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

Overview

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.

Interventions

• 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 maintain moderate-intensit
• Other 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.

Primary outcome measures

• Number of faults in the cycling course [Time frame: changes over a period of 3 months and after a follow-up period of 6-9 months]

Secondary outcome measures (3)

• Balance Error Scoring System (BESS) [Time frame: changes over a period of 3 months and after a follow-up period of 6-9 months]
• 5 Chair Stand Test [Time frame: changes over a period of 3 months and after a follow-up period of 6-9 months]
• Four Square Step Test [Time frame: changes over a period of 3 months and after a follow-up period of 6-9 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Germany · 1 center

• Friedrich-Alexander-Universität Erlangen-Nürnberg, Institut für Biomedizin des Alterns — Nuremberg

Israel · 1 center

• Physical Therapy department, faculty of health sciences, Ben-Gurion University of the Nege — Beersheba

Identifiers

NCT: NCT06453473 · BGU-IBA-2024-BiPerAge

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗