- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07291765
Blood Flow Restriction Training in Acute Geriatric Rehabilitation
May 11, 2026 updated by: Alexander Franz, University Hospital, Bonn
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexander Franz, Dr. med., B.Sc.
- Phone Number: +491703750718
- Email: alexander.franz@ukbonn.de
Study Locations
-
-
North Rhine-Westphalia
-
Cologne, North Rhine-Westphalia, Germany, 50668
- Recruiting
- St. Marien-Hospital Köln
-
Contact:
- Alexander Franz, Dr. med., B.Sc.
- Phone Number: +491703750718
- Email: alexander.franz@ukbonn.de
-
-
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
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults >65 years with a two week hospitalized acute rehabilitation after a fracture closed to the hip joint
Exclusion Criteria:
- Sickle Cell Anemia
- Iatrogenic changes of the vessels at the place of the tournqiuet application (e.g. Stents)
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Blood-Flow-Restriction Training
|
Cycling Intensity individualized + 60% LOP
|
|
Active Comparator: Control Group
Sham-Blood-Flow-Restriction Training
|
Cycling Intensity individualized + 20mmHg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Strength
Time Frame: Pre-Rehabilitation to Post-Rehabilitation (after 2 weeks)
|
Isometric Maximal Strength Test of the Knee Extensors (in kg)
|
Pre-Rehabilitation to Post-Rehabilitation (after 2 weeks)
|
|
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.
|
Pre-Rehabilitation to Post-Rehabilitation (after 2 Weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
January 1, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
March 31, 2027
Study Registration Dates
First Submitted
December 5, 2025
First Submitted That Met QC Criteria
December 5, 2025
First Posted (Actual)
December 18, 2025
Study Record Updates
Last Update Posted (Actual)
May 14, 2026
Last Update Submitted That Met QC Criteria
May 11, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2025_A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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