Foot Core Exercise Program on Balance Control and Walking in Aged Sarcopenia

NCT ID: NCT05750888

Last Updated: 2023-03-02

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-30

Study Completion Date

2023-07-31

Brief Summary

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In modern society with an increasing aging population, recent literature has defined sarcopenia as a significant reduced mass and function of skeletal muscle with physical limitations due to aging. Clinically and experimentally, the foot often plays a crucial role in sensorimotor control and movement performance in standing, walking, and running. Apparently, previous literature has shown that the intrinsic and extrinsic foot muscles have significantly reduced muscle morphology and muscle strength in the elderly compared to that of young healthy controls. How to effectively increase foot muscles using muscle-strengthening exercises will be a crucial issue for further research and clinical intervention in this population.

The intrinsic foot muscles (IFM) are the primary local stabilizer to provide static and dynamic stability in the foot, which are part of the active and neural subsystems to constitute the foot core system. The intrinsic foot muscles (IFMs) may play a key role in supporting foot arches (e.g., the medial longitudinal arch, MLA), providing flexibility, stability, shock absorption to the foot, and partially controlling foot pronation. Due to the difficulties in teaching and learning the plantar intrinsic foot muscle (IFM) exercise, the accuracy and follow-up after learning this exercise could be questioned following this exercise program. Physiologically, the effects of integrated exercise intervention may be achieved following more than 4-week intensive exercise intervention at least. How to learn and activate this kind of exercise efficiently and effectively is a key issue for employing these exercise interventions in the elderly with and without sarcopenia.

In this project, we will aim to employ the novel intrinsic foot muscle strengthening device using 3-D printing techniques and to examine the feasibility and reliability of the morphology in intrinsic and extrinsic foot muscles and foot posture before and after exercise intervention using sonographic imaging and foot posture index in the elderly with and without sarcopenia; second, we will investigate whether the immediate and persistent increase in balance control and level-walking after this therapeutic exercise with novel 3-D printing foot core exerciser.

Detailed Description

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In modern society with an increasing aging population, Asian Working Groups for Sarcopenia (AWSG) has defined sarcopenia as a significantly reduced mass and function of skeletal muscle with physical limitations due to aging. The prevalence in the globe has reported 5% - 25.7% of the elderly population and its associations are very high between daily activity limitations, physical limitations, and premature death. Clinically and experimentally, the foot often plays a crucial role in sensorimotor control and movement performance in standing, walking, and running. Apparently, previous literature has shown that the intrinsic and extrinsic foot muscles have significantly reduced muscle morphology and muscle strength in the elderly compared to that of young healthy controls. How to effectively increase foot muscles using muscle-strengthening exercises will be a crucial issue for further research and clinical intervention in this population.

Anatomically, the intrinsic foot muscles (IFM) are the primary local stabilizer to provide static and dynamic stability in the foot, which are part of the active and neural subsystems to constitute the foot core system. The intrinsic foot muscles (IFMs) may play a key role in supporting foot arches (e.g. the medial longitudinal arch, MLA), providing flexibility, stability, shock absorption to the foot, and partially controlling foot pronation. Due to the difficulties in teaching and learning the plantar intrinsic foot muscle (IFM) exercise, the accuracy and follow-up after learning this exercise could be questioned following this exercise program; Physiologically, the effects of integrated exercise intervention may be achieved following more than 4-week intensive exercise intervention at least. How to learn and activate this kind of exercise efficiently and effectively is a key issue for employing these exercise interventions in the elderly with and without sarcopenia.

This project consists of two main parts - first, we will aim to employ the novel intrinsic foot muscle strengthening device using 3-D printing techniques and to examine the feasibility and reliability of the morphology in intrinsic and extrinsic foot muscles and foot posture before and after exercise intervention using sonographic imaging and foot posture index in the elderly with and without sarcopenia; second, we will investigate whether the immediate and persistent increase in balance control and level-walking after this therapeutic exercise with novel 3-D printing foot core exerciser. More importantly, we elucidate important clinical evidence-based information of long-term novel therapeutic exercise intervention for clinicians and health policymakers.

Conditions

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Sarcopenia Muscle Weakness Walking, Difficulty Balance Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental group 1

A novel-designed intrinsic foot muscle-strengthening exerciser using 3D printing techniques will be used in the experimental group.

Group Type EXPERIMENTAL

integrated exercise therapy with 3D printing exerciser for training intrinsic foot muscles

Intervention Type BEHAVIORAL

The therapeutic exercise program with a custom-made 3-D printing foot core exerciser, consisting of warm-up exercise, active range of motion in the foot and ankle joints, foot core system strengthening program using the 3D printing device, and stretching exercises for foot and ankle.

Experimental group 2

A regular exercise program will be provided in this group.

Group Type SHAM_COMPARATOR

regular exercises for the elderly

Intervention Type BEHAVIORAL

The regular exercise provided for the elderly in the dwelling community, including walking, simple aerobic exercises, stretching exercises

Control group

There is no exercise or other intervention in this group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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integrated exercise therapy with 3D printing exerciser for training intrinsic foot muscles

The therapeutic exercise program with a custom-made 3-D printing foot core exerciser, consisting of warm-up exercise, active range of motion in the foot and ankle joints, foot core system strengthening program using the 3D printing device, and stretching exercises for foot and ankle.

Intervention Type BEHAVIORAL

regular exercises for the elderly

The regular exercise provided for the elderly in the dwelling community, including walking, simple aerobic exercises, stretching exercises

Intervention Type BEHAVIORAL

Other Intervention Names

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novel foot core exercise program regular exercises

Eligibility Criteria

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Inclusion Criteria

* the elderly with sarcopenia \[1, 2\] Age is more than 65 years with a medical diagnosis of sarcopenia Be able to independently stand and walk To meet the criteria of the definition of sarcopenia in the AWGS 2019 consensus update on sarcopenia diagnosis and treatment Be able to understand independently the participation consent in this research project
* Healthy elder individuals A neutral foot alignment: determined by measurement of the resting calcaneal stance position (RCSP: between 2˚of inversion and 2˚of eversion) and scores on the navicular drop (ND: between 5 and 9 mm) test.

Foot Posture Index (FPI) Score is between 0 and 5. No pain in the lower limbs No history of lower limb injury that has affected function or caused the individual to seek previous medical or therapeutic intervention within 6 months

Exclusion Criteria

* All groups not be able to sign the consent form for the participation Traumatic injury to lower limbs which impacted joint integrity and function (i.e., fractures) resulting in at least 1 interrupted day of desired physical activity Major neurological, cardiorespiratory, or circulatory disorders contribute to not being able to independently stand and walk.

Recent intervention/management within the last 6 months
Minimum Eligible Age

65 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chich-Haung R Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

College of Medicine, Tzu Chi University

Locations

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BuddhistTCGH

Hualien City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chich-Haung R Yang, PhD

Role: CONTACT

+886-3-856-5301 ext. 2496

Ya-Huei Su, BSc

Role: CONTACT

+886-3-856-1825 ext. 12124

Facility Contacts

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Chich-Haung Yang, PhD

Role: primary

+886-3-8565301 ext. 2496

References

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Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

Reference Type BACKGROUND
PMID: 32033882 (View on PubMed)

Dufour AB, Hannan MT, Murabito JM, Kiel DP, McLean RR. Sarcopenia definitions considering body size and fat mass are associated with mobility limitations: the Framingham Study. J Gerontol A Biol Sci Med Sci. 2013 Feb;68(2):168-74. doi: 10.1093/gerona/gls109. Epub 2012 Apr 13.

Reference Type BACKGROUND
PMID: 22503991 (View on PubMed)

Kao SL, Hsiao ML, Wang JH, Chen CS, Chen SY, Shiau YJ, Yang CH. Effects of integrated intrinsic foot muscle exercise with foot core training device on balance and body composition among community-dwelling adults aged 60 and above. BMC Geriatr. 2024 May 7;24(1):403. doi: 10.1186/s12877-024-04945-y.

Reference Type DERIVED
PMID: 38714957 (View on PubMed)

Other Identifiers

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P00001837

Identifier Type: -

Identifier Source: org_study_id

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