Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills
- Conditions
- Older AdultsExercise TrainingBicycling
- Interventions
- Other: TSBROther: PerTSBR
- Registration Number
- NCT06453473
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 127
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description training on the PerStBiRo with pertubation (PerTSBR) PerTSBR The experimental group will pedall on the PerStBiRo system like the active comparator group but will receive additional roll- and pitch-angles balance perturbations. training on the PerStBiRo with pertubation (PerTSBR) TSBR The experimental group will pedall on the PerStBiRo system like the active comparator group but will receive additional roll- and pitch-angles balance perturbations. unperturbed training on the PerStBiRo (TSBR) TSBR The active comparator group will pedall on the PerStBiRo system without perturbations.
- Primary Outcome Measures
Name Time Method Number of faults in the cycling course changes over a period of 3 months and after a follow-up period of 6-9 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 Outcome Measures
Name Time Method Four Square Step Test changes over a period of 3 months and after a follow-up period of 6-9 mean change of time in seconds for measurement of dynamic balance
Balance Error Scoring System (BESS) changes over a period of 3 months and after a follow-up period of 6-9 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
5 Chair Stand Test changes over a period of 3 months and after a follow-up period of 6-9 mean change of time in seconds for measurement of muscle power of the legs
Trial Locations
- 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
🇮🇱Be'er Sheva, Israel