NCT05790369

Brief Summary

The occurrence of frequent falls influences the independence of the elderly's physical functions, and the factors related to falls include: weakness in the lower limbs, age, past injury experiences and so forth. Prolonged inactivity also increases the risk of falls, which is subsequently prone to bringing about other complications, which enhances the odds of falling again on the elderly. In the literature, training methods for the lower limbs were for the most part of complex training, whereas only a few studied on the single part training. In locomotion, the ankle first touches the ground, needing strong ankle muscular strength to support the body. Nevertheless, previous studies rarely mentioned whether a single ankle muscular strength could reduce the risk of falls. Traditionally, the training of ankle muscular strength practically utilizes elastic bands, and there are plenty of benefits confirmed in the literature. However, it is even harder to implement the operation in reality, especially in the elderly. To resolve this problem effectively, a new type of ankle training machine is added to this study. It can be adjusted to different levels of resistance, provide multi directional training, and allow the subjects to be trained in a sitting position achieving a stable state. In addition, this machine is easy to operate for the elderly. The aims of this research are: (1) to propose two different types of ankle training methods and designed a 6 week training programs, (2) to explore whether the training programs can improve muscular strength, balance capacity and gait function and (3) compare the training effects between the two types of ankle training methods. In this study, 60 voluntary old citizens, aged over 65, will be recruited, and they will be randomly divided into: 30 members in the Elastic Band Training Group (EBTG) and 30 members in the New Ankle Training Machine Training Group (NAMTG). During the six week workout plan, the subjects receive on site or online guidance from professional coaches every two weeks; meanwhile, coaches can affirm whether the plan is executed properly, confirming the effectiveness of the home training. Through these two groups of home ankle training programs with different interventional approaches lasting six weeks, the objective of the intervention is to boost muscular strength, balance ability as well as gait ability, meanwhile to decline the risk of falls and to reduce high medical expenses and care labor costs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

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

December 9, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

October 20, 2022

Last Update Submit

May 10, 2023

Conditions

Keywords

Ankle strengthening trainingMuscular strengthBalance abilityGait functionElderly

Outcome Measures

Primary Outcomes (4)

  • Muscle strength test

    Sit-to-stand test, recoding by the time in seconds

    Change from Baseline (before the training) at the completion of 6 weeks training

  • Postural stability test

    One-leg standing with eye-open and eye-closed, recoding by the the center of pressure from a force plate

    Change from Baseline (before the training) at the completion of 6 weeks training

  • Y- balance test

    Recoding the distance in the anterior, posterio-medial and posterio-lateral in cm.

    Change from Baseline (before the training) at the completion of 6 weeks training

  • Gait analysis

    Recoding the joint angle in degrees by the IMU sensors.

    Change from Baseline (before the training) at the completion of 6 weeks training

Study Arms (2)

New ankle machine training group (NAMTG)

EXPERIMENTAL

home-based ankle training program consisted of 6 exercises for their general physical fitness and use a device (new ankle machine) to provide progressive resisted exercise for the ankle strength

Behavioral: Resistance training (New ankle machine training)

Elastic band training group (EBTG)

ACTIVE COMPARATOR

home-based ankle training program consisted of 6 exercises for their general physical fitness and use Thera band to provide progressive resisted exercise for the ankle strength

Behavioral: Resistance training (Elastic band training )

Interventions

A six week workout plan, the subjects receive on site or online guidance from professional coaches every two weeks.

New ankle machine training group (NAMTG)

A six week workout plan, the subjects receive on site or online guidance from professional coaches every two weeks.

Elastic band training group (EBTG)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Healthy elderly people over 65 years old have no exercise habits.
  • The ability to walk independently or without equipment is at least 10m.
  • Able to independently perform activities related to daily life, such as doing housework, walking, climbing stairs, etc.
  • Elderly people who have a history of minor stroke or upper limb surgery but have not affected the ankle movement can be included in the scope of the case.

You may not qualify if:

  • There is a musculoskeletal system disease, or the movement of the limbs is severely restricted.
  • If there is a history of lower limb surgery, which affects neurological symptoms and mobility, it is excluded.
  • Exclude specific diseases, such as stroke, spinal cord injury,etc., who have obvious sequelae of movement.
  • Participated in other programs including Muscular strength, Balance ability, Gait function training, etc. in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, 40402, Taiwan

Location

MeSH Terms

Interventions

Resistance Training

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
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 20, 2022

First Posted

March 30, 2023

Study Start

December 9, 2021

Primary Completion

January 8, 2023

Study Completion

January 8, 2023

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations