Safer Cycling in Older Age

NCT04362514 | Completed DMC

• 1 other identifier: IBA-2020-SiFAr
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Older Adults; Community-dwelling; Cycling Competence

Keywords

Older cyclists; Bicycling; Multi-component exercise; Motor competence; Stress; Psychological concerns

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Short Physical Performance Battery (SPPB)

  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)

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

• Cortisol

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

Study Arms (2)

IG

EXPERIMENTAL

Intervention Group

Behavioral: MEPC - Multi-component exercise program related to cycling

aCG

ACTIVE COMPARATOR

Control Group

Other: HRP - health-related presentations

Interventions

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.

IG

HRP - health-related presentations OTHER

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

aCG

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• ADAC (The General German Automobile Club) foundation: collaborator

Study Sites (1)

Institute for Biomedicine of Aging

Nuremberg, Bavaria, 90408, Germany

Location

Related Publications (4)

• 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.

  PMID: 34641821 BACKGROUND

• Keppner V, Krumpoch S, Kob R, Rappl A, Sieber CC, Freiberger E, Siebentritt HM. Safer cycling in older age (SiFAr): effects of a multi-component cycle training. a randomized controlled trial. BMC Geriatr. 2023 Mar 7;23(1):131. doi: 10.1186/s12877-023-03816-2.

  PMID: 36882759 BACKGROUND

• Keppner V, Sieber CC, Freiberger E, Kob R, Krumpoch S, Siebentritt HM. Characteristics of older cyclists with self-perceived needs for improvement in cycling competence: SiFAr trial. Eur Geriatr Med. 2023 Jun;14(3):595-602. doi: 10.1007/s41999-023-00765-2. Epub 2023 Mar 28.

  PMID: 36973532 BACKGROUND

• 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.

  PMID: 34419134 DERIVED

Study Officials

• Robert Kob, PhD

  Institute for Biomedicine of Aging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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).

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 27, 2020
• Study Start: June 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: December 5, 2022
• Last Updated: December 6, 2024

Record last verified: 2022-12

Locations

DE (1)