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

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: Recruiting
• Conditions: Exercise Training; Older Adults; Bicycling
• Intervention / Treatment: Other: PerTSBR; Other: TSBR

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: Interventional
• Enrollment (Estimated): 127
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Kob, PhD; Phone Number: +49 911 530296624; Email: robert.kob@fau.de
• 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: Robert Kob, PhD; Phone Number: +49 911 5302 96624; Email: robert.kob@fau.de
      • Contact: Sebastian Krumpoch, PhD; Phone Number: +49 911 5302 96176; Email: sebastian.krumpoch@fau.de
      • 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: Itshak Melzer, PhD, P.T.; Phone Number: +972 8 6479521; Email: itzikm@bgu.ac.il

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	changes over a period of 3 months and after a follow-up period of 6-9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	changes over a period of 3 months and after a follow-up period of 6-9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bicycle falls efficacy scale	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)	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)	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	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)	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

• Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: Ben-Gurion University of the Negev
• Investigators: Principal Investigator: Robert Kob, PhD, Institute for Biomedicine of Aging, Friederich-Alexander-Universität Erlangen-Nürnberg

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Balance control; Falls; Bicycling; Perturbation
• Other Study ID 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