Effects of Training With a Pressure Cuff on Cellular Energy Activity

March 26, 2026 updated by: Hannes Bossung, Spital Thurgau AG

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

51

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low-load strength training with intermittent application of pressure cuffs
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.
Active Comparator: Low-load endurance training with alternating continuous application of pressure cuffs
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
Placebo Comparator: Conventional clinical rehabilitation program without the use of pressure cuffs
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
From enrollment to the end of treatment at 6 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
Maximal Score: 80; Minimal Score: 0; Higher Score indicates better functional mobility
From enrollment to the end of treatment at 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spital Thurgau AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2026/STGAG_HB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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