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Recruiting NCT07341711

Long-term Adaptations of Skeletal Muscle After Hybrid Training

No phase Interventional Obesity & Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise training, Control group.
Who it may be relevant to
Registry conditions: Obesity & Overweight. Basic parameters: 30 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Long-term Adaptations of Skeletal Muscle in Overweight and Obese Individuals After Hybrid Training

Overview

Obesity is a major challenge for public health and renders it imperative to reduce its prevalence. High intensity interval training (HIIT) is a form of exercise training that can efficiently induce weight loss in adults with overweight or obesity, even in the absence of dietary intake manipulation. Hybrid type training represents a form of HIIT, that incorporates both cardiorespiratory and musculoskeletal stimuli, by combining multiple types of exercise into a circuit-type, interval style workout. Recent evidence suggests that long-term participation in hybrid HIIT results in significant health-related benefits. However, the molecular mechanisms driving the chronic effects of hybrid HIIT on cardiometabolic and musculoskeletal health remains to be elucidated.

Detailed description

A total number of 30 adults (both males and females) aged 30-50, meeting the inclusion criteria, will be enrolled in this study. Participants will be randomly assigned to either (i) a Control group or (ii) an Intervention group. The Intervention group will participate in three hybrid-type HIIT sessions per week over a 6-month period while receiving a balanced diet. The Control group will receive a balanced diet over the 6-month period but will not participate in exercise training. At baseline and 6 months, both groups will undergo assessment of their anthropometric profile, body composition, resting metabolic rate, muscle strength and cardiorespiratory capacity and provide resting blood and skeletal muscle samples.

Interventions

  • Other Exercise training
    Participants will perform a six-month hybrid training program while receiving a balanced diet. The periodization of hybrid training intervention will consist of three 2-month phases of gradually increased exercise intensity and volume. In every training will participate 5-8 individuals. The training will contain 6-12 different exercises (stations), depending on the phase of the intervention, which will be executed in a circuit for a total of 2-3 rounds, with 2-3 minutes of rest period between se
  • Other Control group
    Participants will receive a balanced diet but will not participate in any type of exercise training over a six month period.

Primary outcome measures

  • Change in mitochondrial size [Time frame: At baseline and at 6 months]
  • Change in mitochondrial density [Time frame: At baseline and at 6 months]
  • Change in mitochondrial count [Time frame: At baseline and at 6 months]
  • Change in mitochondrial distribution [Time frame: At baseline and at 6 months]
  • Change in maximum oxygen consumption (VO2max) [Time frame: At baseline and at 6 months]
  • Change in muscle fiber cross-sectional area [Time frame: At baseline and at 6 months]
  • Change in PAX7+ satellite cells count [Time frame: At baseline and at 6 months]
  • Change in total protein content [Time frame: At baseline and at 6 months]
  • Change in myonuclei content [Time frame: At baseline and at 6 months]
  • Change in peroxisome proliferator-activated receptor-gamma coactivator -1a (PGC-1a) expression [Time frame: At baseline and at 6 months]
Secondary outcome measures (12)
  • Change in density and distribution of capillaries [Time frame: At baseline and at 6 months]
  • Change in skeletal muscle fiber typing [Time frame: At baseline and at 6 months]
  • Change in GLUT-4 protein expression [Time frame: At baseline and at 6 months]
  • Change reduced glutathione content in skeletal muscle cells [Time frame: At baseline and at 6 months]
  • Change in glutathione peroxidase activity in skeletal muscle cells [Time frame: At baseline and at 6 months]
  • Change in glutathione reductase activity in skeletal muscle cells [Time frame: At baseline and at 6 months]
  • Change in superoxide dismutase activity in skeletal muscle cells [Time frame: At baseline and at 6 months]
  • Change in fasting glucose levels [Time frame: At baseline and at 6 months]
  • Change in fasting insulin levels [Time frame: At baseline and at 6 months]
  • Change in glycosylated hemoglobin levels [Time frame: At baseline and at 6 months]
  • Change in high-density lipoprotein (HDL) levels [Time frame: At baseline and at 6 months]
  • Change in low-density lipoprotein (LDL) levels [Time frame: At baseline and at 6 months]

Eligibility criteria

Inclusion criteria

  • BMI: >25 kg/m2 and <40 kg/m2
  • Untrained individuals (abstain >1 year from exercise training)
  • No dietary intervention over the last 6 months preceding the study
  • Low cardiorespiratory fitness level (VO2max: <45 ml/kg/min)
  • No use of any medication, dietary supplements
  • Low risk for cardiovascular disease
  • A weight loss <10% over the last 6 months preceding the study
  • Free of non-communicable diseases (excluding metabolic syndrome)

Exclusion criteria

  • Low participation rate (<80% completion of the exercise training sessions)
  • Unbalanced diet
  • Participation in additional exercise training regimes
  • Cosumption of anti-inflammatory of pain relief medication

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Greece · 1 center
  • Department of Physical Education and Sport Science Trikala, University of Thessaly — Trikala

Identifiers

NCT: NCT07341711 · 2482/4.12.2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗