RecruitingNot ApplicableNCT06453473

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

The Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills and Behavior (BiPerAge): a Single Blind Randomized Controlled Trial

Sponsor

University of Erlangen-Nürnberg Medical School

Enrollment

127 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

Exercise Training Older Adults Bicycling

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

Min Age: 65 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether training on a specialized robotic stationary bicycle that delivers unexpected balance disturbances (perturbations) can help older adults aged 65 and over ride bicycles more safely in real life, by improving their balance and cycling skills. Falls and cycling accidents are a major concern in older adults, and training balance responses in a controlled environment may transfer to real-world cycling ability. Community-dwelling adults aged 65 and older who make at least 3 errors on a standardized cycling course test and are willing to be randomized are eligible, while those with severe heart or lung disease, neurological conditions, recent joint replacement, severe visual or cognitive impairment, or recent participation in another trial are excluded. Participants will complete 20 training sessions of 20 minutes each on the robotic bicycle over 3 months, either with perturbations (intervention) or without (active control), with cycling performance assessed before and after the training period. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTSBR

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.

OTHERPerTSBR

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.

Locations(2)

Friedrich-Alexander-Universität Erlangen-Nürnberg, Institut für Biomedizin des Alterns

Nuremberg, Bavaria, Germany

Physical Therapy department, faculty of health sciences, Ben-Gurion University of the Negev

Beersheba, Israel

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NCT06453473

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