Benefits of Cycling Wheelchair Training for Elderly With Physical Disability

To investigate the feasibility of cycling wheelchair training as an exercise for elderly disabled patients, and to determine its effects on cognition, quality of life, aerobic capacity and physiological markers. We measure SF-12. Other outcome measures included the Mini-Mental State Examination, Aero bike workload test, resting blood pressure (systolic and diastolic), and heart rate.

Study Overview

• Status: Completed
• Conditions: Aged; Disable; Exercise; Rehabilitation; Wheelchair
• Intervention / Treatment: Device: Cycling wheelchair

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age >65 years old
2. with a functional ambulation category scale (FAC) level 4 or below
3. muscle strength of both lower limbs was >3 as the , or the muscle strength of one lower limb was 4 or above, as rated by the Medical Research Council Scale (MRC).

Exclusion Criteria:

1. hospitalized for acute medical problems within the past 3 months
2. having cardiopulmonary disease that could cause exercise hazards
3. unable to perform repetitive pedaling exercise due to diseases of the lower limbs
4. with pressure ulcers around hip area
5. with impaired cognitive function that did not allow completion of our questionnaires.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cycyling wheelchair; Volunteers join the cycling wheelchair training	Device: Cycling wheelchair; Apply the mechanical principle of pedaling on a bicycle to a conventional wheelchair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-12	Quality of life	one month
MMSE questionnaire	Cognitive function	one month
Cycling ergometer	Aerobic capacity	one month

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2021
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: June 19, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (ACTUAL): August 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CE22294A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No discuss with volunteers about sharing data to third party

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No