NCT05252286

Brief Summary

Patients after hospital admission would experience the functional decline, so-called Hospital-Associated Disability. This condition could not only impact the patient health function but pose a burden on the family, even more consuming of medical resource in the country. Therefore, in addition to routine rehabilitation program, various bedside exercise programs are provided as an adjunct therapy to prevent functional declination and improve physical mobility for a patient after hospital admission. The aims of the study are conducted to compare the effect of three various bedside exercise programs (exercise based on watching video, oral education and paper sheet) on physical mobility among the hospitalized patients. This is single-blind randomized control study and patients recruited from Tzu-Chi medical center in eastern Taiwan are ranged from 30 to 90 years old. All participants are randomly assigned to three groups (watching video, oral education and paper sheet). Patients in watching video group are provided with theirs 3 to 5 poor physical performance video recorded on the tablet or mobile phone during the rehabilitation program. The other two groups are provided oral education and paper sheet exercise program, respectively. All three groups patients conduct their bedside exercise programs when they return their ward. Physical performance tests are evaluated before the intervention and one or two days before discharge by a physical therapist blinded the groups of patient .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

1.7 years

First QC Date

January 22, 2022

Last Update Submit

March 15, 2022

Conditions

Keywords

Hospital-Associated Disabilityself-exercise

Outcome Measures

Primary Outcomes (1)

  • Barthel Index (BI)

    The investigators will use the BI as the primary outcome measure in this study to evaluate activity of daily living at baseline before intervention, one week after intervention, and the time at discharge. BI is scored 0 to 100, the higher score and the better functional performance.

    Up to four weeks

Secondary Outcomes (4)

  • Short Physical Performance Battery (SPPB)

    four weeks

  • Time Up and Go (TUG)

    Up to four weeks

  • de Morton Mobility Index (DEMMI)

    Up to four weeks

  • Hand-held dynamometer

    Up to four weeks

Study Arms (3)

video watching

EXPERIMENTAL

In the video-watching group, a patient will follow the exercise instructions from watching the video. The exercise content in video are set during the patient conducting the rehabilitation program. Then, the therapist will select 3 to 5 groups of movements pattern needed to be enhanced catching from the video for the patient to practice when returning the bedside after the rehabilitation programs.

Other: video watching

paper sheet

ACTIVE COMPARATOR

For the paper sheet group, the therapist will prepare the exercise leaflet, suitable for the patients, in advance, and select three to five groups of movement exercises on the leaflet that his/her therapist deem the patients needed to be enhanced. When the patients ends his/her rehabilitation program, they can practice following the instructions on the leaflet for them-self in bedside.

Other: paper group

oral health education group

PLACEBO COMPARATOR

In the oral health education group, the program is similar to the paper sheet group without providing any exercise paper sheet the patient but oral education.

Other: oral education group

Interventions

Watching video In this group, when the patient conducts their rehabilitation exercise, the therapist would record the poor physical movement pattern from his/her performance by using the mobile phone or tablet. The patients will be provided with watching video exercise, containing 3-5 items of "their poor physical performance", selected by the therapist as a feedback to let the patient practice when they return their bedside ward after their rehabilitation time. The content of video-watching exercise program will be changed or modified once weekly as the patient improve the physical movement performance.

video watching

In the paper sheet group, the therapist will give three to five poor movement patterns, selected from the patient conducting their rehabilitation program, to practice when returning bedside ward.

paper sheet

the patient only receives the oral exercise education about how to improve their physical performance during their hospital stay.

oral health education group

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Functional dependence evaluated by Barthel Index
  • Patients needed to rehabilitation program referred by medical doctor during hospitalization
  • Be able to follow command and assessment

You may not qualify if:

  • Impaired cognition
  • Psychological problem from medical diagnosis
  • Having a potential cardiac risk or severe disease diagnosis from medical doctor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tzu Chi Buddhist General Hospital

Hualien City, 970, Taiwan

RECRUITING

Study Officials

  • Jia-Ching Chen

    Department of physical therapy, Tzu Chi University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Department of physical therapy

Study Record Dates

First Submitted

January 22, 2022

First Posted

February 23, 2022

Study Start

March 15, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations