Clinical trial NCT06453473: Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills
Official title: The Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills and Behavior (BiPerAge): a Single Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Older Adults
Exercise Training
Bicycling
Keywords: Bicycling
Perturbation
Balance control
Falls
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
First posted: 2024-06-11
Enrollment: 127
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of faults in the cycling course
timeFrame: changes over a period of 3 months and after a follow-up period of 6-9
Secondary outcomes:
measure: Balance Error Scoring System (BESS)
timeFrame: changes over a period of 3 months and after a follow-up period of 6-9
measure: 5 Chair Stand Test
timeFrame: changes over a period of 3 months and after a follow-up period of 6-9
measure: Four Square Step Test
timeFrame: changes over a period of 3 months and after a follow-up period of 6-9
Other outcomes:
measure: Bicycle falls efficacy scale
timeFrame: changes over a period of 3 months and after a follow-up period of 6-9
Locations:
city: Nuremberg
country: Germany
facility: Friedrich-Alexander-Universität Erlangen-Nürnberg, Institut für Biomedizin des Alterns
state: Bavaria
city: Be'er Sheva
country: Israel
facility: Physical Therapy department, faculty of health sciences, Ben-Gurion University of the Negev
Study officials:
affiliation: Institute for Biomedicine of Aging, Friederich-Alexander-Universität Erlangen-Nürnberg
name: Robert Kob, PhD
role: PRINCIPAL_INVESTIGATOR
References: