NCT07195526

Brief Summary

This study investigates the effectiveness of an intervention that aims at restoring bicycle balance control skills in seniors that have quit cycling. The intervention will last 11 weeks and involves three components: (1) training on an exercise bicycle, (2) a balance control training on a bicycle simulator, and (3) cycling on the public roads with a safe start-and-stop technique that was practiced on the bicycle simulator. In the bicycle simulator training, the difficulty of the balance control will be increased gradually, slowly approaching the difficulty of bicycle balance control on the public roads.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

September 19, 2025

Last Update Submit

September 19, 2025

Conditions

Keywords

Balance controlbicycle balancemotor skill trainingmobility

Outcome Measures

Primary Outcomes (1)

  • Bicycle balance control skill and confidence

    This outcome variable will be obtained from a questionnaire that evaluates participants' bicycle BC skills and confidence while riding on the public roads. For each of three environments (without traffic, little traffic, busy traffic), participants must indicate what applies to them: (1) "I did not ride my bicycle here", (2) "I rode my bicycle here, but I try to avoid it", and (3) "I rode my bicycle here without problems". The answers to every question/environment were converted into a score by assigning 0, 1, and 2 points to the respective options. Summing these scores over the three questions/environments results in a number between 0 and 6, which is the outcome variable.

    Pretest: Between the second and the third week of June 2023 Posttest: First week of October 2023

Secondary Outcomes (1)

  • One-minute functional threshold power (1minFTP)

    From the third week of June 2023 until the second week of August 2023

Study Arms (2)

Bicycle balance control training

EXPERIMENTAL

The intervention involveds three components: (1) training on an exercise bicycle, (2) a balance control training on a bicycle simulator, and (3) cycling on the public roads with a safe start-and-stop technique that will be practiced on the bicycle simulator. In the bicycle simulator training, the difficulty of the balance control was increased gradually, slowly approaching the difficulty of bicycle balance control on the public roads.

Behavioral: Bicycle balance control training

Control group

NO INTERVENTION

The participants in the experimental group are matched to the participants in the control group. The control group participants are selected based on their distance from the location of the intervention; control group participants live farther away from the location of the intervention as compared to the experimental group.

Interventions

The intervention involves three components: (1) training on an exercise bicycle, (2) a balance control training on a bicycle simulator, and (3) cycling on the public roads with a safe start-and-stop technique that was practiced on the bicycle simulator. In the bicycle simulator training, the difficulty of the balance control will be increased gradually, slowly approaching the difficulty of bicycle balance control on the public roads.

Bicycle balance control training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Persons that stopped cycling at least six months ago and want to get back on their bicycle.

You may not qualify if:

  • Balance-relevant sensory disorders (peripheral neuropathy, labyrinthitis, vestibular neuritis, …)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Social Sciences Research labs and Radboud University Sports Center

Nijmegen, 6500 HE, Netherlands

Location

Study Officials

  • Eric Maris, PhD

    Donders Centre for Cognitive Neuroimaging

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2025

First Posted

September 26, 2025

Study Start

March 31, 2023

Primary Completion

October 6, 2023

Study Completion

October 6, 2023

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations