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NCT Number: NCT07494721

Effects of Training With a Pressure Cuff on Cellular Energy Activity

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.

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Key information

Conditions

Physical Deconditioning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

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

Sponsors and collaborators

Lead sponsor

Spital Thurgau AG

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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