SarcopeniaHRSNCT05687630
Effect of Technology-assisted Physical Therapy for Patient With High Risk of Sarcopenia
A study testing elastic band resisted exercise in people with Sarcopenia, run by National Taiwan University Hospital.
Trial summary
This research aims to identify whether the effects of video-assisted physical therapy, including home resistance training, is superior to traditional physical therapy, education leaflet for example. This is an interventional research, single-blind, randomized control trail. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- elastic band resisted exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 30 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age above 65 years old
- MMSE > 24 points
- walking more than 6 meters independently
Who cannot join
- people who cannot participate for 3 -day exercise for each week
Trial locations and contacts
No sites are listed yet.
About this study
This research aims to identify whether the effects of video-assisted physical therapy, including home resistance training, is superior to traditional physical therapy, education leaflet for example.
This is an interventional research, single-blind, randomized control trail. We recruit high risk of sarcopenia people (low muscle strength and low physical performance) Two groups of participants are divided into traditional group and video-assisted group, both group are taught the same resisted exercise by physical therapist.
Read the detailed description
Both group will record his/her baseline activity level with a given pedometer. After one week recording, we started initial evaluation (history taking, physical examination) and intervention.
Participants are taught thera-band resisted exercise, including large musculature of upper and lower extremities, each exercise are conducted 10-15 times for 3 sets.
Traditional group will receive an education leaflet and a notebook to record his/ her daily activity and frequency of exercise to record the compliance.
Video-assisted group will receive a QR code, which contain a website of exercise video on the cloud.
After 3 months intervention, participant will come back to our center for final examination.
- Conditions
- Sarcopenia
- Being tested
- elastic band resisted exercise
- Keywords
- sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elastic band resisted exerciseOther
Also called resisted exercise
muscle strengthening exercise, 10-15 times of each set, for 3 sets
| Study group | Role | What they receive |
|---|---|---|
| Video-assisted group | Experimental | Not described Receives: Other: elastic band resisted exercise |
| Traditional group | Active comparator | Not described Receives: Other: elastic band resisted exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
use hand dynamometer to test maximal strength
Measured: three months after initial evaluation
walking speed
walk for 4 meters to test the time that participant used
Measured: three months after initial evaluation
Timed up-and-go test
Measured: three months after initial evaluation
Secondary outcomes (1)
Short Physical Performance Battery (SPPB)
Measured: three months after initial evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Yu Kuo, Bachelor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687630
- Sponsor's protocol ID
- 202207113RINB
- Acronym
- HRS
- Status last verified
- Aug 2022
- First submitted
- 8 Jan 2023
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Technology-assisted Physical Therapy for Patient With High Risk of Sarcopenia
- ClinicalTrials.gov ID
- NCT05687630
- Acronym / sponsor ID
- HRS / 202207113RINB
- Conditions
- Sarcopenia
- Keywords
- sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 18 Jan 2023 (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.
This research aims to identify whether the effects of video-assisted physical therapy, including home resistance training, is superior to traditional physical therapy, education leaflet for example.
This is an interventional research, single-blind, randomized control trail. We recruit high risk of sarcopenia people (low muscle strength and low physical performance) Two groups of participants are divided into traditional group and video-assisted group, both group are taught the same resisted exercise by physical therapist.
Detailed description
Both group will record his/her baseline activity level with a given pedometer. After one week recording, we started initial evaluation (history taking, physical examination) and intervention.
Participants are taught thera-band resisted exercise, including large musculature of upper and lower extremities, each exercise are conducted 10-15 times for 3 sets.
Traditional group will receive an education leaflet and a notebook to record his/ her daily activity and frequency of exercise to record the compliance.
Video-assisted group will receive a QR code, which contain a website of exercise video on the cloud.
After 3 months intervention, participant will come back to our center for final examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-assisted group | Experimental | Other: elastic band resisted exercise |
| Traditional group | Active comparator | Other: elastic band resisted exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age above 65 years old
- MMSE > 24 points
- walking more than 6 meters independently
Key exclusion criteria (1 listed)
- people who cannot participate for 3 -day exercise for each week
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 |
|---|---|---|
| elastic band resisted exerciseAlso: resisted exercisemuscle strengthening exercise, 10-15 times of each set, for 3 sets | Other | Traditional group, Video-assisted group |
Primary outcome
Grip strength
Time frame: three months after initial evaluation
use hand dynamometer to test maximal strength
walking speed
Time frame: three months after initial evaluation
walk for 4 meters to test the time that participant used
Timed up-and-go test
Time frame: three months after initial evaluation
1 secondary outcome
Short Physical Performance Battery (SPPB)
Time frame: three months after initial evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Chen Yu Kuo, Bachelor principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing elastic band resisted exercise in people with Sarcopenia, run by National Taiwan University Hospital.
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 1 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 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Chen Yu Kuo, Bachelor (+886 988581069, 119271@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip strength (time frame: three months after initial evaluation). The study lists 3 primary outcomes in all. 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 18 Jan 2023.