Safer Cycling In Older Age

Older Adults Clinical Trial

— SiFAr  

Official title:

"Safer Cycling In Older Age" - a Multi-component Exercise Intervention in Community-dwelling, Older Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04362514
• Other study ID #: IBA-2020-SiFAr
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 5, 2022

Study information

• Verified date: December 2022
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: December 5, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Community-dwelling
• Cycling Competence
• Older Adults

Intervention

Behavioral:
• MEPC - Multi-component exercise program related to cycling
Structured and progressive multicomponent exercise program with and without bikes. Training period will last over 3 months with 8 sessions à 60 minutes. Training sessions will address motor competence (balance, strength, cycling skills and techniques) and cognitive skills required during cycling. Furthermore, fall-related psychological concerns will be addressed.

Other:
• HRP - health-related presentations
HRP include 3 presentations on healthy aging (one per month) with a duration of 60 minutes

Locations

Country	Name	City	State
Germany	Institute for Biomedicine of Aging	Nürnberg	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	ADAC (The General German Automobile Club) foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Short Physical Performance Battery (SPPB)	mean change in sumscore (0-12 points)	changes over a period of 3 months and after a follow-up period of 6-9 and in some cases 18-21 months
Other	Fear of Falling (Short FES-I)	mean change in sumscore (7-28 points)	changes over a period of 3 months and after a follow-up period of 6-9 and in some cases 18-21 months
Other	Cortisol	change in concentration in nmol/L by high-sensitive Enzyme-linked Immunosorbent Assay (ELISA)	changes over a period of 3 months and after a follow-up period of 6-9 and in some cases 18-21 months
Other	Alpha-amylase	change in concentration in enzyme units U/mL by Enzyme kinetic Assay	changes over a period of 3 months and after a follow-up period of 6-9 and in some cases 18-21 months
Other	C-reactive protein (CRP)	change in concentration in mg/L by high-sensitive Enzyme-linked Immunosorbent Assay (ELISA)	changes over a period of 3 months and after a follow-up period of 6-9 and in some cases 18-21 months
Other	EuroQol (EQ-5D)	change in sumscore and change in mean value of Visual-Analogue-Scale (VAS, 0-100)	changes over a period of 3 months and after a follow-up period of 6-9 and in some cases 18-21 months
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 and in some cases 18-21 months