Periodization-Based Strength Exercise Training in İndividuals With Type 2 Diabetes (T2DM_NLP)
17. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
48
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ayşegül Erkoç, PT
- Telefonnummer: +90 553-301-36-73
- E-post: erkcaysegl@gmail.com
Studiesteder
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Ankara
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Ankara, Ankara, Tyrkia (Türkiye), 06790
- Rekruttering
- Baskent University Hospital
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Ta kontakt med:
- Ayşegül Erkoç, PT
- Telefonnummer: +90 553-301-36-73
- E-post: erkcaysegl@gmail.com
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-
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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Non-linear Periodization Group
Participants will receive non-linear periodization-based strength training three times per week for 8 weeks.
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Participants will perform supervised non-linear periodization-based strength training three times per week for 8 weeks.
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Eksperimentell: Linear Periodization Group
Participants will receive linear periodization-based strength training three times per week for 8 weeks.
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Participants will perform supervised linear periodization-based strength training three times per week for 8 weeks.
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Aktiv komparator: Control Group
Participants will receive usual care and no structured exercise intervention during the study period.
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Participants will receive usual care and no structured exercise intervention during the study period.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Exercise Capacity
Tidsramme: Baseline and after 8 week
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Exercise capacity will be assessed using the 6-Minute Walk Test (6MWT)
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Baseline and after 8 week
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Peripheral Muscle Strength
Tidsramme: Baseline and after 8 weeks
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Peripheral muscle strength will be assessed using handheld dynamometry for upper and lower extremity muscle groups and reported in Newton (N).
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Baseline and after 8 weeks
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Change in Hand Grip Strength
Tidsramme: Baseline and after 8 weeks
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Hand grip strength will be assessed using a hand dynamometer and reported in kilograms (kg).
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Baseline and after 8 weeks
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Change in Diabetes Quality of Life Questionnaire Score
Tidsramme: Baseline and after 8 weeks
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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.
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Baseline and after 8 weeks
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Change in Body Fat Percentage
Tidsramme: Baseline and after 8 weeks
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Body fat percentage (%) will be assessed using bioelectrical impedance analysis (BIA).
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Baseline and after 8 weeks
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Change in Skeletal Muscle Mass
Tidsramme: Baseline and after 8 weeks
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Skeletal muscle mass (kg) will be assessed using bioelectrical impedance analysis (BIA).
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Baseline and after 8 weeks
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Change in Resting Metabolic Rate
Tidsramme: Baseline and after 8 weeks
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Resting metabolic rate (kcal/day) will be assessed using indirect calorimetry (COSMED Fitmate Pro, Rome, Italy).
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Baseline and after 8 weeks
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Change in Hemoglobin A1c (HbA1c)
Tidsramme: Baseline and after 8 weeks
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Glycemic control will be assessed by measuring glycated hemoglobin (HbA1c) levels (%).
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Baseline and after 8 weeks
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Change in Fasting Blood Glucose
Tidsramme: Baseline and after 8 weeks
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Glycemic control will be assessed by measuring fasting blood glucose levels (mg/dL).
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Baseline and after 8 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Neslihan Duruturk, PhD, Baskent University
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 (Faktiske)
1. mai 2026
Primær fullføring (Antatt)
1. november 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
6. juni 2026
Først innsendt som oppfylte QC-kriteriene
17. juni 2026
Først lagt ut (Faktiske)
22. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- T2DM-NLP-2026
Plan for individuelle deltakerdata (IPD)
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