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

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • 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

    • 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

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
Intervention / Treatment
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.
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.
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.
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

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.

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)

May 20, 2018

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

January 30, 2019

Study Registration Dates

First Submitted

April 16, 2023

First Submitted That Met QC Criteria

April 16, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 16, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID 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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