A Study of the Intervention Effect of a Hybrid Exercise Program on Frail Elderly

April 16, 2023 updated by: Guang Yang, Prof. Dr.

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.

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.

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.
181

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
    • Jilin
      • Changchun, Jilin, China, 130024
        • Chinese Center of Exercise Epidemiology

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

No

Description

Inclusion Criteria:

  1. a Fried frailty phenotype score of 3-5 points;
  2. could walk for at least 6 min without support;
  3. had not been able to walk in the past year other training.

Exclusion Criteria:

  1. people who have a past mental illness or serious psychological issues which make it difficult to obey orders;
  2. people who have had neurological disorders within the last six months;
  3. people who must regularly participate in other training programs during the study period;
  4. people who struggle to walk normally due to significant muscle and skeletal injuries and continuous joint discomfort.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
Experimental: Wu Qin Xi exercise
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.
Behavioral: Wu Qin Xi exercise
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.
Experimental: Wu Qin Xi, resistance training and endurance training
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.
Behavioral: Wu Qin Xi, resistance training and endurance training
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.
Experimental: Resistance training and endurance training
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.
Behavioral: Resistance training and endurance training
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.

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
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
Month 6
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.
Month 6
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
Month 6
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.
Month 6

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.
Guang Yang, Prof. Dr.

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.
May 20, 2018

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.
December 30, 2018

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.
January 30, 2019

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).
April 16, 2023

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.
April 16, 2023

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.
April 27, 2023

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.
April 27, 2023

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.
April 16, 2023

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.
April 1, 2023

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.
  • CCEE2018

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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