Health TrialsbyHealthPanel

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

ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBaskent University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Non-linear Periodization-Based Strength Training

    Behavioral

    Participants will perform supervised non-linear periodization-based strength training three times per week for 8 weeks.

  • Linear Periodization-Based Strength Training

    Behavioral

    Participants will perform supervised linear periodization-based strength training three times per week for 8 weeks.

  • Usual Care

    Other intervention

    Participants will receive usual care and no structured exercise intervention during the study period.

Treatment groups

48 Participants
are divided into 3 treatment groups
Group A: Non-linear Periodization GroupExperimental treatment 1 intervention
Group B: Linear Periodization GroupExperimental treatment 1 intervention
Group C: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Exercise Capacity

Exercise capacity will be assessed using the 6-Minute Walk Test (6MWT)

Time frame
Baseline and after 8 week

Secondary outcomes

1

Change in Peripheral Muscle Strength

Peripheral muscle strength will be assessed using handheld dynamometry for upper and lower extremity muscle groups and reported in Newton (N).

Time frame
Baseline and after 8 weeks
2

Change in Hand Grip Strength

Hand grip strength will be assessed using a hand dynamometer and reported in kilograms (kg).

Time frame
Baseline and after 8 weeks
3

Change in Diabetes Quality of Life Questionnaire Score

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.

Time frame
Baseline and after 8 weeks
4

Change in Body Fat Percentage

Body fat percentage (%) will be assessed using bioelectrical impedance analysis (BIA).

Time frame
Baseline and after 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baskent University

Lead sponsor

Source ClinicalTrials.gov
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