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

Older Adults Clinical Trial

— BiPerAge  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06453473
• Other study ID #: BGU-IBA-2024-BiPerAge
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: March 2027

Study information

• Verified date: May 2024
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Robert Kob, PhD
• Phone: +49 911 530296624
• Email: robert.kob[@]fau.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 127
• Est. completion date: March 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise Training
• Older Adults

Intervention

Other:
• TSBR
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 reach a training at 60%-80% of maximal pulse, 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
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

Country	Name	City	State
Germany	Friedrich-Alexander-Universität Erlangen-Nürnberg, Institut für Biomedizin des Alterns	Nuremberg	Bavaria
Israel	Physical Therapy department, faculty of health sciences, Ben-Gurion University of the Negev	Be'er Sheva

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Ben-Gurion University of the Negev

Countries where clinical trial is conducted

Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	changes over a period of 3 months and after a follow-up period of 6-9
Primary	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
Secondary	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	changes over a period of 3 months and after a follow-up period of 6-9
Secondary	5 Chair Stand Test	mean change of time in seconds for measurement of muscle power of the legs	changes over a period of 3 months and after a follow-up period of 6-9
Secondary	Four Square Step Test	mean change of time in seconds for measurement of dynamic balance	changes over a period of 3 months and after a follow-up period of 6-9