Frail Elderly SyndromeNCT05832853
A Study of the Intervention Effect of a Hybrid Exercise Program on Frail Elderly
A study testing Wu Qin Xi exercise, Wu Qin Xi, resistance training and endurance training and Resistance training and endurance training in people with Frail Elderly Syndrome, run by Guang Yang, Prof. Dr. at 1 site in China.
Trial summary
The declining physical condition of frail elderly is becoming an ugent problem. Although the exercise intensity of Wu Qin Xi appears to be low, it is highly effective in the older individuals. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Wu Qin Xi exercise, Wu Qin Xi, resistance training and endurance training and Resistance training and endurance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2018to 30 Jan 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a Fried frailty phenotype score of 3-5 points;
- could walk for at least 6 min without support;
- had not been able to walk in the past year other training.
Who cannot join
- people who have a past mental illness or serious psychological issues which make it difficult to obey orders;
- people who have had neurological disorders within the last six months;
- people who must regularly participate in other training programs during the study period;
- people who struggle to walk normally due to significant muscle and skeletal injuries and continuous joint discomfort.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hybrid Exercise Program is Frail Elderly Need: Effectiveness on the Physical Abilities and Clinical Assistance From White Box Modeling
The declining physical condition of frail elderly is becoming an ugent problem. Although the exercise intensity of Wu Qin Xi appears to be low, it is highly effective in the older individuals. Inspired by the characteristics and functions of Wu Qin Xi, we designed a brand new exercise intervention training program among frail older people, which incorporates Wu Qin Xi, strength exercises and endurance exercises to improve physical fitness, and even reverse the condition of frailty. Furthermore, to improve utility in clinical practice, we innovatively employed machine learning simulations to infer the condition of older adults and predict their level of frailty after the intervention.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Wu Qin Xi exercise, Wu Qin Xi, resistance training and endurance training, Resistance training and endurance training
- Keywords
- frailty, exercise intervention
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wu Qin Xi exerciseBehavioural
The training schedule for Wu Qin Xi consisted of two phases: the first phase lasted for eight weeks, while the second phase lasted for 16 weeks. In the first phase, Wu Qin Xi group was given twice repetitions of the intervention. The second phase consisted of three repetitions of the Wu Qin Xi group. Participants warmed up for 20 min prior to the intervention and cooled down for 10 min at the end.
Wu Qin Xi, resistance training and endurance trainingBehavioural
During the first 8 weeks, the training consists of learning and consolidating the movements of the Wu Qin Xi. In the second 16 weeks, participants perform a full set of movement exercises. Each resistance training session contained two lower-body exercises (seated calf raises and hip abduction) and three upper-body exercises (lateral pull downs, biceps curls, and triceps push downs) and two sets for each exercise. Endurance training is performed by continuous walking on an undisturbed indoor track for 15 min. Participants warmed up for 20 min prior to the intervention and cooled down for 10 min at the end.
Resistance training and endurance trainingBehavioural
Each resistance training session contained two lower-body exercises (seated calf raises and hip abduction) and three upper-body exercises (lateral pull downs, biceps curls, and triceps push downs) and three sets for each exercise. Endurance training is performed by continuous walking on an undisturbed indoor track for 30 min. Participants warmed up for 20 min prior to the intervention and cooled down for 10 min at the end.
| Study group | Role | What they receive |
|---|---|---|
| Wu Qin Xi exercise | Experimental | The training schedule for Wu Qin Xi consisted of two phases: the first phase lasted for eight weeks, while the second phase lasted for 16 weeks. In the first phase, Wu Qin Xi group was given twice repetitions of the intervention. The second phase consisted of three repetitions of the Wu Qin Xi group. Receives: Behavioral: Wu Qin Xi exercise |
| Wu Qin Xi, resistance training and endurance training | Experimental | The trial was divided into three cycles, each lasting eight weeks. Participants performed a hybrid program of Wu Qin Xi exercise, resistance training and endurance training of varying duration and intensity in each cycle. Each session lasted one hour, three times a week for 24 weeks. Receives: Behavioral: Wu Qin Xi, resistance training and endurance training |
| Resistance training and endurance training | Experimental | The trial was divided into three cycles, each lasting eight weeks. Participants performed a hybrid program of resistance training and endurance training of varying duration and intensity in each cycle. Each session lasted one hour, three times a week for 24 weeks. Receives: Behavioral: Resistance training and endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the endurance of frail older adults using the six-minute walk test
Assessment of endurance in frail older adults before and after intervention using the six-minute walk test
Measured: Month 6
Assessing the speed of frail older adults using the ten-meter maximum walk speed
Assessment of speed in frail older adults before and after intervention using ten-meter maximum walk speed.
Measured: Month 6
Using handgrip strength tests to assess strength in frail older adults.
Using handgrip strength tests to assess strength in frail older adults before and after intervention
Measured: Month 6
Assessment of balance in frail older adults using Time Up and Go Test.
Assessment of balance in frail older adults before and after intervention using Time Up and Go Test.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start20 May 2018
- Primary completion30 Dec 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang Yang, Prof. Dr.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guang Yang, Prof. Dr., Northeast Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832853
- Sponsor's protocol ID
- CCEE2018
- Status last verified
- Apr 2023
- First submitted
- 16 Apr 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wei M, He S, Meng D, Yang G, Wang Z. Hybrid Exercise Program Enhances Physical Fitness and Reverses Frailty in Older Adults: Insights and Predictions from Machine Learning. J Nutr Health Aging. 2023;27(10):894-902. doi: 10.1007/s12603-023-1991-0.
PubMed 37960913
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Exercise Program is Frail Elderly Need: Effectiveness on the Physical Abilities and Clinical Assistance From White Box Modeling
- ClinicalTrials.gov ID
- NCT05832853
- Acronym / sponsor ID
- CCEE2018
- Conditions
- Frail Elderly Syndrome
- Keywords
- frailty, exercise intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Guang Yang, Prof. Dr.University, hospital or other
- Study start
- 20 May 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 27 Apr 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.
The declining physical condition of frail elderly is becoming an ugent problem. Although the exercise intensity of Wu Qin Xi appears to be low, it is highly effective in the older individuals. Inspired by the characteristics and functions of Wu Qin Xi, we designed a brand new exercise intervention training program among frail older people, which incorporates Wu Qin Xi, strength exercises and endurance exercises to improve physical fitness, and even reverse the condition of frailty. Furthermore, to improve utility in clinical practice, we innovatively employed machine learning simulations to infer the condition of older adults and predict their level of frailty after the intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wu Qin Xi exercise | Experimental | Behavioral: Wu Qin Xi exerciseThe training schedule for Wu Qin Xi consisted of two phases: the first phase lasted for eight weeks, while the second phase lasted for 16 weeks. In the first phase, Wu Qin Xi group was given twice repetitions of the intervention. The second phase consisted of three repetitions of the Wu Qin Xi group. |
| Wu Qin Xi, resistance training and endurance training | Experimental | Behavioral: Wu Qin Xi, resistance training and endurance trainingThe trial was divided into three cycles, each lasting eight weeks. Participants performed a hybrid program of Wu Qin Xi exercise, resistance training and endurance training of varying duration and intensity in each cycle. Each session lasted one hour, three times a week for 24 weeks. |
| Resistance training and endurance training | Experimental | Behavioral: Resistance training and endurance trainingThe trial was divided into three cycles, each lasting eight weeks. Participants performed a hybrid program of resistance training and endurance training of varying duration and intensity in each cycle. Each session lasted one hour, three times a week for 24 weeks. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a Fried frailty phenotype score of 3-5 points;
- could walk for at least 6 min without support;
- had not been able to walk in the past year other training.
Key exclusion criteria (4 listed)
- people who have a past mental illness or serious psychological issues which make it difficult to obey orders;
- people who have had neurological disorders within the last six months;
- people who must regularly participate in other training programs during the study period;
- people who struggle to walk normally due to significant muscle and skeletal injuries and continuous joint discomfort.
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 |
|---|---|---|
| Wu Qin Xi exerciseThe training schedule for Wu Qin Xi consisted of two phases: the first phase lasted for eight weeks, while the second phase lasted for 16 weeks. In the first phase, Wu Qin Xi group was given twice repetitions of the intervention. The second phase consisted of three repetitions of the Wu Qin Xi group. Participants warmed up for 20 min prior to the intervention and cooled down for 10 min at the end. | Behavioural | Wu Qin Xi exercise |
| Wu Qin Xi, resistance training and endurance trainingDuring the first 8 weeks, the training consists of learning and consolidating the movements of the Wu Qin Xi. In the second 16 weeks, participants perform a full set of movement exercises. Each resistance training session contained two lower-body exercises (seated calf raises and hip abduction) and three upper-body exercises (lateral pull downs, biceps curls, and triceps push downs) and two sets for each exercise. Endurance training is performed by continuous walking on an undisturbed indoor track for 15 min. Participants warmed up for 20 min prior to the intervention and cooled down for 10 min at the end. | Behavioural | Wu Qin Xi, resistance training and endurance training |
| Resistance training and endurance trainingEach resistance training session contained two lower-body exercises (seated calf raises and hip abduction) and three upper-body exercises (lateral pull downs, biceps curls, and triceps push downs) and three sets for each exercise. Endurance training is performed by continuous walking on an undisturbed indoor track for 30 min. Participants warmed up for 20 min prior to the intervention and cooled down for 10 min at the end. | Behavioural | Resistance training and endurance training |
Primary outcome
Assessing the endurance of frail older adults using the six-minute walk test
Time frame: Month 6
Assessment of endurance in frail older adults before and after intervention using the six-minute walk test
Assessing the speed of frail older adults using the ten-meter maximum walk speed
Time frame: Month 6
Assessment of speed in frail older adults before and after intervention using ten-meter maximum walk speed.
Using handgrip strength tests to assess strength in frail older adults.
Time frame: Month 6
Using handgrip strength tests to assess strength in frail older adults before and after intervention
Assessment of balance in frail older adults using Time Up and Go Test.
Time frame: Month 6
Assessment of balance in frail older adults before and after intervention using Time Up and Go Test.
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 27 Apr 2023.
- Derived from this study: PubMed 37960913Wei M, He S, Meng D, Yang G, Wang Z. Hybrid Exercise Program Enhances Physical Fitness and Reverses Frailty in Older Adults: Insights and Predictions from Machine Learning. J Nutr Health Aging. 2023;27(10):894-902. doi: 10.1007/s12603-023-1991-0.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wu Qin Xi exercise, Wu Qin Xi, resistance training and endurance training and Resistance training and endurance training in people with Frail Elderly Syndrome, run by Guang Yang, Prof. Dr. 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 4 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 27 Apr 2023. 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?
Assessing the endurance of frail older adults using the six-minute walk test (time frame: Month 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05832853, which also lists 1 linked publication.
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 27 Apr 2023.