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Not yet recruiting NCT07494721

Effects of Training With a Pressure Cuff on Cellular Energy Activity

No phase Interventional Physical Deconditioning

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: Application of pressure cuffs during strength training, Application of pressure cuffs during endurance training, Conventional clinical rehabilitation program without the use of pressure cuffs.
Who it may be relevant to
Registry conditions: Physical Deconditioning. Basic parameters: from 18 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Influence of Short-Term Conventional Cuff-Assisted Training on Mitochondrial Capacity: A Non-Invasive Investigation

Overview

This study investigates low-load, cuff-assisted training to improve mitochondrial capacity. The intervention is carried out using automated pressure cuffs, applying an individualized pressure of 70% of the limb occlusion pressure. This approach reflects the current scientific consensus for safe and effective use in clinical populations. Within a rehabilitation setting, two training modalities are compared: intermittent strength training and alternating continuous endurance training. Muscle oxygen saturation is measured non-invasively using near-infrared spectroscopy.

Interventions

  • Diagnostic test Application of pressure cuffs during strength training
    Pre/Post comparison of mitochondrial capacity of the m. vastus lateralis muscle and muscle morphology between the groups.
  • Diagnostic test Application of pressure cuffs during endurance training
    Pre/Post comparison of mitochondrial capacity of the m. vastus lateralis muscle and muscle morphology between the groups
  • Diagnostic test Conventional clinical rehabilitation program without the use of pressure cuffs
    Pre/Post comparison of mitochondrial capacity of the m. vastus lateralis muscle and muscle morphology between the groups

Primary outcome measures

  • Determination of changes in the mitochondrial capacity of skeletal muscle (of the thigh muscle, vastus lateralis; measured non-invasively) [Time frame: From enrollment to the end of treatment at 6 weeks.]
Secondary outcome measures (3)
  • Minimum and maximum oxygen saturation (SmO₂) during application of pressure cuffs (measured via NIRS) [Time frame: From enrollment to the end of treatment at 6 weeks.]
  • Changes in total hemoglobin (tHb) as a measure of local blood volume (measured via NIRS) [Time frame: From enrollment to the end of treatment at 6 weeks.]
  • Assessment of subjective functional mobility using the "Lower Extremity Functional Scale" (LEFS) questionnaire [Time frame: From enrollment to the end of treatment at 6 weeks.]

Eligibility criteria

Inclusion:

  • Medically confirmed generalized deconditioning with reduced muscle strength
  • Medical certification of suitability for functional lower-extremity strength training
  • Written informed consent after an adequate reflection period

Exclusion:

  • Unstable arrhythmias, myocardial ischemia, symptomatic blood pressure drops or hypertension (>160/100 mmHg despite medication)
  • History of thrombosis or acute swelling/skin discoloration of the legs
  • Dizziness, confusion, cyanosis, or unexplained fatigue
  • Participant's wish to withdraw or not participate

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07494721 · 2026/STGAG_HB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗