exercise training is recommended as an important component of diabetes management; however, the comparative effectiveness of different strength training periodization approaches remains unclear.

This randomized controlled trial aims to compare the effects of non-linear periodization and linear periodization strength training programs in individuals with type 2 diabetes mellitus. Participants will be randomized into three groups: a non-linear periodization training group, a linear periodization training group, and a control group receiving usual care.

The intervention will be conducted for 8 weeks, three times per week. Outcomes including exercise capacity, muscle strength, body composition, quality of life, and metabolic parameters will be evaluated before and after the intervention period.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Ankara
      • Ankara, Ankara, Tyrkiet (Türkiye), 06790
        • Rekruttering
        • Baskent University Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Adults aged between 18 to 65 years
  • Diagnosis of Type 2 Diabetes Mellitus (T2DM)
  • Not having participated in any structured exercise program within the last 6 months
  • Willingness to participate in the study and provide written informed consent

Exclusion Criteria:

  • Presence of nephropathy, retinopathy, or peripheral neuropathy
  • Presence of neurological, cognitive, or orthopedic disorders that may affect outcome measurements
  • Severe respiratory disease (Forced Expiratory Volume in the first second [FEV1] <35% or Forced Vital Capacity [FVC] <50%)
  • Presence of ischemic heart disease or peripheral arterial disease
  • History of any cardiovascular event within the last 6 months
  • Current malignancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Non-linear Periodization Group
Participants will receive non-linear periodization-based strength training three times per week for 8 weeks.
Adfærdsmæssigt: Non-linear Periodization-Based Strength Training
Participants will perform supervised non-linear periodization-based strength training three times per week for 8 weeks.
Eksperimentel: Linear Periodization Group
Participants will receive linear periodization-based strength training three times per week for 8 weeks.
Adfærdsmæssigt: Linear Periodization-Based Strength Training
Participants will perform supervised linear periodization-based strength training three times per week for 8 weeks.
Aktiv komparator: Control Group
Participants will receive usual care and no structured exercise intervention during the study period.
Andet: Usual Care
Participants will receive usual care and no structured exercise intervention during the study period.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exercise Capacity
Tidsramme: Baseline and after 8 week
Exercise capacity will be assessed using the 6-Minute Walk Test (6MWT)
Baseline and after 8 week

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Peripheral Muscle Strength
Tidsramme: Baseline and after 8 weeks
Peripheral muscle strength will be assessed using handheld dynamometry for upper and lower extremity muscle groups and reported in Newton (N).
Baseline and after 8 weeks
Change in Hand Grip Strength
Tidsramme: Baseline and after 8 weeks
Hand grip strength will be assessed using a hand dynamometer and reported in kilograms (kg).
Baseline and after 8 weeks
Change in Diabetes Quality of Life Questionnaire Score
Tidsramme: Baseline and after 8 weeks
Change in the Turkish version of the Diabetes Quality of Life Questionnaire (DQOL) total score and subscale scores from baseline to 8 weeks will be evaluated. The DQOL consists of 45 items assessing treatment satisfaction, psychological impact, concerns about future effects of diabetes, and social/vocational concerns. Each item is scored on a 1-5 scale, and higher scores indicate better diabetes-related quality of life.
Baseline and after 8 weeks
Change in Body Fat Percentage
Tidsramme: Baseline and after 8 weeks
Body fat percentage (%) will be assessed using bioelectrical impedance analysis (BIA).
Baseline and after 8 weeks
Change in Skeletal Muscle Mass
Tidsramme: Baseline and after 8 weeks
Skeletal muscle mass (kg) will be assessed using bioelectrical impedance analysis (BIA).
Baseline and after 8 weeks
Change in Resting Metabolic Rate
Tidsramme: Baseline and after 8 weeks
Resting metabolic rate (kcal/day) will be assessed using indirect calorimetry (COSMED Fitmate Pro, Rome, Italy).
Baseline and after 8 weeks
Change in Hemoglobin A1c (HbA1c)
Tidsramme: Baseline and after 8 weeks
Glycemic control will be assessed by measuring glycated hemoglobin (HbA1c) levels (%).
Baseline and after 8 weeks
Change in Fasting Blood Glucose
Tidsramme: Baseline and after 8 weeks
Glycemic control will be assessed by measuring fasting blood glucose levels (mg/dL).
Baseline and after 8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Baskent University

Efterforskere

  • Ledende efterforsker: Neslihan Duruturk, PhD, Baskent University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2026

Primær færdiggørelse (Anslået)

1. november 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

6. juni 2026

Først indsendt, der opfyldte QC-kriterier

17. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • T2DM-NLP-2026

Plan for individuelle deltagerdata (IPD)

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