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

Primary Purpose

Sarcopenia, Muscle Weakness, Walking, Difficulty

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
integrated exercise therapy with 3D printing exerciser for training intrinsic foot muscles
regular exercises for the elderly
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sarcopenia focused on measuring Foot core system, Intrinsic foot muscle, Balance control, 3D printing, Gait

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • BuddhistTCGHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Experimental group 1

Experimental group 2

Control group

Arm Description

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

A regular exercise program will be provided in this group.

There is no exercise or other intervention in this group.

Outcomes

Primary Outcome Measures

Sonographic imaging for cross-sectional area of muscles
The diagnostic ultrasound will be employed to detect the cross-sectional area (CSA) in specific foot intrinsic and extrinsic muscles, such as extrinsic muscle (Flexor digitorum longus FDL, Flexor Hallucis Longus FHL, and Peroneal longus PL) and intrinsic muscle ( Abductor Hallucis AbdH, Flexor Digitorum Brevis FDB and Flexor Hallucis Brevis FHB) CSA. The unit is cm2
Sonographic imaging for the width and thickness of muscles
The diagnostic ultrasound will be employed to detect the width and thickness of specific foot intrinsic and extrinsic muscles, such as extrinsic muscles (FDL, FHL, and PER) and intrinsic muscle (AbdH, FDB, and FHB)width and thickness, and plantar fascia thickness (at the heel, mid and forefoot sites). The unit is cm (the width and length)
Balance test for standing posture for area of sway trajectory in center of pressure (CoP) and center of mass (CoM)
A complete lower limb model will be established through commercial motion analysis software. Motion Analysis System with 12 optoelectronic cameras and two high-speed video cameras with two force plates will be used for further analysis in standing and level walking. Static postural control will be assessed in a quiet standing task on the two force plates to measure the variables of the center of pressure (CoP) and center of mass (CoM) at eyes-open and eyes-closed conditions. The unit is mm.
Balance test for standing posture for the velocity of sway trajectory in center of pressure (CoP) and center of mass (CoM)
A complete lower limb model will be established through commercial motion analysis software. Motion Analysis System with 12 optoelectronic cameras and two high-speed video cameras with two force plates will be used for further analysis in standing and level walking. Static postural control will be assessed in a quiet standing task on the two force plates to measure the variables of the center of pressure (CoP) and center of mass (CoM) at eyes-open and eyes-closed conditions. The unit is mm/sec.
Balance test for standing posture for the length of sway trajectory in center of pressure (CoP)
A complete lower limb model will be established through commercial motion analysis software. Motion Analysis System with 12 optoelectronic cameras and two high-speed video cameras with two force plates will be used for further analysis in standing and level walking. Static postural control will be assessed in a quiet standing task on the two force plates to measure the variables of the center of pressure (CoP) and center of mass (CoM) at eyes-open and eyes-closed conditions. The unit is mm.
Functional walking test for spatio-temporal parameters
Spatio-temporal parameters will be calculated during level walking. The subject will be asked to walk at slow, self-paced, and fast walking using a metronome. The unit is m/sec.
Functional walking test for joint kinematics in the lower limb
Joint kinematic data will be calculated during level walking. The subject will be asked to walk at slow, self-paced, and fast walking using a metronome. The unit is degree.
Functional walking test for joint kinetics in the lower limb
Joint kinetic data will be calculated during level walking. The subject will be asked to walk at slow, self-paced, and fast walking using a metronome. The unit is Nm.
Clinical Questionnaires for assessment in physical capacity in the elderly
Short Physical Performance Battery (0-12) questionnaires will be employed in this study. The unit is a unit on a scale.
Clinical Questionnaires for assessment in functional capacity and falling condition in the elderly
Strength, Assisting with walking, Rising from a chair, Climbing stairs, and Falling questionnaire (0-10) will be employed in this study. The unit is a unit on a scale.
Clinical Questionnaires for assessment in functional capacity and strength condition in the elderly
Strength, Assisting with walking, Rising from a chair, Climbing stairs, and Calf circumference (0-20). The unit is a unit on a scale.

Secondary Outcome Measures

Clinical Questionnaires for assessment in cognitive capacity in the elderly
Mini-Mental State Examination (0-30) questionnaires will be employed in this study. The unit is a unit on a scale.
Clinical Questionnaires for assessment in nutritional status in the elderly
Mini Nutritional Assessment - Short Form (0-11) will be employed in this study. The unit is a unit on a scale.
Clinical Questionnaires for assessment in frail status in the elderly
Frail Index (0.0-1.0) will be employed in this study. The unit is a unit on a scale.
Clinical Questionnaires for assessment in frailty condition the elderly
A clinical Frailty Scale (1-9) will be employed in this study. The unit is a unit on a scale.

Full Information

First Posted
November 21, 2022
Last Updated
February 20, 2023
Sponsor
Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05750888
Brief Title
Foot Core Exercise Program on Balance Control and Walking in Aged Sarcopenia
Official Title
Effects of Integrated Foot Core Strengthening With Exerciser Device on Balance Control and Walking in the Elderly With and Without Sarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buddhist Tzu Chi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Muscle Weakness, Walking, Difficulty, Balance Control
Keywords
Foot core system, Intrinsic foot muscle, Balance control, 3D printing, Gait

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group 1
Arm Type
Experimental
Arm Description
A novel-designed intrinsic foot muscle-strengthening exerciser using 3D printing techniques will be used in the experimental group.
Arm Title
Experimental group 2
Arm Type
Sham Comparator
Arm Description
A regular exercise program will be provided in this group.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
There is no exercise or other intervention in this group.
Intervention Type
Behavioral
Intervention Name(s)
integrated exercise therapy with 3D printing exerciser for training intrinsic foot muscles
Other Intervention Name(s)
novel foot core exercise program
Intervention Description
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
Intervention Name(s)
regular exercises for the elderly
Other Intervention Name(s)
regular exercises
Intervention Description
The regular exercise provided for the elderly in the dwelling community, including walking, simple aerobic exercises, stretching exercises
Primary Outcome Measure Information:
Title
Sonographic imaging for cross-sectional area of muscles
Description
The diagnostic ultrasound will be employed to detect the cross-sectional area (CSA) in specific foot intrinsic and extrinsic muscles, such as extrinsic muscle (Flexor digitorum longus FDL, Flexor Hallucis Longus FHL, and Peroneal longus PL) and intrinsic muscle ( Abductor Hallucis AbdH, Flexor Digitorum Brevis FDB and Flexor Hallucis Brevis FHB) CSA. The unit is cm2
Time Frame
changes among baseline, 4, 8 and 12 weeks
Title
Sonographic imaging for the width and thickness of muscles
Description
The diagnostic ultrasound will be employed to detect the width and thickness of specific foot intrinsic and extrinsic muscles, such as extrinsic muscles (FDL, FHL, and PER) and intrinsic muscle (AbdH, FDB, and FHB)width and thickness, and plantar fascia thickness (at the heel, mid and forefoot sites). The unit is cm (the width and length)
Time Frame
changes among baseline, 4, 8 and 12 weeks
Title
Balance test for standing posture for area of sway trajectory in center of pressure (CoP) and center of mass (CoM)
Description
A complete lower limb model will be established through commercial motion analysis software. Motion Analysis System with 12 optoelectronic cameras and two high-speed video cameras with two force plates will be used for further analysis in standing and level walking. Static postural control will be assessed in a quiet standing task on the two force plates to measure the variables of the center of pressure (CoP) and center of mass (CoM) at eyes-open and eyes-closed conditions. The unit is mm.
Time Frame
changes among baseline, 4, 8 and 12 weeks
Title
Balance test for standing posture for the velocity of sway trajectory in center of pressure (CoP) and center of mass (CoM)
Description
A complete lower limb model will be established through commercial motion analysis software. Motion Analysis System with 12 optoelectronic cameras and two high-speed video cameras with two force plates will be used for further analysis in standing and level walking. Static postural control will be assessed in a quiet standing task on the two force plates to measure the variables of the center of pressure (CoP) and center of mass (CoM) at eyes-open and eyes-closed conditions. The unit is mm/sec.
Time Frame
changes among baseline, 4, 8 and 12 weeks
Title
Balance test for standing posture for the length of sway trajectory in center of pressure (CoP)
Description
A complete lower limb model will be established through commercial motion analysis software. Motion Analysis System with 12 optoelectronic cameras and two high-speed video cameras with two force plates will be used for further analysis in standing and level walking. Static postural control will be assessed in a quiet standing task on the two force plates to measure the variables of the center of pressure (CoP) and center of mass (CoM) at eyes-open and eyes-closed conditions. The unit is mm.
Time Frame
changes among baseline, 4, 8 and 12 weeks
Title
Functional walking test for spatio-temporal parameters
Description
Spatio-temporal parameters will be calculated during level walking. The subject will be asked to walk at slow, self-paced, and fast walking using a metronome. The unit is m/sec.
Time Frame
changes among baseline, 4, 8 and 12 weeks
Title
Functional walking test for joint kinematics in the lower limb
Description
Joint kinematic data will be calculated during level walking. The subject will be asked to walk at slow, self-paced, and fast walking using a metronome. The unit is degree.
Time Frame
changes among baseline, 4, 8 and 12 weeks
Title
Functional walking test for joint kinetics in the lower limb
Description
Joint kinetic data will be calculated during level walking. The subject will be asked to walk at slow, self-paced, and fast walking using a metronome. The unit is Nm.
Time Frame
changes among baseline, 4, 8 and 12 weeks
Title
Clinical Questionnaires for assessment in physical capacity in the elderly
Description
Short Physical Performance Battery (0-12) questionnaires will be employed in this study. The unit is a unit on a scale.
Time Frame
changes among baseline, 4, 8 and 12 weeks
Title
Clinical Questionnaires for assessment in functional capacity and falling condition in the elderly
Description
Strength, Assisting with walking, Rising from a chair, Climbing stairs, and Falling questionnaire (0-10) will be employed in this study. The unit is a unit on a scale.
Time Frame
changes among baseline, 4, 8 and 12 weeks
Title
Clinical Questionnaires for assessment in functional capacity and strength condition in the elderly
Description
Strength, Assisting with walking, Rising from a chair, Climbing stairs, and Calf circumference (0-20). The unit is a unit on a scale.
Time Frame
changes among baseline, 4, 8 and 12 weeks
Secondary Outcome Measure Information:
Title
Clinical Questionnaires for assessment in cognitive capacity in the elderly
Description
Mini-Mental State Examination (0-30) questionnaires will be employed in this study. The unit is a unit on a scale.
Time Frame
changes among baseline, 4, 8 and 12 weeks
Title
Clinical Questionnaires for assessment in nutritional status in the elderly
Description
Mini Nutritional Assessment - Short Form (0-11) will be employed in this study. The unit is a unit on a scale.
Time Frame
changes among baseline, 4, 8 and 12 weeks
Title
Clinical Questionnaires for assessment in frail status in the elderly
Description
Frail Index (0.0-1.0) will be employed in this study. The unit is a unit on a scale.
Time Frame
changes among baseline, 4, 8 and 12 weeks
Title
Clinical Questionnaires for assessment in frailty condition the elderly
Description
A clinical Frailty Scale (1-9) will be employed in this study. The unit is a unit on a scale.
Time Frame
changes among baseline, 4, 8 and 12 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
The studies will involve individuals between 65-95 years of age with planned male to female ratio of 1:1
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chich-Haung R Yang, PhD
Phone
+886-3-856-5301
Ext
2496
Email
r.chyang@gms.tcu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Ya-Huei Su, BSc
Phone
+886-3-856-1825
Ext
12124
Email
irb@tzuchi.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chich-Haung R Yang, PhD
Organizational Affiliation
College of Medicine, Tzu Chi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
BuddhistTCGH
City
Hualien City
ZIP/Postal Code
97004
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chich-Haung Yang, PhD
Phone
+886-3-8565301
Ext
2496
Email
r.chyang@gms.tcu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32033882
Citation
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.
Results Reference
background
PubMed Identifier
22503991
Citation
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.
Results Reference
background

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

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