Safer Cycling In Older Age
Condition: Older Adults; Community-dwelling; Cycling Competence
Study type: Interventional

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.
    

Intervention name(s): MEPC - Multi-component exercise program related to cycling; HRP - health-related presentations
Intervention type(s): Behavioral; Other
Intervention description(s): 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 include 3 presentations on healthy aging (one per month) with a duration of 60 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SiFAr is a parallel group, randomized controlled trial with a duration of 3 years and a recruitment period between June 2020 and July 2022. The 1:1 randomization of participants to IG or aCG is stratified by gender and bicycle type (e-bikes/unmotorized bicycle).
Baseline data collection (T0) takes place in-person in the study center and in the cycle course on two different days within approximately 14 days. Except for cognitive function, same data are collected of all participants after the 3 months intervention period (T1), regardless of their compliance. In addition, participants will be followed up 6-9 months after T1 (T2) related to seasonal time frames (after winter season). Furthermore, participants of the IG 2020 will be measured for a long-term follow-up in the third year of the study (T3).
Masking: None (Open Label)
Primary purpose: Other
Keywords: Older cyclists; Bicycling; Multi-component exercise; Motor competence; Stress; Psychological concerns