Safer Cycling In Older Age (SiFAr)

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Nürnberg, Bavaria, Germany, 90408
      • Institute for Biomedicine of Aging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IG; Intervention Group	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.
Active Comparator: aCG; Control Group	Other: HRP - health-related presentations; HRP include 3 presentations on healthy aging (one per month) with a duration of 60 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: ADAC (The General German Automobile Club) foundation
• Investigators: Principal Investigator: Robert Kob, PhD, Institute for Biomedicine of Aging

Publications and helpful links

General Publications

• Siebentritt HM, Keppner V, Britting S, Kob R, Rappl A, Sieber CC, Freiberger E. Safer cycling in older age (SiFAr): a protocol of a randomized controlled trial. BMC Geriatr. 2021 Oct 12;21(1):546. doi: 10.1186/s12877-021-02502-5.
• Britting S, Kob R, Sieber CC, Rohleder N, Freiberger E, Becker L. Physiological stress in safer cycling in older age (SiFAr-stress): effect of a multicomponent exercise intervention-a study protocol for a randomized controlled trial. Trials. 2021 Aug 21;22(1):552. doi: 10.1186/s13063-021-05481-5.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): December 5, 2022

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Stress; Older cyclists; Bicycling; Multi-component exercise; Motor competence; Psychological concerns
• Other Study ID Numbers: IBA-2020-SiFAr

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No