- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06534099
Balance Ability of Older Women With a History of Falls (Balance)
Effect of Wuqinxi on the Balance Ability of Older Women With a History of Falls: A Randomized Controlled Trial
Study Overview
Detailed Description
The Wuqinxi exercise regimen was conducted under the guidance of a professional Wuqinxi instructor, where the experimental group practiced the five animal forms of the exercise, which include the Tiger, Deer, Bear, Ape, and Bird forms. The exercise period was 24 weeks, with the first 4 weeks designated as the learning phase and weeks 5 to 24 as the consolidation and reinforcement phase. The frequency of exercise was three times per week, with each session lasting 70 minutes, including 10 minutes for warm-up and relaxation activities. Participants practiced to fixed voice prompts and musical rhythms, completing four full sets of Wuqinxi movements, each set taking approximately 14 minutes with a 1-minute interval in between. Following the research design of Cheng et al, after completing each set of movements, participants immediately pressed on the radial artery to test the pulse beats for 10 seconds and reported their heart rate per minute to the experimenters. The exercise intensity was controlled within the range of (220 - age) x (55% to 65%). Participants were allowed to take a break if their heart rate was too high. Additionally, without changing their original lifestyle habits, weekly follow-ups were conducted by the experimenters via telephone or face-to-face interviews to ensure that the participants did not engage in other forms of regular fitness activities.
Compliance with the exercise regimen was managed through the following methods: regular supervision, with professional staff overseeing the training to ensure participants followed the set plan; completion of training logs, requiring participants to record detailed information about each training session, including content, duration, and intensity; and regular follow-ups, maintaining contact with participants through phone calls, WeChat, or face-to-face meetings to understand their training status and provide necessary support.
The balance ability tests were conducted on three occasions: at baseline, at the 12th week, and at the 24th week. The Good Balance balance testing device, manufactured in Finland, was used for all participants, which has been demonstrated to have good reliability and validity. Both static and dynamic balance tests were conducted with participants standing on the test platform using a stopwatch to measure the time that participants could stand on one leg with eyes open and closed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sichuan
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Chengdu, Sichuan, China, 610041
- Chengdu Sport University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Female, aged between 60 and 70 years
- At least one accidental fall within the past year
- Undergone a physical examination for cardiac function
- Have the intention to exercise and are able to complete the entire experimental process
- In compliance with the Declaration of Helsinki and have signed an informed consent form.
Exclusion criteria:
- Regular exercise habits through other means within the past 6 months
- Foot deformity, abnormal gait
- A history of severe lower limb trauma
- Epilepsy, motor disorders
- Cardiovascular diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
Without changing their original lifestyle habits, weekly follow-ups were conducted by the experimenters via telephone or face-to-face interviews to ensure that the participants did not engage in other forms of regular fitness activities.
|
Without changing their original lifestyle habits, weekly follow-ups were conducted by the experimenters via telephone or face-to-face interviews to ensure that the participants did not engage in other forms of regular fitness activities.
Other Names:
|
|
Experimental: Experimental
The Wuqinxi exercise regimen was conducted under the guidance of a professional Wuqinxi instructor, where the experimental group practiced the five animal forms of the exercise, which include the Tiger, Deer, Bear, Ape, and Bird forms.
The exercise period was 24 weeks, with the first 4 weeks designated as the learning phase and weeks 5 to 24 as the consolidation and reinforcement phase.
The frequency of exercise was three times per week, with each session lasting 70 minutes, including 10 minutes for warm-up and relaxation activities.
|
Without changing their original lifestyle habits, weekly follow-ups were conducted by the experimenters via telephone or face-to-face interviews to ensure that the participants did not engage in other forms of regular fitness activities.
Other Names:
The Wuqinxi exercise regimen was conducted under the guidance of a professional Wuqinxi instructor, where the experimental group practiced the five animal forms of the exercise, which include the Tiger, Deer, Bear, Ape, and Bird forms.
The exercise period was 24 weeks, with the first 4 weeks designated as the learning phase and weeks 5 to 24 as the consolidation and reinforcement phase.
The frequency of exercise was three times per week, with each session lasting 70 minutes, including 10 minutes for warm-up and relaxation activities.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance Ability Testing
Time Frame: 24 weeks
|
The balance ability tests were conducted on three occasions: at baseline, at the 12th week, and at the 24th week.
The Good Balance balance testing device, manufactured in Finland, was used for all participants, which has been demonstrated to have good reliability and validity.
Both static and dynamic balance tests were conducted with participants standing on the test platform using a stopwatch to measure the time that participants could stand on one leg with eyes open and closed.
|
24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yang Yi, Dr, Chengdu Sport University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Sichuan Fitness Qigong Center (Other Identifier: Chengdu Sport University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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