Older AdultsBiPerAgeNCT06453473
Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills
A study testing TSBR and PerTSBR in people with Older Adults and Exercise Training, run by University of Erlangen-Nürnberg Medical School at 2 sites in 2 countries.
Trial summary
The Israeli research group of this trial has developed the Perturbation Stationary Bicycle Robotics (PerStBiRo) system that can challenge balance while sitting. With this system, unexpected perturbations can be provided under controlled and safe conditions. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults, Exercise Training, Bicycling
- What is being tested?
- TSBR and PerTSBR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Mar 2025to 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Ability and willingness to provide informed consent and accept randomization to either study arm
- Ability to come to cycle course testing locations
- ≥3 errors in pre-test of cycle course
Who cannot join
- Severe diseases e.g. ischemic heart disease which restricts exercise, chronic obstructive pulmonary disease (COPD), uncontrolled blood pressure, manifest osteoporosis or any other disease leading to increased fracture risks
- A period less than one year after hip or knee replacement surgery or after fractures of the lower extremities
- Amputation of a lower limb
- Neurological diseases or 6-month after a stroke
- Inability to ambulate independently
- Severe visual impairments (blindness), non-compensable hearing
- Cognitive impairment, scoring less than 24 on the MMSE (Mini-Mental State Examination), inability to understand and follow instructions
- Participation in another intervention trial at the same time or within the previous 6 months
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
Friedrich-Alexander-Universität Erlangen-Nürnberg, Institut für Biomedizin des Alterns
Nuremberg, Bavaria, 90408
Robert Kob, PhD, +49 911 5302 96624, robert.kob@fau.de
Sebastian Krumpoch, PhD, +49 911 5302 96176, sebastian.krumpoch@fau.de
Israel1 site, 1 recruiting
- Recruiting
Physical Therapy department, faculty of health sciences, Ben-Gurion University of the Negev
Beersheba, 8410501
Itshak Melzer, PhD, P.T., +972 8 6479521, itzikm@bgu.ac.il
About this study
Official title: The Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills and Behavior (BiPerAge): a Single Blind Randomized Controlled Trial
The Israeli research group of this trial has developed the Perturbation Stationary Bicycle Robotics (PerStBiRo) system that can challenge balance while sitting. With this system, unexpected perturbations can be provided under controlled and safe conditions. Within the BiPerAge-project it will be evaluated if 20 training sessions (20 minutes each) on the PerStBiRo system will lead to transfer effects on safe cycling skills of community-dwelling older adults (age 65 years and older). The ability to cycle safely will be tested prior and after the training period using a cycling course, which consists of variant tasks requiring motor and cognitive skills.
Read the detailed description
Cycling is a form of physical activity that is positively associated with health and functional benefits. However, there is a significant association between increased bicycle use and bicycle accidents with higher risks of severe injuries especially for older adults. This could be partly explained by deterioration of the balance control during aging. On the one hand, training of balance-challenging situations in daily traffic situation is hardly possible under "real-world" conditions for safety reasons. On the other hand, the use of a stationary bicycle alone has not been shown to specifically train balance skills and cycling competence. To overcome this issue the Israeli research group of this trial has developed the Perturbation Stationary Bicycle Robotics (PerStBiRo) system that can challenge balance while riding in a controlled and safe condition.
The main and overarching objective of our proposed project is to investigate transfer effects of a training on the PerStBiRo system with perturbation (PerTSBR - intervention group) on cycling competence of community-dwelling older adults (age 65 years and older) in comparison to a training on the same system without perturbation (TSBR - active control group). The cycling competence as our primary outcome will be measured by a standardized cycle course before and after the 3 months intervention period. The cycle course, which is validated in a recent study (SiFAr) of our research group, consists of various tasks requiring motor and cognitive skills related to traffic situations in daily life.
- Conditions
- Older Adults, Exercise Training, Bicycling
- Being tested
- TSBR, PerTSBR
- Keywords
- Bicycling, Perturbation, Balance control, Falls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSBROther
The intervention consists of 20 training sessions on the PerStBiRo system (~ twice a week within 3 months period). Each session lasts for 20 minutes and includes three parts: stage 1) warm up, stage 2) main exercise and stage 3) cool down.
Stage 1 contains 3 minutes of self-paced pedalling with the same bicycle resistance. At Stage 2, the main exercise, all participants will perform a 15-minute hands-free cycling training on the PerStBiRo system with a pulse watch to maintain moderate-intensity training, corresponding to 64-76% of the predicted maximal heart rate (Borg scale 12-14), including cognitive tasks projected at a screen in front of the participant. Stage 3 includes the cool down with 2 minutes of self-paced pedalling without bicycle resistance and cognitive tasks. During the training sessions, all participants will wear a loose safety harness that can arrest falling using the PerStBiRo system, but still allow comfortable pedalling.
PerTSBROther
Participants of the intervention group will receive a combination of lateral and medial tilting unannounced perturbations during stage 2 of the TSBR training. This will be provided by roll and pitch angles (tilt) balance perturbations that aim to evoke trunk and arm balance recovery responses.
| Study group | Role | What they receive |
|---|---|---|
| training on the PerStBiRo with pertubation (PerTSBR) | Experimental | The experimental group will pedall on the PerStBiRo system like the active comparator group but will receive additional roll- and pitch-angles balance perturbations. Receives: Other: TSBR; Other: PerTSBR |
| unperturbed training on the PerStBiRo (TSBR) | Active comparator | The active comparator group will pedall on the PerStBiRo system without perturbations. Receives: Other: TSBR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of faults in the cycling course
The cycling competence will be tested in a standardized cycling course, including the following tasks: slalom, slow cycling within a marked lane, dismounting into a marked zone, getting on the bike, cycling through a narrow alley, turning to the off-side, braking with pinpoint accuracy. Mean change of number of faults in the cycling course will be tested between pre- and postintervention.
Measured: changes over a period of 3 months and after a follow-up period of 6-9 months
Secondary outcomes (3)
Balance Error Scoring System (BESS)
mean change in sumscore counting the errors, or deviations from the proper stance (0-30 error points) for measurement of static balance, higher error points indicate worse balance
Measured: changes over a period of 3 months and after a follow-up period of 6-9 months
5 Chair Stand Test
mean change of time in seconds for measurement of muscle power of the legs
Measured: changes over a period of 3 months and after a follow-up period of 6-9 months
Four Square Step Test
mean change of time in seconds for measurement of dynamic balance
Measured: changes over a period of 3 months and after a follow-up period of 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start12 Mar 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
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 Older AdultsStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- BiPerAge is a parallel group (1:1), randomized controlled trial with a duration of 3 years and a recruitment period between September 2024 and December 2025. Baseline data collection (T0) takes place in-person in the study center and in the cycle course on two different days within approximately 14 days. Except for cognitive function, same data are collected of all participants after the 3 months intervention period (T1), regardless of their compliance. In addition, participants will be followed up 6-9 months after T1 (T2) related to seasonal time frames (after winter season).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Sponsor
- Investigators
- Robert Kob, PhD, Principal investigator, Institute for Biomedicine of Aging, Friederich-Alexander-Universität Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453473
- Sponsor's protocol ID
- BGU-IBA-2024-BiPerAge
- Acronym
- BiPerAge
- Status last verified
- Aug 2025
- First submitted
- 5 Jun 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data relative to this work will be available upon reasonable request to the principal investigators.
Publications
Rogler J, Krumpoch S, Freiberger E, Margalit N, Zehavi R, Melzer I, Barak S, Shapiro A, Amir DJ, Levi S, Lubovsky O, Kob R. Outdoor cycling competence and balance control in older adults - cross-sectional analysis of the BiPerAge trial. BMC Geriatr. 2026 Oct 19;26(1):1306. doi: 10.1186/s12877-026-08491-7.
PubMed 42897509
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills and Behavior (BiPerAge): a Single Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06453473
- Acronym / sponsor ID
- BiPerAge / BGU-IBA-2024-BiPerAge
- Conditions
- Older Adults, Exercise Training, Bicycling
- Keywords
- Bicycling, Perturbation, Balance control, Falls
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 11 Jun 2024 (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.
The Israeli research group of this trial has developed the Perturbation Stationary Bicycle Robotics (PerStBiRo) system that can challenge balance while sitting. With this system, unexpected perturbations can be provided under controlled and safe conditions. Within the BiPerAge-project it will be evaluated if 20 training sessions (20 minutes each) on the PerStBiRo system will lead to transfer effects on safe cycling skills of community-dwelling older adults (age 65 years and older). The ability to cycle safely will be tested prior and after the training period using a cycling course, which consists of variant tasks requiring motor and cognitive skills.
Detailed description
Cycling is a form of physical activity that is positively associated with health and functional benefits. However, there is a significant association between increased bicycle use and bicycle accidents with higher risks of severe injuries especially for older adults. This could be partly explained by deterioration of the balance control during aging. On the one hand, training of balance-challenging situations in daily traffic situation is hardly possible under "real-world" conditions for safety reasons. On the other hand, the use of a stationary bicycle alone has not been shown to specifically train balance skills and cycling competence. To overcome this issue the Israeli research group of this trial has developed the Perturbation Stationary Bicycle Robotics (PerStBiRo) system that can challenge balance while riding in a controlled and safe condition.
The main and overarching objective of our proposed project is to investigate transfer effects of a training on the PerStBiRo system with perturbation (PerTSBR - intervention group) on cycling competence of community-dwelling older adults (age 65 years and older) in comparison to a training on the same system without perturbation (TSBR - active control group). The cycling competence as our primary outcome will be measured by a standardized cycle course before and after the 3 months intervention period. The cycle course, which is validated in a recent study (SiFAr) of our research group, consists of various tasks requiring motor and cognitive skills related to traffic situations in daily life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- BiPerAge is a parallel group (1:1), randomized controlled trial with a duration of 3 years and a recruitment period between September 2024 and December 2025. Baseline data collection (T0) takes place in-person in the study center and in the cycle course on two different days within approximately 14 days. Except for cognitive function, same data are collected of all participants after the 3 months intervention period (T1), regardless of their compliance. In addition, participants will be followed up 6-9 months after T1 (T2) related to seasonal time frames (after winter season).
| Arm | Type | Receives |
|---|---|---|
| training on the PerStBiRo with pertubation (PerTSBR) | Experimental | Other: TSBR, Other: PerTSBRThe experimental group will pedall on the PerStBiRo system like the active comparator group but will receive additional roll- and pitch-angles balance perturbations. |
| unperturbed training on the PerStBiRo (TSBR) | Active comparator | Other: TSBRThe active comparator group will pedall on the PerStBiRo system without perturbations. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Ability and willingness to provide informed consent and accept randomization to either study arm
- Ability to come to cycle course testing locations
- ≥3 errors in pre-test of cycle course
Key exclusion criteria (8 listed)
- Severe diseases e.g. ischemic heart disease which restricts exercise, chronic obstructive pulmonary disease (COPD), uncontrolled blood pressure, manifest osteoporosis or any other disease leading to increased fracture risks
- A period less than one year after hip or knee replacement surgery or after fractures of the lower extremities
- Amputation of a lower limb
- Neurological diseases or 6-month after a stroke
- Inability to ambulate independently
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 |
|---|---|---|
| TSBRThe intervention consists of 20 training sessions on the PerStBiRo system (~ twice a week within 3 months period). Each session lasts for 20 minutes and includes three parts: stage 1) warm up, stage 2) main exercise and stage 3) cool down. Stage 1 contains 3 minutes of self-paced pedalling with the same bicycle resistance. At Stage 2, the main exercise, all participants will perform a 15-minute hands-free cycling training on the PerStBiRo system with a pulse watch to maintain moderate-intensity training, corresponding to 64-76% of the predicted maximal heart rate (Borg scale 12-14), including cognitive tasks projected at a screen in front of the participant. Stage 3 includes the cool down with 2 minutes of self-paced pedalling without bicycle resistance and cognitive tasks. During the training sessions, all participants will wear a loose safety harness that can arrest falling using the PerStBiRo system, but still allow comfortable pedalling. | Other | training on the PerStBiRo with pertubation (PerTSBR), unperturbed training on the PerStBiRo (TSBR) |
| PerTSBRParticipants of the intervention group will receive a combination of lateral and medial tilting unannounced perturbations during stage 2 of the TSBR training. This will be provided by roll and pitch angles (tilt) balance perturbations that aim to evoke trunk and arm balance recovery responses. | Other | training on the PerStBiRo with pertubation (PerTSBR) |
Primary outcome
Number of faults in the cycling course
Time frame: changes over a period of 3 months and after a follow-up period of 6-9 months
The cycling competence will be tested in a standardized cycling course, including the following tasks: slalom, slow cycling within a marked lane, dismounting into a marked zone, getting on the bike, cycling through a narrow alley, turning to the off-side, braking with pinpoint accuracy. Mean change of number of faults in the cycling course will be tested between pre- and postintervention.
3 secondary outcomes
Balance Error Scoring System (BESS)
Time frame: changes over a period of 3 months and after a follow-up period of 6-9 months
5 Chair Stand Test
Time frame: changes over a period of 3 months and after a follow-up period of 6-9 months
Four Square Step Test
Time frame: changes over a period of 3 months and after a follow-up period of 6-9 months
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 16 Sep 2025.
- Derived from this study: PubMed 42897509Rogler J, Krumpoch S, Freiberger E, Margalit N, Zehavi R, Melzer I, Barak S, Shapiro A, Amir DJ, Levi S, Lubovsky O, Kob R. Outdoor cycling competence and balance control in older adults - cross-sectional analysis of the BiPerAge trial. BMC Geriatr. 2026 Oct 19;26(1):1306. doi: 10.1186/s12877-026-08491-7.
- Individual participant dataSharing planned: Yes. Data relative to this work will be available upon reasonable request to the principal investigators.
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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.
Robert Kob, PhD principal investigator
Institute for Biomedicine of Aging, Friederich-Alexander-Universität Erlangen-Nürnberg
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TSBR and PerTSBR in people with Older Adults and Exercise Training, run by University of Erlangen-Nürnberg Medical School at 2 sites in 2 countries.
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 8 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Israel. 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 Robert Kob, PhD (+49 911 530296624, robert.kob@fau.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of faults in the cycling course (time frame: changes over a period of 3 months and after a follow-up period of 6-9 months). 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 NCT06453473, 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 16 Sep 2025.