Older AdultsSiFArNCT04362514
Safer Cycling In Older Age
A study testing MEPC - Multi-component exercise program related to cycling and HRP - health-related presentations in people with Older Adults and Community-dwelling, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Older Adults, Community-dwelling, Cycling Competence
- What is being tested?
- MEPC - Multi-component exercise program related to cycling and HRP - health-related presentations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2020to 5 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
Read the 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.
- Conditions
- Older Adults, Community-dwelling, Cycling Competence
- Being tested
- MEPC - Multi-component exercise program related to cycling, HRP - health-related presentations
- Keywords
- Older cyclists, Bicycling, Multi-component exercise, Motor competence, Stress, Psychological concerns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEPC - Multi-component exercise program related to cyclingBehavioural
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 presentationsOther
HRP include 3 presentations on healthy aging (one per month) with a duration of 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| IG | Experimental | Intervention Group Receives: Behavioral: MEPC - Multi-component exercise program related to cycling |
| aCG | Active comparator | Control Group Receives: Other: HRP - health-related presentations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: changes over a period of 3 months and after a follow-up period of 6-9 and in some cases 18-21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start1 Jun 2020
- Primary completion1 Nov 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- ADAC (The General German Automobile Club) foundation
- Responsible party
- Principal investigator, Robert Kob, Friedrich-Alexander-Universität Erlangen-Nürnberg
- Investigators
- Robert Kob, PhD, Principal investigator, Institute for Biomedicine of Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362514
- Sponsor's protocol ID
- IBA-2020-SiFAr
- Acronym
- SiFAr
- Status last verified
- Dec 2022
- First submitted
- 14 Apr 2020
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34641821Keppner 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.
PubMed 36882759Keppner 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.
PubMed 36973532Britting 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.
PubMed 34419134
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Safer Cycling In Older Age" - a Multi-component Exercise Intervention in Community-dwelling, Older Adults.
- ClinicalTrials.gov ID
- NCT04362514
- Acronym / sponsor ID
- SiFAr / IBA-2020-SiFAr
- Conditions
- Older Adults, Community-dwelling, Cycling Competence
- Keywords
- Older cyclists, Bicycling, Multi-component exercise, Motor competence, Stress, Psychological concerns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- ADAC (The General German Automobile Club) foundation
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| IG | Experimental | Behavioral: MEPC - Multi-component exercise program related to cyclingIntervention Group |
| aCG | Active comparator | Other: HRP - health-related presentationsControl Group |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEPC - Multi-component exercise program related to cyclingStructured 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. | Behavioural | IG |
| HRP - health-related presentationsHRP include 3 presentations on healthy aging (one per month) with a duration of 60 minutes | Other | aCG |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Results publication: PubMed 34641821Siebentritt 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.
- Results publication: PubMed 36882759Keppner 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.
- Results publication: PubMed 36973532Keppner 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.
- Derived from this study: PubMed 34419134Britting 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Kob, PhD principal investigator
Institute for Biomedicine of Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEPC - Multi-component exercise program related to cycling and HRP - health-related presentations in people with Older Adults and Community-dwelling, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04362514, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.