Balance Ability of Older Women With a History of Falls (Balance)

July 31, 2024 updated by: Cheng Liang

Effect of Wuqinxi on the Balance Ability of Older Women With a History of Falls: A Randomized Controlled Trial

This study aims to investigate the effects of regular practice of Chinese fitness Qigong, Wuqinxi, on the balance ability of older women with a history of falls. Participants in the experimental group (n=35) and the control group (n=36), matched for age, height, and weight, were included in the study. The experimental group underwent a 24-week (3 times per week, 70 minutes per session) Wuqinxi exercise regimen. Changes in dynamic and static balance abilities of the participants were tested at weeks 0, 12, and 24. A 24-week Wuqinxi exercise regimen increased the static and dynamic balance abilities in both directions for older women with a history of falls. Compared to 12 weeks, a longer Wuqinxi exercise regimen further enhanced the static balance ability in the open-eye state.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Chengdu Sport University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
Other Names:
  • Control Group
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.
Other: 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.
Other Names:
  • Control Group
Other: 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.
Other Names:
  • Experimental group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cheng Liang

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yang Yi, Dr, Chengdu Sport University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Sichuan Fitness Qigong Center (Other Identifier: Chengdu Sport University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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