Safer Cycling in Older Age

Not Applicable

Completed

• Conditions: Cycling Competence; Community-dwelling; Older Adults
• Interventions: Behavioral: MEPC - Multi-component exercise program related to cycling; Other: HRP - health-related presentations

• Registration Number: NCT04362514
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

The aim of the SiFAr-project is to increase safe cycling in community-dwelling older adults (age 65 years and older) with a structured, multi-component exercise cycling training. The progressive exercise program encompasses training of motor competence and cognitive functions. 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. In Germany, the use of bicycles, especially of those with motorized assistance (e-bikes), is steadily increasing among older adults. Despite the benefits mentioned, cycling also poses potential health risks. For instance, there is a significant association between increased bicycle use and bicycle crashes. This relationship is particularly evident in older adults with a higher prevalence of bicycle crashes leading to minor and serious injuries. This might be explained by the age-related decline of physical and cognitive function, which may essentially affect (reduce) the ability to cycle safely. In order to prevent crashes and falls from bicycles, targeted training of the required skills for safe cycling could be effective. However, there is a lack of scientifically evaluated bicycle-training concepts that have been developed specifically for older adults.

By developing and providing a structured and progressive multi-component exercise program related to cycling for older adults, the SiFAr-project will address the improvement of bicycle-related basic motor competence (e.g. balance, strength, ability to react, cycling skills and techniques) and the reduction of stress and fall-related psychological concerns.

The ability to ride a bike safely will be measured in both arms before and after the training period by completing various tasks in a cycling course.

The aim of the program is that the participation in the three-month exercise intervention program will lead to a reduction of failures in the bicycle course. As comparative values, the number of faults in the bicycle course before the training period and the number of faults in the control group will be used. Furthermore, a substudy aim to investigate stress biomarkers targeting inflammatory and stress associated physiological parameters during cycling. The activity of stress systems will be determined by measuring stress hormones like cortisol and inflammatory responses in the body by measuring C-reactive protein. To analyse biomarkers, saliva, hair and blood specimen will be collected.

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-27
• Study Start: 2020-06-01
• Primary Completion: 2022-11-01
• Status Verified: 2022-12
• Study Completion: 2022-12-05
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

• living in the area Nürnberg-Fürth-Erlangen, Bavaria, Germany
• Ability to come to training locations on their own bicycle, having a suitable helmet
• participant is either 1) a beginner with the e-bike or has 2) self-reported insecurity or is 3) a re-entrant in cycling

Exclusion Criteria

• long-term, experienced cyclists without subjectively reported limitations or worries when cycling.
• diseases that contradict safe participation in the intervention (e.g. myocardial infarction within the last 6 months, unstable angina pectoris, cerebrovascular event, serious cancer diagnosis, serious neurological diseases like Parkinson, dementia; and other serious new diagnosis)
• other factor that prevent regular and safe participation in the intervention (e.g. prolonged holidays during the training period, alcoholism)
• severe visual impairments that cannot be sufficiently compensated by a visual aid

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IG	MEPC - Multi-component exercise program related to cycling	Intervention Group
aCG	HRP - health-related presentations	Control Group

Primary Outcome Measures

Name	Time	Method
Number of faults in the cycling course	changes over a period of 3 months and after a follow-up period of 6-9 and in some cases 18-21 months	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.

Trial Locations

Locations (1)

Institute for Biomedicine of Aging; 🇩🇪 Nürnberg, Bavaria, Germany