Benefits of Cycling Wheelchair Training for Elderly With... | NCT05487898

Studies
Benefits of Cycling Wheelchair Training for Elderly With Physical Disability

NCT05487898

Sponsor

Taichung Veterans General Hospital

Status

Completed

Last Update Posted

Aug 4, 2022Actual

Enrollment

41Actual

Phase

Not Applicable

Conditions

Aged; Disable; Exercise; Rehabilitation; Wheelchair

Interventions

Cycling wheelchair

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Jun 19, 2022

First Submission Date that Met QC Criteria

Aug 2, 2022

First Posted Date

Aug 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2022

Last Update Posted Date

Aug 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cycyling wheelchair	Experimental	Volunteers join the cycling wheelchair training	Device: Cycling wheelchair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cycling wheelchair	Device	Apply the mechanical principle of pedaling on a bicycle to a conventional wheelchair	Cycyling wheelchair

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >65 years old
with a functional ambulation category scale (FAC) level 4 or below
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:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

100 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taichung Veterans General Hospital		Taichung			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36554652	Derived	Fu JC, Fu PK, Cheng YY. Benefits of Cycling Wheelchair Training for Elderly with Physical Disability: A Prospective Cohort Study. Int J Environ Res Public Health. 2022 Dec 14;19(24):16773. doi: 10.3390/ijerph192416773.