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Completed

NCT Number: NCT04362514

Safer Cycling In Older Age

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.

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Key information

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Biomedicine of Aging

Nuremberg, Bavaria, 90408, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEPC - Multi-component exercise program related to cycling

Behavioral

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.

HRP - health-related presentations

Other

HRP include 3 presentations on healthy aging (one per month) with a duration of 60 minutes

Primary outcomes

  1. 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 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.

Other outcomes

  1. Short Physical Performance Battery (SPPB)

    Time frame: changes over a period of 3 months and after a follow-up period of 6-9 and in some cases 18-21 months

    mean change in sumscore (0-12 points)

  2. Fear of Falling (Short FES-I)

    Time frame: changes over a period of 3 months and after a follow-up period of 6-9 and in some cases 18-21 months

    mean change in sumscore (7-28 points)

  3. Cortisol

    Time frame: changes over a period of 3 months and after a follow-up period of 6-9 and in some cases 18-21 months

    change in concentration in nmol/L by high-sensitive Enzyme-linked Immunosorbent Assay (ELISA)

  4. Alpha-amylase

    Time frame: changes over a period of 3 months and after a follow-up period of 6-9 and in some cases 18-21 months

    change in concentration in enzyme units U/mL by Enzyme kinetic Assay

  5. C-reactive protein (CRP)

    Time frame: changes over a period of 3 months and after a follow-up period of 6-9 and in some cases 18-21 months

    change in concentration in mg/L by high-sensitive Enzyme-linked Immunosorbent Assay (ELISA)

  6. EuroQol (EQ-5D)

    Time frame: changes over a period of 3 months and after a follow-up period of 6-9 and in some cases 18-21 months

    change in sumscore and change in mean value of Visual-Analogue-Scale (VAS, 0-100)

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • ADAC (The General German Automobile Club) foundation

Registry information

Official study title

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

Acronym: SiFAr

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2020
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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