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Clinical Trials in Germany / NCT06453473
Recruiting Not applicable

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

NCT06453473 · tracked via the Priya Life Science Germany tracker
Sponsor
University of Erlangen-Nürnberg Medical School
Phase
Not applicable
Started
2025-03-12
Last updated
2025-09-16

Condition(s) studied

Older AdultsExercise TrainingBicycling

Investigational drug(s) / intervention(s)

TSBRPerTSBR

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.

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.

Study 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. 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
100 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Number of faults in the cycling course — 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.

Trial sites (2)

FacilityCityRegionStatus
Friedrich-Alexander-Universität Erlangen-Nürnberg, Institut für Biomedizin des Alterns Nuremberg Bavaria Recruiting
Physical Therapy department, faculty of health sciences, Ben-Gurion University of the Negev Beersheba Israel Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06453473 on ClinicalTrials.gov ↗ ← All trials in Germany