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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05252286
Other study ID # IRB110-193-A
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 15, 2022
Est. completion date December 2023

Study information

Verified date March 2022
Source Buddhist Tzu Chi General Hospital
Contact Jia-Ching Chen
Phone 886-3-8565301
Email chenjiaching0608@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 90 Years
Eligibility Inclusion Criteria: 1. Functional dependence evaluated by Barthel Index 2. Patients needed to rehabilitation program referred by medical doctor during hospitalization 3. Be able to follow command and assessment Exclusion Criteria: 1. Impaired cognition 2. Psychological problem from medical diagnosis 3. Having a potential cardiac risk or severe disease diagnosis from medical doctor

Study Design


Related Conditions & MeSH terms


Intervention

Other:
video watching
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.
paper group
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.
oral education group
the patient only receives the oral exercise education about how to improve their physical performance during their hospital stay.

Locations

Country Name City State
Taiwan Tzu Chi Buddhist General Hospital Hualien City

Sponsors (1)

Lead Sponsor Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Short Physical Performance Battery (SPPB) The investigators will use the SPPB as the secondary outcome measure in this study to evaluate the lower extremity functioning and physical mobility at baseline before intervention, one week after intervention, and the time at discharge. SPPB is scored 0 to 12, the higher score and the better physical mobility. four weeks
Secondary Time Up and Go (TUG) The investigators will use the TUG as the secondary outcome measure in this study to evaluate the balance mobility at baseline before intervention, one week after intervention, and the time at discharge. TUG is recorded as the seconds, the shorter timing and the better balance function. Up to four weeks
Secondary de Morton Mobility Index (DEMMI) The investigators will use the DEMMI as the secondary outcome measure in this study to evaluate the physical mobility at baseline before intervention, one week after intervention, and the time at discharge. The DEMMI consists of 15 items with score 0-100, and the higher score, the better performane. Up to four weeks
Secondary Hand-held dynamometer The investigators will use the hand-held dynamometer as the secondary outcome measure in this study to evaluate the muscle strength at baseline before intervention, one week after intervention, and the time at discharge. Up to four weeks
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