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

University of Erlangen-Nürnberg Medical School

Status: Enrolling

Conditions: Exercise Training; Bicycling; Older Adults

Treatments: Other: TSBR; Other: PerTSBR

Study type: Interventional

Funder types: Other

Identifiers

NCT06453473

BGU-IBA-2024-BiPerAge

Details and patient eligibility

About

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.

Full 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.

Enrollment: 127 estimated patients

Sex: All

Ages: 65 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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127 participants in 2 patient groups

training on the PerStBiRo with pertubation (PerTSBR)

Experimental group

Description:

The experimental group will pedall on the PerStBiRo system like the active comparator group but will receive additional roll- and pitch-angles balance perturbations.

Treatment:

Other: PerTSBR

Other: TSBR

unperturbed training on the PerStBiRo (TSBR)

Active Comparator group

Description:

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

Treatment:

Other: TSBR