Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills (BiPerAge)

September 9, 2025 updated by: University of Erlangen-Nürnberg Medical School

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
127

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Itshak Melzer, PhD, P.T.
  • Phone Number: +972 8 6479521
  • Email: itzikm@bgu.ac.il

Study Locations

  • Germany
    • Bavaria
      • Nuremberg, Bavaria, Germany, 90408
        • Recruiting
        • Friedrich-Alexander-Universität Erlangen-Nürnberg, Institut für Biomedizin des Alterns
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Susanne Muck
        • Sub-Investigator:
          • Jana Rogler
  • Israel
      • Beersheba, Israel, 8410501
        • Recruiting
        • Physical Therapy department, faculty of health sciences, Ben-Gurion University of the Negev
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: training on the PerStBiRo with pertubation (PerTSBR)
The experimental group will pedall on the PerStBiRo system like the active comparator group but will receive additional roll- and pitch-angles balance perturbations.
Other: PerTSBR
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.
Other: TSBR

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.
Active Comparator: unperturbed training on the PerStBiRo (TSBR)
The active comparator group will pedall on the PerStBiRo system without perturbations.
Other: TSBR

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
changes over a period of 3 months and after a follow-up period of 6-9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Balance Error Scoring System (BESS)
Time Frame: changes over a period of 3 months and after a follow-up period of 6-9 months
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
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
mean change of time in seconds for measurement of muscle power of the legs
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
mean change of time in seconds for measurement of dynamic balance
changes over a period of 3 months and after a follow-up period of 6-9 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bicycle falls efficacy scale
Time Frame: changes over a period of 3 months and after a follow-up period of 6-9 months
mean change of sumscore in an own developed questionnaire regarding concerns about falling from the bicycle (14-56 points), higher score indicates increased concerns about falling off the bicycle
changes over a period of 3 months and after a follow-up period of 6-9 months
Short Physical Performance Battery (SPPB)
Time Frame: changes over a period of 3 months and after a follow-up period of 6-9 months
mean change in sumscore (0-12 points) for measurement of static balance, gait speed and chair stand test, more points indicate better physical functioning
changes over a period of 3 months and after a follow-up period of 6-9 months
Heart rate variability (HRV)
Time Frame: changes over a period of 3 months and after a follow-up period of 6-9 months
mean change of measured heart rate variability , higher scores indicate better cardiac autonomic nervous system function
changes over a period of 3 months and after a follow-up period of 6-9 months
Balance recovery score
Time Frame: changes over a period of 3 months and after a follow-up period of 6-9 months
mean change of measured balance recovery score that is based on the time needed to counteract the perturbations on the stationary bike during a standardized perturbation intervention, higher scores indicate better balance reactions
changes over a period of 3 months and after a follow-up period of 6-9 months
Predicted maximal oxygen consumption (VO₂max)
Time Frame: changes over a period of 3 months and after a follow-up period of 6-9 months
mean change of predicted maximal oxygen consumption estimated via the submaximal Ekblom-Bak cycle ergometer test, higher maximal oxygen consumption indicates better physical fitness
changes over a period of 3 months and after a follow-up period of 6-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Erlangen-Nürnberg Medical School

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ben-Gurion University of the Negev

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Kob, PhD, Institute for Biomedicine of Aging, Friederich-Alexander-Universität Erlangen-Nürnberg

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BGU-IBA-2024-BiPerAge

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data relative to this work will be available upon reasonable request to the principal investigators.

IPD Sharing Time Frame

The data could be requested after the publication of the primary study results and will be kept available for at least 10 years after completion of the study.

IPD Sharing Access Criteria

Data relative to this work will be available upon reasonable request to the principal investigators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

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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