Sarcopenia in ElderlyNCT07291765
Blood Flow Restriction Training in Acute Geriatric Rehabilitation
A study testing Stationary Bike + Blood-Flow-Restriction and Acute geriatric rehabilitation + No additional Intervention in people with Sarcopenia in Elderly, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Background: Older adults have a reduced ability to build and maintain muscle mass due to age-related changes in the muscular system. The resulting sarcopenia can lead to a number of health problems and limitations, such as an increased risk of falling and reduced mobility, which can affect quality of life and increase… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia in Elderly
- What is being tested?
- Stationary Bike + Blood-Flow-Restriction and Acute geriatric rehabilitation + No additional Intervention
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2026to 31 Mar 2027
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adults >65 years with a two week hospitalized acute rehabilitation after a fracture closed to the hip joint
Who cannot join
- Sickle Cell Anemia
- Iatrogenic changes of the vessels at the place of the tournqiuet application (e.g. Stents)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
St. Marien-Hospital Köln
Cologne, North Rhine-Westphalia, 50668
Alexander Franz, Dr. med., B.Sc., +491703750718, alexander.franz@ukbonn.de
About this study
Official title: Blood Flow Restriction Training in Acute Geriatric Rehabilitation: A Randomized Controlled Trial on Its Effects and Safety in Hospitalized Older Adults.
Background: Older adults have a reduced ability to build and maintain muscle mass due to age-related changes in the muscular system. The resulting sarcopenia can lead to a number of health problems and limitations, such as an increased risk of falling and reduced mobility, which can affect quality of life and increase the risk of disease. To increase muscle mass and strength, high-intensity resistance training with loads of 70 to 85% of the repetition maximum (1RM) is recommended. However, this type of training poses a major challenge in the rehabilitation sector, as there is also an increased risk of injury due to physical limitations in old age. According to current research, low-intensity occlusion training could therefore represent a safe and effective training alternative. The aim of this study is therefore to examine the feasibility and effects of blood flow restriction training (BFR) on general health in older adults in a rehabilitative setting.
Read the detailed description
The study is a randomized controlled trial with a pre-post design. Participants will be recruited from the of St. Marien Hospital Geriatric Rehabilitation Center in Cologne, Germany. Patients will be randomized into 2 groups. The intervention group will receive BRF training on a stationary cycling ergometer five times a week over a period of two weeks, while the control group will receive sham-BFR training.
- Conditions
- Sarcopenia in Elderly
- Being tested
- Stationary Bike + Blood-Flow-Restriction, Stationary Bike + Sham-Blood-Flow-Restriction, Acute geriatric rehabilitation + No additional Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stationary Bike + Blood-Flow-RestrictionDevice
Cycling Intensity individualized + 60% LOP
Stationary Bike + Sham-Blood-Flow-RestrictionDevice
Cycling Intensity individualized + 20mmHg
Acute geriatric rehabilitation + No additional InterventionProcedure or surgery
Acute geriatric rehabilitation + No additional intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Acute geriatric rehabilitation + Blood-Flow-Restriction Training Receives: Device: Stationary Bike + Blood-Flow-Restriction |
| Active Control Group | Active comparator | Acute geriatric rehabilitation + Sham-Blood-Flow-Restriction Training Receives: Device: Stationary Bike + Sham-Blood-Flow-Restriction |
| Passive Control Condition (Standard) | Active comparator | Acute geriatric rehabilitation/ Standard of Care Receives: Procedure: Acute geriatric rehabilitation + No additional Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Isometric Maximal Strength Test of the Knee Extensors (in kg)
Measured: Pre-Rehabilitation to Post-Rehabilitation (after 2 weeks)
Timed Up and Go Test
The Timed Up and Go Test (TUG) is a widely used English-language assessment for measuring functional mobility and fall risk in older adults. It records the time required to stand up from a chair, walk three meters, turn around, and sit down again.
Measured: Pre-Rehabilitation to Post-Rehabilitation (after 2 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Franz, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291765
- Sponsor's protocol ID
- 2025_A
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Training in Acute Geriatric Rehabilitation: A Randomized Controlled Trial on Its Effects and Safety in Hospitalized Older Adults.
- ClinicalTrials.gov ID
- NCT07291765
- Acronym / sponsor ID
- 2025_A
- Conditions
- Sarcopenia in Elderly
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 18 Dec 2025 (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.
Background: Older adults have a reduced ability to build and maintain muscle mass due to age-related changes in the muscular system. The resulting sarcopenia can lead to a number of health problems and limitations, such as an increased risk of falling and reduced mobility, which can affect quality of life and increase the risk of disease. To increase muscle mass and strength, high-intensity resistance training with loads of 70 to 85% of the repetition maximum (1RM) is recommended. However, this type of training poses a major challenge in the rehabilitation sector, as there is also an increased risk of injury due to physical limitations in old age. According to current research, low-intensity occlusion training could therefore represent a safe and effective training alternative. The aim of this study is therefore to examine the feasibility and effects of blood flow restriction training (BFR) on general health in older adults in a rehabilitative setting.
Detailed description
The study is a randomized controlled trial with a pre-post design. Participants will be recruited from the of St. Marien Hospital Geriatric Rehabilitation Center in Cologne, Germany. Patients will be randomized into 2 groups. The intervention group will receive BRF training on a stationary cycling ergometer five times a week over a period of two weeks, while the control group will receive sham-BFR training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Stationary Bike + Blood-Flow-RestrictionAcute geriatric rehabilitation + Blood-Flow-Restriction Training |
| Active Control Group | Active comparator | Device: Stationary Bike + Sham-Blood-Flow-RestrictionAcute geriatric rehabilitation + Sham-Blood-Flow-Restriction Training |
| Passive Control Condition (Standard) | Active comparator | Procedure: Acute geriatric rehabilitation + No additional InterventionAcute geriatric rehabilitation/ Standard of Care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Adults >65 years with a two week hospitalized acute rehabilitation after a fracture closed to the hip joint
Key exclusion criteria (2 listed)
- Sickle Cell Anemia
- Iatrogenic changes of the vessels at the place of the tournqiuet application (e.g. Stents)
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 |
|---|---|---|
| Stationary Bike + Blood-Flow-RestrictionCycling Intensity individualized + 60% LOP | Device | Intervention Group |
| Stationary Bike + Sham-Blood-Flow-RestrictionCycling Intensity individualized + 20mmHg | Device | Active Control Group |
| Acute geriatric rehabilitation + No additional InterventionAcute geriatric rehabilitation + No additional intervention | Procedure or surgery | Passive Control Condition (Standard) |
Primary outcome
Muscle Strength
Time frame: Pre-Rehabilitation to Post-Rehabilitation (after 2 weeks)
Isometric Maximal Strength Test of the Knee Extensors (in kg)
Timed Up and Go Test
Time frame: Pre-Rehabilitation to Post-Rehabilitation (after 2 Weeks)
The Timed Up and Go Test (TUG) is a widely used English-language assessment for measuring functional mobility and fall risk in older adults. It records the time required to stand up from a chair, walk three meters, turn around, and sit down again.
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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stationary Bike + Blood-Flow-Restriction and Acute geriatric rehabilitation + No additional Intervention in people with Sarcopenia in Elderly, run by University Hospital, Bonn at 1 site in Germany.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Alexander Franz, Dr. med., B.Sc. (+491703750718, alexander.franz@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength (time frame: Pre-Rehabilitation to Post-Rehabilitation (after 2 weeks)). The study lists 2 primary outcomes in all. 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 5 Oct 2026.