SarcopeniaNCT04216368
Balance Trainning for Sarcopenic Inpatients Aged 80+ Years
A study testing balance training and resistance training in people with Sarcopenia, run by Yuxiang Liang at 1 site in China.
Trial summary
Resistance training and aerobic exercise have been recommended for sarcopenic patients. However, whether balance training would further benefit for sarcopenic patients on the basis of resistance training and aerobic exercise remains unclear. Read more about this study
- Who is it for?
- Ages 80 to 99 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- balance training and resistance training
- 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
- 1 Jun 2017to 1 Nov 2019
- 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 99 years
- All sexes
- No healthy volunteers
- 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.
About this study
Official title: Effect of Balance Training on Mobility and Activities of Daily Living in Sarcopenic Inpatients Aged 80+Years
Resistance training and aerobic exercise have been recommended for sarcopenic patients. However, whether balance training would further benefit for sarcopenic patients on the basis of resistance training and aerobic exercise remains unclear. The purpose of this study is to explore the effect of balance training on improving the mobility of elderly patients with sarcopenia. Balance training involves doing exercises that strengthen the muscles that help keep the aged upright, including the legs and core. These kinds of exercises can improve stability and help prevent falls.
- Conditions
- Sarcopenia
- Being tested
- balance training, resistance training
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance trainingBehavioural
The training to improve balance is to work on the core muscle groups that help to maintain your posture.,and increase muscular strength.
resistance trainingBehavioural
Resistance training is a form of exercise that improves muscular strength and endurance. During a resistance training workout, you move your limbs against resistance provided by your body weight, gravity, bands, weighted bars or dumbbells.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Behavioral: balance training; Behavioral: resistance training |
| controlled group | Other | Not described Receives: Behavioral: resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall rates
The incidence of falls during the first year of follow-up
Measured: One year
The change of activities of daily living
Basic activities of daily living (BADL) assessed by Barthel Index
Measured: 3 Months
Secondary outcomes (4)
The change of usual gait speed
Measured: 3 months
The change of handgrip strength
Measured: 3 months
The change of the score of Short Physical Performance Battery
The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.
Measured: 3 Months
The change of the score of Timed Up and Go test
The Timed Up and Go test (TUG) is a simple test used to measure basic functional mobility and safety with mobility.
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 posted2 Jan 2020
- Study start1 Jun 2017
- Primary completion1 Jul 2019
- Study completion1 Nov 2019
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuxiang Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuxiang Liang, West China Hospital
- Investigators
- Ming Yang, Study director, West China HospitalJiaojiao Jiang, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216368
- Sponsor's protocol ID
- 2019（596）
- Status last verified
- Feb 2020
- First submitted
- 31 Dec 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Balance Training on Mobility and Activities of Daily Living in Sarcopenic Inpatients Aged 80+Years
- ClinicalTrials.gov ID
- NCT04216368
- Acronym / sponsor ID
- 2019（596）
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuxiang LiangUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 2 Jan 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.
Resistance training and aerobic exercise have been recommended for sarcopenic patients. However, whether balance training would further benefit for sarcopenic patients on the basis of resistance training and aerobic exercise remains unclear. The purpose of this study is to explore the effect of balance training on improving the mobility of elderly patients with sarcopenia. Balance training involves doing exercises that strengthen the muscles that help keep the aged upright, including the legs and core. These kinds of exercises can improve stability and help prevent falls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: balance training, Behavioral: resistance training |
| controlled group | Other | Behavioral: resistance training |
Who may qualify
- Ages
- 80 to 99 years
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| balance trainingThe training to improve balance is to work on the core muscle groups that help to maintain your posture.,and increase muscular strength. | Behavioural | experimental group |
| resistance trainingResistance training is a form of exercise that improves muscular strength and endurance. During a resistance training workout, you move your limbs against resistance provided by your body weight, gravity, bands, weighted bars or dumbbells. | Behavioural | controlled group, experimental group |
Primary outcome
Fall rates
Time frame: One year
The incidence of falls during the first year of follow-up
The change of activities of daily living
Time frame: 3 Months
Basic activities of daily living (BADL) assessed by Barthel Index
4 secondary outcomes
The change of usual gait speed
Time frame: 3 months
The change of handgrip strength
Time frame: 3 months
The change of the score of Short Physical Performance Battery
Time frame: 3 Months
The change of the score of Timed Up and Go test
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Ming Yang study director
West China Hospital
Jiaojiao Jiang principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balance training and resistance training 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: finished, as of the sponsor's last update on 13 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall rates (time frame: One year). The study lists 2 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 13 Feb 2020.