Bicycle Simulator Training in Older Adults: A Randomized Controlled Trial

NCT03636672 | Completed DMC

• 1 other identifier: BARZI0104
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized Control Trial will be conducted with Independent old adults (age 70 years old and older) who willing to participate in the study. They will be randomly allocated to two groups: 1) Stationary bicycle riding that includes perturbation balance training during riding; 2) Stationary bicycle riding that does not includes perturbation balance training during riding. Balance and Gait assessments will be tested before and after 3 months of training (2-3 times a week).

Conditions

Accidental Falls

Keywords

falls; Balance control; Aging; Balance reactions; Perturbation

Outcome Measures

Primary Outcomes (1)

• Compensatory Step Execution tests during Standing and Walking

  the time from perturbation to foot contact the floor completing the recovery stepping will be measured in milliseconds

  change from baseline to 3 months later

Secondary Outcomes (6)

• Postural Sway measure using force plate

  change from baseline to 3 months later

• Berg Balance Scale

  change from baseline to 3 months later

• 6-minute walk test (6MWT);

  change from baseline to 3 months later

• Late Life Function and Disability Instrument (LLFDI);

  change from baseline to 3 months later

• Falls Efficacy Scale-International

  change from baseline to 3 months later

Study Arms (2)

experimental

EXPERIMENTAL

Perturbation training during stationary bicycle riding

Procedure: perturbation training

control

ACTIVE COMPARATOR

stationary bicycle riding training

Procedure: perturbation training

Interventions

perturbation training PROCEDURE

perturbation training during stationary bicycle riding

control; experimental

Eligibility Criteria

• Age: 70 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• age 70 and over
• able to walk independently
• The provision of a medical certificate from the family physician allowing participation in physical training that requires walking two or three times a week.

You may not qualify if:

• suffers from ischemic heart disease which will restrict exercise and chronic obstructive pulmonary disease and uncontrolled blood pressure;
• severe vision problems (blindness);
• mini-mental score of 24 or more;
• At least one year after hip or knee replacement surgery or after fractures of the lower extremities;
• Amputation on the lower limb.
• neurological diseases or after a stroke

Sponsors & Collaborators

• Barzilai Medical Center: lead

Study Sites (1)

Ben-Gurion University of the Negev

Beersheba, 84105, Israel

Location

Related Publications (2)

• Batcir S, Livne K, Lehman RL, Berdichevsky Y, Maoz S, Shkedy LW, Adar R, Rabaev E, Bachner YG, Shani G, Lubovsky O, Shapiro A, Alexander NB, Melzer I. Feedback-based perturbation balance training during stationary cycling improves reactive and proactive balance among older adults: a single-blinded randomised controlled trial. Age Ageing. 2025 Aug 1;54(8):afaf215. doi: 10.1093/ageing/afaf215.

  PMID: 40794910 DERIVED

• Batcir S, Lubovsky O, Bachner YG, Melzer I. The Effects of Bicycle Simulator Training on Anticipatory and Compensatory Postural Control in Older Adults: Study Protocol for a Single-Blind Randomized Controlled Trial. Front Neurol. 2021 Jan 18;11:614664. doi: 10.3389/fneur.2020.614664. eCollection 2020.

  PMID: 33536998 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2018
• First Posted: August 17, 2018
• Study Start: March 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-07

Locations

IL (1)