Effects of Home-Based Ankle Training Program on The Muscle Strength, Balance and Gait Function in the Elderly

NCT ID: NCT05790369

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-09

Study Completion Date

2023-01-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

New ankle machine training group (NAMTG)

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

Group Type EXPERIMENTAL

Resistance training (New ankle machine training)

Intervention Type BEHAVIORAL

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

Elastic band training group (EBTG)

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

Group Type ACTIVE_COMPARATOR

Resistance training (Elastic band training )

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Resistance training (New ankle machine training)

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

Intervention Type BEHAVIORAL

Resistance training (Elastic band training )

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hsiu-Chen Lin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

China Medical University

Taichung, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CMUH110-REC2-192

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.