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Safer Cycling in Older Age

NCT ID: NCT04362514

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-12-05

Brief Summary

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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

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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.

Conditions

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Older Adults Community-dwelling Cycling Competence

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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IG

Intervention Group

Group Type EXPERIMENTAL

MEPC - Multi-component exercise program related to cycling

Intervention Type 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.

aCG

Control Group

Group Type ACTIVE_COMPARATOR

HRP - health-related presentations

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

HRP - health-related presentations

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ADAC (The General German Automobile Club) foundation

UNKNOWN

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Robert Kob

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Kob, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Biomedicine of Aging

Locations

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Institute for Biomedicine of Aging

Nuremberg, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 34641821 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36882759 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36973532 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34419134 (View on PubMed)

Other Identifiers

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IBA-2020-SiFAr

Identifier Type: -

Identifier Source: org_study_id