Disability PhysicalNCT05252286
Exercise Strategies for Bedside Cases During Hospitalization
A study testing video watching, paper group and oral education group in people with Disability Physical and Hospitalization, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Disability Physical, Hospitalization
- What is being tested?
- video watching, paper group and oral education group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Functional dependence evaluated by Barthel Index
- Patients needed to rehabilitation program referred by medical doctor during hospitalization
- Be able to follow command and assessment
Who cannot join
- Impaired cognition
- Psychological problem from medical diagnosis
- Having a potential cardiac risk or severe disease diagnosis from medical doctor
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tzu Chi Buddhist General Hospital
Hualien City, 970
Chen Jia ching, master, 886-3-8565301 ext. 2493, chenjiaching0608@gmail.com
Chen Jia ching, master
About this study
Official title: Comparison of Three Types of Bedside Exercise Programs on Physical Functions of Hospitalized Patients
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 .
- Conditions
- Disability Physical, Hospitalization
- Being tested
- video watching, paper group, oral education group
- Keywords
- Hospital-Associated Disability, self-exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video watchingOther
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 groupOther
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 groupOther
the patient only receives the oral exercise education about how to improve their physical performance during their hospital stay.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: oral education group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to four weeks
Secondary outcomes (4)
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.
Measured: four weeks
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.
Measured: Up to four weeks
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.
Measured: Up to four weeks
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.
Measured: Up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start15 Mar 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-Ching Chen, Tzu Chi University
- Investigators
- Jia-Ching Chen, Principal investigator, Department of physical therapy, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252286
- Sponsor's protocol ID
- IRB110-193-A
- Status last verified
- Mar 2022
- First submitted
- 22 Jan 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Types of Bedside Exercise Programs on Physical Functions of Hospitalized Patients
- ClinicalTrials.gov ID
- NCT05252286
- Acronym / sponsor ID
- IRB110-193-A
- Conditions
- Disability Physical, Hospitalization
- Keywords
- Hospital-Associated Disability, self-exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| video watching | Experimental | Other: video watchingIn 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. |
| paper sheet | Active comparator | Other: paper groupFor 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. |
| oral health education group | Placebo comparator | Other: oral education groupIn 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. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Functional dependence evaluated by Barthel Index
- Patients needed to rehabilitation program referred by medical doctor during hospitalization
- Be able to follow command and assessment
Key exclusion criteria (3 listed)
- Impaired cognition
- Psychological problem from medical diagnosis
- Having a potential cardiac risk or severe disease diagnosis from medical doctor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video watchingWatching 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. | Other | video watching |
| paper groupIn 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. | Other | paper sheet |
| oral education groupthe patient only receives the oral exercise education about how to improve their physical performance during their hospital stay. | Other | oral health education group |
Primary outcome
Barthel Index (BI)
Time frame: Up to four weeks
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.
4 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: four weeks
Time Up and Go (TUG)
Time frame: Up to four weeks
de Morton Mobility Index (DEMMI)
Time frame: Up to four weeks
Hand-held dynamometer
Time frame: Up to four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia-Ching Chen principal investigator
Department of physical therapy, Tzu Chi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video watching, paper group and oral education group in people with Disability Physical and Hospitalization, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia-Ching Chen (886-3-8565301 ext. 2493, chenjiaching0608@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel Index (BI) (time frame: Up to four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.