An interventional study of TSBR and PerTSBR in Older Adults, Exercise Training and Bicycling, sponsored by University of Erlangen-Nürnberg Medical School. Recruiting at 2 sites in 2 countries. Open to participants aged 65 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Other
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.
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.
University of Erlangen-Nürnberg Medical School is the lead sponsor of 267 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
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: TSBR · Other: PerTSBR
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.
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.
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.
Time frame: changes over a period of 3 months and after a follow-up period of 6-9 months
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
Time frame: 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
Time frame: 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
Time frame: changes over a period of 3 months and after a follow-up period of 6-9 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: changes over a period of 3 months and after a follow-up period of 6-9 months
Plan to share: Yes — Data relative to this work will be available upon reasonable request to the principal investigators.
Supporting information: Study protocol, Icf
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University of Erlangen-Nürnberg Medical School