Effects of Training With a Pressure Cuff on Cellular Energy Activity

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSpital Thurgau AG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Unstable arrhythmias, myocardial ischemia, symptomatic blood pressure drops or hypertension (>160/100 mmHg despite medication)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Application of pressure cuffs during strength training

    Diagnostic test

    Pre/Post comparison of mitochondrial capacity of the m. vastus lateralis muscle and muscle morphology between the groups.

  • Application of pressure cuffs during endurance training

    Diagnostic test

    Pre/Post comparison of mitochondrial capacity of the m. vastus lateralis muscle and muscle morphology between the groups

  • Conventional clinical rehabilitation program without the use of pressure cuffs

    Diagnostic test

    Pre/Post comparison of mitochondrial capacity of the m. vastus lateralis muscle and muscle morphology between the groups

Treatment groups

51 Participants
are divided into 3 treatment groups
Group A: Low-load strength training with intermittent application of pressure cuffsActive comparator 1 intervention
Group B: Low-load endurance training with alternating continuous application of pressure cuffsActive comparator 1 intervention
Group C: Conventional clinical rehabilitation program without the use of pressure cuffsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

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.
2

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.
3

Assessment of subjective functional mobility using the "Lower Extremity Functional Scale" (LEFS) questionnaire

Maximal Score: 80; Minimal Score: 0; Higher Score indicates better functional mobility

Time frame
From enrollment to the end of treatment at 6 weeks.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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