Healthy AgeingNCT07825987
Blood Flow Restriction Cycling for Functional Mobility in Older Adults
A study testing Individualized Blood Flow Restriction (BFR) via Personalized Tourniquet System in people with Healthy Ageing, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
This randomized, sham-controlled trial investigates whether a six-week, twice-weekly low-load cycling program combined with individualized blood flow restriction (BFR) improves functional mobility and health-related quality of life in community-dwelling adults older than 70 years, compared with identical cycling… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Healthy Ageing
- What is being tested?
- Individualized Blood Flow Restriction (BFR) via Personalized Tourniquet System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age > 70 years
- Community-dwelling
- Written informed consent
- Medical clearance for participation in exercise training with blood flow restriction (BFR)
Who cannot join
- Acute or chronic malignancy
- Immunosuppression
- Acute or chronic systemic infection
- Sickle cell anemia
- Previous vascular surgery of the lower extremities (e.g., bypass grafting or stent implantation)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Cellitinnen-Krankenhaus St. Marien
Cologne, North Rhine-Westphalia, 50668
About this study
Official title: Effects of Individualized Blood Flow Restriction During Low-Load Cycling Training on Functional Mobility and Quality of Life in Community-Dwelling Older Adults
This randomized, sham-controlled trial investigates whether a six-week, twice-weekly low-load cycling program combined with individualized blood flow restriction (BFR) improves functional mobility and health-related quality of life in community-dwelling adults older than 70 years, compared with identical cycling exercise without effective BFR. Blood flow restriction is applied using thigh cuffs, individually calibrated to a percentage of each participant's measured limb occlusion pressure; the control group receives cycling exercise with a fixed, low sham cuff pressure. The co-primary outcomes are functional mobility, assessed using the De Morton Mobility Index (DEMMI), and health-related quality of life, assessed using the SF-36 questionnaire. Secondary outcomes include the Timed Up and Go test, the Six-Minute Walk Test, muscular strength, body composition, endurance capacity, and cardiovascular and metabolic safety parameters.
- Conditions
- Healthy Ageing
- Being tested
- Individualized Blood Flow Restriction (BFR) via Personalized Tourniquet System, Sham Blood Flow Restriction (Fixed Low Pressure)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Blood Flow Restriction (BFR) via Personalized Tourniquet SystemDevice
Bilateral thigh cuffs (Personalized Tourniquet System, Delfi Medical Innovations Inc., Vancouver, Canada) applied during cycling exercise, pressure individually calibrated to 60% of measured limb occlusion pressure.
Sham Blood Flow Restriction (Fixed Low Pressure)Device
Bilateral thigh cuffs applied identically to the intervention arm, using the same device, but set to a fixed, non-occlusive pressure of 20 mmHg rather than an individually calibrated pressure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (INT) | Experimental | Participants performed 15-minute, twice-weekly low-load cycling sessions for six weeks (12 sessions total), combined with bilateral blood flow restriction using thigh cuffs individually calibrated to 60% of each participant's measured limb occlusion pressure (LOP). Exercise intensity was prescribed as an internal training load, individually matched to a target relative heart rate (percentage of heart rate reserve), with workload adjusted session-to-session as needed. Receives: Device: Individualized Blood Flow Restriction (BFR) via Personalized Tourniquet System |
| Sham Comparator (CON) | Active comparator | Participants performed the identical 15-minute, twice-weekly low-load cycling protocol for six weeks (12 sessions total), with bilateral thigh cuffs applied at a fixed, non-occlusive sham pressure of 20 mmHg. Exercise intensity was prescribed identically to the intervention arm (internal training load, individually matched to target heart rate reserve) Receives: Device: Sham Blood Flow Restriction (Fixed Low Pressure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Mobility (De Morton Mobility Index, DEMMI)
Change in DEMMI interval score (range 0-100, Rasch-converted), assessed by a blinded rater.
Measured: Baseline (T0) to post-intervention (T1, 48-72 hours after the last of 12 training sessions, approx. 6 weeks)
Change in Health-Related Quality of Life (SF-36)
Change across the eight domains and summary scores of the SF-36 (German version), analyzed jointly as a single co-primary outcome family.
Measured: Baseline (T0) to post-intervention (T1, approx. 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Jan 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AgeingStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
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
- NCT07825987
- Sponsor's protocol ID
- 2023_H
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Franz A, Schroeder S, Ji S, Froschen FS, Schulz RJ, Wahl P. Effects of individualized blood flow restriction during brief twice-weekly low-load cycling on mobility and muscle function in adults older than 70 years. Front Sports Act Living. 2026 Oct 2;8:1933001. doi: 10.3389/fspor.2026.1933001. eCollection 2026.
PubMed 42890927
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Individualized Blood Flow Restriction During Low-Load Cycling Training on Functional Mobility and Quality of Life in Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT07825987
- Acronym / sponsor ID
- 2023_H
- Conditions
- Healthy Ageing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 17 Sep 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 randomized, sham-controlled trial investigates whether a six-week, twice-weekly low-load cycling program combined with individualized blood flow restriction (BFR) improves functional mobility and health-related quality of life in community-dwelling adults older than 70 years, compared with identical cycling exercise without effective BFR. Blood flow restriction is applied using thigh cuffs, individually calibrated to a percentage of each participant's measured limb occlusion pressure; the control group receives cycling exercise with a fixed, low sham cuff pressure. The co-primary outcomes are functional mobility, assessed using the De Morton Mobility Index (DEMMI), and health-related quality of life, assessed using the SF-36 questionnaire. Secondary outcomes include the Timed Up and Go test, the Six-Minute Walk Test, muscular strength, body composition, endurance capacity, and cardiovascular and metabolic safety parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (INT) | Experimental | Device: Individualized Blood Flow Restriction (BFR) via Personalized Tourniquet SystemParticipants performed 15-minute, twice-weekly low-load cycling sessions for six weeks (12 sessions total), combined with bilateral blood flow restriction using thigh cuffs individually calibrated to 60% of each participant's measured limb occlusion pressure (LOP). Exercise intensity was prescribed as an internal training load, individually matched to a target relative heart rate (percentage of heart rate reserve), with workload adjusted session-to-session as needed. |
| Sham Comparator (CON) | Active comparator | Device: Sham Blood Flow Restriction (Fixed Low Pressure)Participants performed the identical 15-minute, twice-weekly low-load cycling protocol for six weeks (12 sessions total), with bilateral thigh cuffs applied at a fixed, non-occlusive sham pressure of 20 mmHg. Exercise intensity was prescribed identically to the intervention arm (internal training load, individually matched to target heart rate reserve) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age > 70 years
- Community-dwelling
- Written informed consent
- Medical clearance for participation in exercise training with blood flow restriction (BFR)
Key exclusion criteria (5 listed)
- Acute or chronic malignancy
- Immunosuppression
- Acute or chronic systemic infection
- Sickle cell anemia
- Previous vascular surgery of the lower extremities (e.g., bypass grafting or stent implantation)
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 |
|---|---|---|
| Individualized Blood Flow Restriction (BFR) via Personalized Tourniquet SystemBilateral thigh cuffs (Personalized Tourniquet System, Delfi Medical Innovations Inc., Vancouver, Canada) applied during cycling exercise, pressure individually calibrated to 60% of measured limb occlusion pressure. | Device | Intervention Group (INT) |
| Sham Blood Flow Restriction (Fixed Low Pressure)Bilateral thigh cuffs applied identically to the intervention arm, using the same device, but set to a fixed, non-occlusive pressure of 20 mmHg rather than an individually calibrated pressure. | Device | Sham Comparator (CON) |
Primary outcome
Change in Functional Mobility (De Morton Mobility Index, DEMMI)
Time frame: Baseline (T0) to post-intervention (T1, 48-72 hours after the last of 12 training sessions, approx. 6 weeks)
Change in DEMMI interval score (range 0-100, Rasch-converted), assessed by a blinded rater.
Change in Health-Related Quality of Life (SF-36)
Time frame: Baseline (T0) to post-intervention (T1, approx. 6 weeks)
Change across the eight domains and summary scores of the SF-36 (German version), analyzed jointly as a single co-primary outcome family.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 42890927Franz A, Schroeder S, Ji S, Froschen FS, Schulz RJ, Wahl P. Effects of individualized blood flow restriction during brief twice-weekly low-load cycling on mobility and muscle function in adults older than 70 years. Front Sports Act Living. 2026 Oct 2;8:1933001. doi: 10.3389/fspor.2026.1933001. eCollection 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Blood Flow Restriction (BFR) via Personalized Tourniquet System in people with Healthy Ageing, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 17 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Functional Mobility (De Morton Mobility Index, DEMMI) (time frame: Baseline (T0) to post-intervention (T1, 48-72 hours after the last of 12 training sessions, approx. 6 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?
On the ClinicalTrials.gov record for NCT07825987, which also lists 1 linked publication.
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 17 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.