Bicycling, Exercise Training, Older Adults
Conditions
Keywords
Bicycling, Perturbation, Balance control, Falls
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.
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.
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.
Sponsors
Ben-Gurion University of the Negev
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Four Square Step Test | changes over a period of 3 months and after a follow-up period of 6-9 months | mean change of time in seconds for measurement of dynamic balance |
| 5 Chair Stand Test | changes over a period of 3 months and after a follow-up period of 6-9 months | mean change of time in seconds for measurement of muscle power of the legs |
| Balance Error Scoring System (BESS) | changes over a period of 3 months and after a follow-up period of 6-9 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Balance recovery score | changes over a period of 3 months and after a follow-up period of 6-9 months | 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 |
| Predicted maximal oxygen consumption (VO₂max) | changes over a period of 3 months and after a follow-up period of 6-9 months | mean change of predicted maximal oxygen consumption estimated via the submaximal Ekblom-Bak cycle ergometer test, higher maximal oxygen consumption indicates better physical fitness |
| Bicycle falls efficacy scale | changes over a period of 3 months and after a follow-up period of 6-9 months | 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 |
| Short Physical Performance Battery (SPPB) | changes over a period of 3 months and after a follow-up period of 6-9 months | mean change in sumscore (0-12 points) for measurement of static balance, gait speed and chair stand test, more points indicate better physical functioning |
| Heart rate variability (HRV) | changes over a period of 3 months and after a follow-up period of 6-9 months | mean change of measured heart rate variability , higher scores indicate better cardiac autonomic nervous system function |
Countries
Germany, Israel
Contacts
Primary ContactRobert Kob, PhD
Backup ContactItshak Melzer, PhD, P.T.
Outcome results
None listed