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

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Behavioral: Resistance training (New ankle machine training); Behavioral: Resistance training (Elastic band training )

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung City, Taiwan, 40402
    • China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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.
Active Comparator: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Actual): January 8, 2023
• Study Completion (Actual): January 8, 2023

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; Muscular strength; Balance ability; Ankle strengthening training; Gait function
• Other Study ID Numbers: CMUH110-REC2-192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No