SarcopeniaNCT04497480
The Extremities Rehabilitation Training System for Sarcopenic Hospitalized Aged 80+ Years
A study testing Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System in people with Sarcopenia, run by Yuxiang Liang at 1 site in China.
Trial summary
Most previous clinical trials that addressed the rehabilitation training system for sarcopenic elderly subjects focused on community-dwelling older adults who were relatively healthy. Read more about this study
- Who is it for?
- Ages 80 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2020to 1 Dec 2021
- 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 80 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Sarcopenia defined by the Asia Working Group of Sarcopenia (AWGS)
- Agree to participant this study and sign the informed consent
- Aged 80 years or over
Who cannot join
- Patients who could not follow the training plan due to cognitive impairment, emotional problems or any other reasons;
- Severe heart and lung diseases;
- Renal insufficiency;
- Any type of tumor;
- Bedridden patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital，Sichuan University
Chengdu, Sichuan, 610064
Yuxiang Liang, 0086-13982250862, yx45liang@sina.com
About this study
Official title: Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation System for Treating Sarcopenia in Hospitalized Patients Aged 80 Years and Older
Most previous clinical trials that addressed the rehabilitation training system for sarcopenic elderly subjects focused on community-dwelling older adults who were relatively healthy. There is a notable paucity of high-quality research investigating the effects and feasibility of the device for hospitalized or institutionalized older people, who are generally frailer and more severe in functional impairment than those living in the community. Moreover, most reported the system were of long-term duration, which typically lasted 3 to 6 months with two sessions per week. It remains unclear whether short-term the device training would be effective for treating sarcopenia. Therefore, the investigators aimed to assess the effectiveness of Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System for treating sarcopenia in hospitalized older patients aged 80 years and over.
- Conditions
- Sarcopenia
- Being tested
- Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training SystemBehavioural
The Passive, Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System is designed for patients confined to bed at the long-term care facilities hospitals, in early rehabilitation. This system can induce a natural movements of the upper/lower limb with safe motorized passive movement, as well as motor-assisted and active resistive muscle training to stimulate nerves, increase blood circulation of affected tissue, cell metabolism and improve joint mobility, in promoting upper/lower extremities motor recovery.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Behavioral: Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System |
| controlled group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of activities of daily living
Basic activities of daily living (BADL) assessed by Barthel Index
Measured: 3 Months
Secondary outcomes (1)
The change of handgrip strength
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start28 Jul 2020
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuxiang Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuxiang Liang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497480
- Sponsor's protocol ID
- 2020（001）
- Status last verified
- Sep 2021
- First submitted
- 29 Jul 2020
- Last updated
- 14 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation System for Treating Sarcopenia in Hospitalized Patients Aged 80 Years and Older
- ClinicalTrials.gov ID
- NCT04497480
- Acronym / sponsor ID
- 2020（001）
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yuxiang LiangUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 4 Aug 2020 (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.
Most previous clinical trials that addressed the rehabilitation training system for sarcopenic elderly subjects focused on community-dwelling older adults who were relatively healthy. There is a notable paucity of high-quality research investigating the effects and feasibility of the device for hospitalized or institutionalized older people, who are generally frailer and more severe in functional impairment than those living in the community. Moreover, most reported the system were of long-term duration, which typically lasted 3 to 6 months with two sessions per week. It remains unclear whether short-term the device training would be effective for treating sarcopenia. Therefore, the investigators aimed to assess the effectiveness of Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System for treating sarcopenia in hospitalized older patients aged 80 years and over.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System |
| controlled group | No intervention | – |
Who may qualify
- Ages
- 80 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Sarcopenia defined by the Asia Working Group of Sarcopenia (AWGS)
- Agree to participant this study and sign the informed consent
- Aged 80 years or over
Key exclusion criteria (5 listed)
- Patients who could not follow the training plan due to cognitive impairment, emotional problems or any other reasons;
- Severe heart and lung diseases;
- Renal insufficiency;
- Any type of tumor;
- Bedridden patients
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 |
|---|---|---|
| Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training SystemThe Passive, Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System is designed for patients confined to bed at the long-term care facilities hospitals, in early rehabilitation. This system can induce a natural movements of the upper/lower limb with safe motorized passive movement, as well as motor-assisted and active resistive muscle training to stimulate nerves, increase blood circulation of affected tissue, cell metabolism and improve joint mobility, in promoting upper/lower extremities motor recovery. | Behavioural | experimental group |
Primary outcome
The change of activities of daily living
Time frame: 3 Months
Basic activities of daily living (BADL) assessed by Barthel Index
1 secondary outcome
The change of handgrip strength
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System in people with Sarcopenia, run by Yuxiang Liang at 1 site in China.
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 5 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 14 Sep 2021. 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 China. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of activities of daily living (time frame: 3 Months). 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 14 Sep 2021.