SarcopeniaNCT04355299
A Short-term Mixed Exercise for Sarcopenic Hospitalized Aged 80+ Years
A study testing balance training, resistance training and aerobic exercise in people with Sarcopenia, run by Yuxiang Liang.
Trial summary
Most previous clinical trials that addressed exercise 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 exercise for hospitalized or institutionalized older people, who… Read more about this study
- Who is it for?
- Ages 80 to 102 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- balance training, resistance training and aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 1 Jan 2020
- 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 102 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged ≥80 years;
- being able to ambulate (assistance was acceptable);
- being able to communicate and collaborate with the physiotherapist;
- with sarcopenia defined by the AWGS criteria ;
Who cannot join
- terminal illness;
- uncontrolled heart failure;
- myocardial infarction within the past three months;
- uncontrolled respiratory failure;
- bone fractures within the past three months;
- acute pulmonary embolism;
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- major surgery within the past three months;
- uncontrolled arrhythmia;
- refusal to participate in this study.
About this study
Official title: Effectiveness of a Short-term Mixed Exercise Program for Treating Sarcopenia in Hospitalized Patients Aged 80 Years and Older
Most previous clinical trials that addressed exercise 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 exercise 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 exercise programs were of long-term duration, which typically lasted 3 to 6 months with two sessions per week. It remains unclear whether short-term exercise would be effective for treating sarcopenia. Therefore, the investigators aimed to assess the effectiveness of short-term exercise for treating sarcopenia in hospitalized older patients aged 80 years and over.
- Conditions
- Sarcopenia
- Being tested
- balance training, resistance training, aerobic exercise, usual care
- 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.
aerobic exerciseBehavioural
Aerobic exercise is any activity that gets your blood pumping and large muscle groups working. It's also known as cardiovascular activity.
usual careBehavioural
received usual care
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | a mixed exercise program including aerobic, balance, and resistance exercises that were personally tailored. Receives: Behavioral: balance training; Behavioral: resistance training; Behavioral: aerobic exercise |
| control group | Other | usual care Receives: Behavioral: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of activities of daily living from the baseline to the end of the 2-week intervention
Basic activities of daily living (BADL) assessed by Barthel Index. The total score for Barthel Index ranges from 0 (worst) to 100 (best) points.
Measured: 2 weeks
Secondary outcomes (4)
The change of gait speed
Gait speed was measured using a 4-meter walking test.
Measured: 2 weeks
The change of handgrip strength
Handgrip strength was measured using a digital grip dynamometer
Measured: 2 weeks
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. The total score for SPPB ranges from 0 (worst) to 12 (best) points.
Measured: 2 weeks
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. The score for the TUG is the time consumption of the whole process. The longer time consuption indicates the more worse outcome.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Oct 2016
- Primary completion30 Dec 2019
- Study completion1 Jan 2020
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
- 121 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
- Jiaojiao Jiang, Principal investigator, West China HospitalMing Yang, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355299
- Sponsor's protocol ID
- 2019#611#
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 22 Apr 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 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Short-term Mixed Exercise Program for Treating Sarcopenia in Hospitalized Patients Aged 80 Years and Older
- ClinicalTrials.gov ID
- NCT04355299
- Acronym / sponsor ID
- 2019#611#
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Yuxiang LiangUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 21 Apr 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 exercise 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 exercise 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 exercise programs were of long-term duration, which typically lasted 3 to 6 months with two sessions per week. It remains unclear whether short-term exercise would be effective for treating sarcopenia. Therefore, the investigators aimed to assess the effectiveness of short-term exercise for treating sarcopenia in hospitalized older patients aged 80 years and over.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: balance training, Behavioral: resistance training, Behavioral: aerobic exercisea mixed exercise program including aerobic, balance, and resistance exercises that were personally tailored. |
| control group | Other | Behavioral: usual careusual care |
Who may qualify
- Ages
- 80 to 102 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- aged ≥80 years;
- being able to ambulate (assistance was acceptable);
- being able to communicate and collaborate with the physiotherapist;
- with sarcopenia defined by the AWGS criteria ;
Key exclusion criteria (9 listed)
- terminal illness;
- uncontrolled heart failure;
- myocardial infarction within the past three months;
- uncontrolled respiratory failure;
- bone fractures within the past three months;
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 | Intervention 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 | Intervention group |
| aerobic exerciseAerobic exercise is any activity that gets your blood pumping and large muscle groups working. It's also known as cardiovascular activity. | Behavioural | Intervention group |
| usual carereceived usual care | Behavioural | control group |
Primary outcome
The change of activities of daily living from the baseline to the end of the 2-week intervention
Time frame: 2 weeks
Basic activities of daily living (BADL) assessed by Barthel Index. The total score for Barthel Index ranges from 0 (worst) to 100 (best) points.
4 secondary outcomes
The change of gait speed
Time frame: 2 weeks
The change of handgrip strength
Time frame: 2 weeks
The change of the score of Short Physical Performance Battery
Time frame: 2 weeks
The change of the score of Timed Up and Go test
Time frame: 2 weeks
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 22 Apr 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.
Jiaojiao Jiang principal investigator
West China Hospital
Ming Yang study director
West China Hospital
Questions about this trial
What is this clinical trial studying?
A study testing balance training, resistance training and aerobic exercise in people with Sarcopenia, run by Yuxiang Liang.
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 4 inclusion and 9 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 22 Apr 2020. 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?
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?
The change of activities of daily living from the baseline to the end of the 2-week intervention (time frame: 2 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 22 Apr 2020.