Physical DeconditioningNCT07494721
Effects of Training With a Pressure Cuff on Cellular Energy Activity
A study testing Application of pressure cuffs during strength training, Application of pressure cuffs during endurance training and Conventional clinical rehabilitation program without the use of pressure cuffs in people with Physical Deconditioning, run by Spital Thurgau AG.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Deconditioning
- What is being tested?
- Application of pressure cuffs during strength training, Application of pressure cuffs during endurance training and Conventional clinical rehabilitation program without the use of pressure cuffs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Physical Deconditioning
- Being tested
- Application of pressure cuffs during strength training, Application of pressure cuffs during endurance training, Conventional clinical rehabilitation program without the use of pressure cuffs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of pressure cuffs during strength trainingDiagnostic 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 trainingDiagnostic 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 cuffsDiagnostic test
Pre/Post comparison of mitochondrial capacity of the m. vastus lateralis muscle and muscle morphology between the groups
| Study group | Role | What they receive |
|---|---|---|
| Low-load strength training with intermittent application of pressure cuffs | Active comparator | Not described Receives: Diagnostic Test: Application of pressure cuffs during strength training |
| Low-load endurance training with alternating continuous application of pressure cuffs | Active comparator | Not described Receives: Diagnostic Test: Application of pressure cuffs during endurance training |
| Conventional clinical rehabilitation program without the use of pressure cuffs | Placebo comparator | Not described Receives: Diagnostic Test: Conventional clinical rehabilitation program without the use of pressure cuffs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of changes in the mitochondrial capacity of skeletal muscle (of the thigh muscle, vastus lateralis; measured non-invasively)
Measured: From enrollment to the end of treatment at 6 weeks.
Secondary outcomes (3)
Minimum and maximum oxygen saturation (SmO₂) during application of pressure cuffs (measured via NIRS)
Measured: 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)
Measured: From enrollment to the end of treatment at 6 weeks.
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
Measured: From enrollment to the end of treatment at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DeconditioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spital Thurgau AG
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannes Bossung, Spital Thurgau AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494721
- Sponsor's protocol ID
- 2026/STGAG_HB
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Short-Term Conventional Cuff-Assisted Training on Mitochondrial Capacity: A Non-Invasive Investigation
- ClinicalTrials.gov ID
- NCT07494721
- Acronym / sponsor ID
- 2026/STGAG_HB
- Conditions
- Physical Deconditioning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Spital Thurgau AGUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-load strength training with intermittent application of pressure cuffs | Active comparator | Diagnostic Test: Application of pressure cuffs during strength training |
| Low-load endurance training with alternating continuous application of pressure cuffs | Active comparator | Diagnostic Test: Application of pressure cuffs during endurance training |
| Conventional clinical rehabilitation program without the use of pressure cuffs | Placebo comparator | Diagnostic Test: Conventional clinical rehabilitation program without the use of pressure cuffs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of pressure cuffs during strength trainingPre/Post comparison of mitochondrial capacity of the m. vastus lateralis muscle and muscle morphology between the groups. | Diagnostic test | Low-load strength training with intermittent application of pressure cuffs |
| Application of pressure cuffs during endurance trainingPre/Post comparison of mitochondrial capacity of the m. vastus lateralis muscle and muscle morphology between the groups | Diagnostic test | Low-load endurance training with alternating continuous application of pressure cuffs |
| Conventional clinical rehabilitation program without the use of pressure cuffsPre/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 |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Application of pressure cuffs during strength training, Application of pressure cuffs during endurance training and Conventional clinical rehabilitation program without the use of pressure cuffs in people with Physical Deconditioning, run by Spital Thurgau AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.