NCT06358170

Brief Summary

According to the cause of death statistics compiled by the Ministry of Health and Welfare in 2022, among the causes of death among the elderly, falls ranked second among the causes of death from accidental injuries over the age of 65. Exercise has been proven to prevent falls in many studies, especially Square-Stepping Exercise can not only train strength and balance, but also improve cognitive function and reduce the fear of falling in the elderly. Therefore, this study will use Square-Stepping Exercise as the core and circuit training as the structure to design a set of exercise training that combines muscle strength and balance and is easy to implement in the community. The purpose of the study is to determine whether exercise training that combines circuit training with block stepping, muscle strength, and balance exercises can reduce the risk of falls among elderly people in the community (primary results: muscle strength, flexibility, cardiorespiratory endurance, balance; secondary results: cognitive function, Fear of falling, fall rate). This study will collect participant in the community, and subjects will be randomly assigned to the experimental group and the control group on a community basis. The experimental group will receive 12 weeks of exercise training, while the control group will follow their usual lifestyle, with 48 people in each group. The experimental design is exercise intervention for 12 weeks, twice a week, 90 minutes each time (30 minutes of main exercise). The exercise is designed into two stages according to the difficulty of Square-Stepping Exercise. The training of muscle strength and dynamic/static balance will also gradually increase in difficulty over the weeks. The research look forward to seeing the effects of multi-component exercise on physical fitness, cognitive function, fear of falling and fall rate.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 1, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

March 24, 2024

Last Update Submit

April 6, 2024

Conditions

Keywords

communityelderly peoplefallsfall preventionSquare-Stepping Exercisecircuit trainingexercise trainingphysical fitnesscognitive functionfear of falling

Outcome Measures

Primary Outcomes (7)

  • Senior Fitness - upper body muscle strength (Arm Curl Test)

    As the arm is lowered through the full range of motion, gradually return to the starting position. The arm must be fully bent and then fully straightened at the elbow. Repeat this action as many times as possible within 30 seconds.

    30 seconds

  • Senior Fitness - lower body muscle strength (Chair Stand Test )

    From the sitting position, the subject stands completely up, then completely back down, and this is repeated for 30 seconds. Count the total number of complete chair stands (up and down equals one stand).

    30 seconds

  • Senior Fitness - upper body flexibility (Back Scratch Test)

    Place one hand behind the head and back over the shoulder, and reach as far as possible down the middle of your back, your palm touching your body and the fingers directed downwards. Place the other arm behind your back, palm facing outward and fingers upward and reach up as far as possible attempting to touch or overlap the middle fingers of both hands. An assistant is required to direct the subject so that the fingers are aligned, and to measure the distance between the tips of the middle fingers. If the fingertips touch then the score is zero. If they do not touch, measure the distance between the finger tips (a negative score), if they overlap, measure by how much (a positive score).

    5 seconds

  • Senior Fitness - lower body flexibility (Chair Sit and Reach Test)

    The subject should sit on the edge a chair (placed against a wall for safety). One foot must remain flat on the floor. The other leg is extended forward with the knee straight, heel on the floor, and ankle bent at 90°. Place one hand on top of the other with tips of the middle fingers even. Keep the knee straight, and hold the reach for 2 seconds. The distance is measured between the tip of the fingertips and the toes. If the fingertips touch the toes then the score is zero. If they do not touch their toes, measure the distance between the fingers and the toes (a negative score), if they overlap, measure by how much (a positive score). Perform two trials.

    5 seconds

  • Senior Fitness - cardio respiratory endurance ( 2 Minute Step in Place Test)

    The subject stands up straight next to the wall while a mark is placed on the wall at the level corresponding to midway between the patella (knee cap) and illiac crest (top of the hip bone). The subject then marches in place for two minutes, lifting the knees to the height of the mark on the wall. Stop after two minutes of stepping.

    2 minutes

  • Senior Fitness - dynamic balance (8-Foot Up and Go Test)

    Place the chair next to a wall (for safety) and the marker 8 feet in front of the chair. Clear the path between the chair and the marker. The subject starts fully seated, hands resting on the knees and feet flat on the ground. On the command, "Go," timing is started and the subject stands and walks (no running) as quickly as possible (and safely) to and around the cone, returning to the chair to sit down. Timing stops as they sit down. Perform two trials.

    10 seconds

  • Senior Fitness - static balance (Single-Leg Balance with Eyes Open)

    Performed with eyes open and hands on the hips. Stands on one leg unassisted; time begins when opposite foot leaves the ground; time stops immediately when opposite foot touches the ground and/or when hands leave the hips. 30 seconds is the best time, if it exceeds 30 seconds, it will be scored as 30 seconds.

    30 seconds

Secondary Outcomes (3)

  • cognitive function

    7 minutes

  • Fear of falling

    2 minutes

  • fall rate

    30 seconds

Study Arms (2)

SSE

EXPERIMENTAL

A Circuit Training Combine with Square-Stepping Exercise, Strength training and balance training. The intervention time and frequency of this study were 12 weeks, 2 times a week, 24 times in total, 1.5 hours each time (30 minutes of main exercise).

Behavioral: Circuit Training Combine with Square-Stepping Exercise

Control

NO INTERVENTION

No intervention (daily routine)

Interventions

Circuit Training Combine with Square-Stepping Exercise

SSE

Eligibility Criteria

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

You may qualify if:

  • Aged 60 years or older.
  • Determine no exercise risk via ACSM's PAR-Q+ (The Physical Activity Readiness Questionnaire for everyone).
  • SPPB (Short Physical Performance Battery) score of 10 or above indicates normal mobility.
  • Will not participate in other physical exercise programs after starting this program.

You may not qualify if:

  • Those who are unable to complete the assessment process (due to hearing, vision, etc.) or participate due to limited mobility problems.
  • Those whose cognitive function cannot cooperate with the assessment process.
  • Those whose attendance rate is less than 80%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

March 24, 2024

First Posted

April 10, 2024

Study Start

March 1, 2024

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

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