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

NCT06453473 | Recruiting

• 1 other identifier: BGU-IBA-2024-BiPerAge
• Study Type: interventional
• Target: 127
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Older Adults; Exercise Training; Bicycling

Keywords

Bicycling; Perturbation; Balance control; Falls

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Balance Error Scoring System (BESS)

  changes over a period of 3 months and after a follow-up period of 6-9 months

• 5 Chair Stand Test

  changes over a period of 3 months and after a follow-up period of 6-9 months

• Four Square Step Test

  changes over a period of 3 months and after a follow-up period of 6-9 months

Other Outcomes (5)

• Bicycle falls efficacy scale

  changes over a period of 3 months and after a follow-up period of 6-9 months

• Short Physical Performance Battery (SPPB)

  changes over a period of 3 months and after a follow-up period of 6-9 months

• Heart rate variability (HRV)

  changes over a period of 3 months and after a follow-up period of 6-9 months

Study Arms (2)

training on the PerStBiRo with pertubation (PerTSBR)

EXPERIMENTAL

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

unperturbed training on the PerStBiRo (TSBR)

ACTIVE COMPARATOR

The active comparator group will pedall on the PerStBiRo system without perturbations.

Other: TSBR

Interventions

TSBR OTHER

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.

training on the PerStBiRo with pertubation (PerTSBR); unperturbed training on the PerStBiRo (TSBR)

PerTSBR OTHER

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.

training on the PerStBiRo with pertubation (PerTSBR)

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Ben-Gurion University of the Negev: collaborator

Study Sites (2)

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

Nuremberg, Bavaria, 90408, Germany

RECRUITING

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

Beersheba, 8410501, Israel

RECRUITING

Study Officials

• Robert Kob, PhD

  Institute for Biomedicine of Aging, Friederich-Alexander-Universität Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Kob, PhD

CONTACT

+49 911 530296624; robert.kob@fau.de

Itshak Melzer, PhD, P.T.

CONTACT

+972 8 6479521; itzikm@bgu.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures will be obtained by two research assistants in each country who are blinded to group allocation. Participants will not fully be blinded to group allocation since they notice whether perturbation occur during training. However, both groups will be told that the primary aim of the study is to improve cycling skills by training on an indoor, stationary bicycle.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: BiPerAge is a parallel group (1:1), randomized controlled trial with a duration of 3 years and a recruitment period between September 2024 and December 2025. Baseline data collection (T0) takes place in-person in the study center and in the cycle course on two different days within approximately 14 days. Except for cognitive function, same data are collected of all participants after the 3 months intervention period (T1), regardless of their compliance. In addition, participants will be followed up 6-9 months after T1 (T2) related to seasonal time frames (after winter season).

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: March 12, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• Access Criteria: Data relative to this work will be available upon reasonable request to the principal investigators.

Locations

DE (1); IL (1)