Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorUniversity of Erlangen-Nürnberg Medical School
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
TSBR
Other interventionThe 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
Other interventionParticipants 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.
Treatment groups
127 Participants
are divided into 2 treatment groupsGroup A: training on the PerStBiRo with pertubation (PerTSBR)Experimental treatment 2 interventions
Group B: unperturbed training on the PerStBiRo (TSBR)Active comparator 1 intervention
Trial outcomes
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.
Time frame
changes over a period of 3 months and after a follow-up period of 6-9 monthsSecondary outcomes
1
Balance Error Scoring System (BESS)
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
Time frame
changes over a period of 3 months and after a follow-up period of 6-9 months2
5 Chair Stand Test
mean change of time in seconds for measurement of muscle power of the legs
Time frame
changes over a period of 3 months and after a follow-up period of 6-9 months3
Four Square Step Test
mean change of time in seconds for measurement of dynamic balance
Time frame
changes over a period of 3 months and after a follow-up period of 6-9 monthsOther outcomes
1
Bicycle falls efficacy scale
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
Time frame
changes over a period of 3 months and after a follow-up period of 6-9 months2
Short Physical Performance Battery (SPPB)
mean change in sumscore (0-12 points) for measurement of static balance, gait speed and chair stand test, more points indicate better physical functioning
Time frame
changes over a period of 3 months and after a follow-up period of 6-9 months3
Heart rate variability (HRV)
mean change of measured heart rate variability , higher scores indicate better cardiac autonomic nervous system function
Time frame
changes over a period of 3 months and after a follow-up period of 6-9 months4
Balance recovery score
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
Time frame
changes over a period of 3 months and after a follow-up period of 6-9 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Erlangen-Nürnberg Medical School
Lead sponsor
Ben-Gurion University of the Negev
Collaborator
Source ClinicalTrials.gov