Periodization-Based Strength Exercise Training in İndividuals With Type 2 Diabetes (T2DM_NLP)
17 juni 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
48
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Ayşegül Erkoç, PT
- Telefonnummer: +90 553-301-36-73
- E-post: erkcaysegl@gmail.com
Studieorter
-
-
Ankara
-
Ankara, Ankara, Turkiet (Türkiye), 06790
- Rekrytering
- Baskent University Hospital
-
Kontakt:
- Ayşegül Erkoç, PT
- Telefonnummer: +90 553-301-36-73
- E-post: erkcaysegl@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Non-linear Periodization Group
Participants will receive non-linear periodization-based strength training three times per week for 8 weeks.
|
Participants will perform supervised non-linear periodization-based strength training three times per week for 8 weeks.
|
|
Experimentell: Linear Periodization Group
Participants will receive linear periodization-based strength training three times per week for 8 weeks.
|
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.
|
Participants will receive usual care and no structured exercise intervention during the study period.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Exercise Capacity
Tidsram: Baseline and after 8 week
|
Exercise capacity will be assessed using the 6-Minute Walk Test (6MWT)
|
Baseline and after 8 week
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Peripheral Muscle Strength
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: Baseline and after 8 weeks
|
Glycemic control will be assessed by measuring fasting blood glucose levels (mg/dL).
|
Baseline and after 8 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Neslihan Duruturk, PhD, Baskent University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 maj 2026
Primärt slutförande (Beräknad)
1 november 2026
Avslutad studie (Beräknad)
1 december 2026
Studieregistreringsdatum
Först inskickad
6 juni 2026
Först inskickad som uppfyllde QC-kriterierna
17 juni 2026
Första postat (Faktisk)
22 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- T2DM-NLP-2026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .