NCT05832853

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

April 16, 2023

Last Update Submit

April 16, 2023

Conditions

Keywords

frailtyexercise intervention

Outcome Measures

Primary Outcomes (4)

  • 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

    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.

    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

    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.

    Month 6

Study Arms (3)

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.

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.

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.

Behavioral: Resistance training and endurance training

Interventions

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 exercise

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.

Wu Qin Xi, 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.

Resistance training and endurance training

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Center of Exercise Epidemiology

Changchun, Jilin, 130024, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Frailty

Interventions

Resistance TrainingEndurance Training

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

April 16, 2023

First Posted

April 27, 2023

Study Start

May 20, 2018

Primary Completion

December 30, 2018

Study Completion

January 30, 2019

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations