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

NCT05750888 | Unknown DMC

• 1 other identifier: P00001837
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Muscle Weakness; Walking, Difficulty; Balance Control

Keywords

Foot core system; Intrinsic foot muscle; Balance control; 3D printing; Gait

Outcome Measures

Primary Outcomes (11)

• 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

  changes among baseline, 4, 8 and 12 weeks

• 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)

  changes among baseline, 4, 8 and 12 weeks

• 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.

  changes among baseline, 4, 8 and 12 weeks

• 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.

  changes among baseline, 4, 8 and 12 weeks

• 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.

  changes among baseline, 4, 8 and 12 weeks

• 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.

  changes among baseline, 4, 8 and 12 weeks

• 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.

  changes among baseline, 4, 8 and 12 weeks

• 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.

  changes among baseline, 4, 8 and 12 weeks

• 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.

  changes among baseline, 4, 8 and 12 weeks

• 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.

  changes among baseline, 4, 8 and 12 weeks

• 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.

  changes among baseline, 4, 8 and 12 weeks

Secondary Outcomes (4)

• Clinical Questionnaires for assessment in cognitive capacity in the elderly

  changes among baseline, 4, 8 and 12 weeks

• Clinical Questionnaires for assessment in nutritional status in the elderly

  changes among baseline, 4, 8 and 12 weeks

• Clinical Questionnaires for assessment in frail status in the elderly

  changes among baseline, 4, 8 and 12 weeks

• Clinical Questionnaires for assessment in frailty condition the elderly

  changes among baseline, 4, 8 and 12 weeks

Study Arms (3)

Experimental group 1

EXPERIMENTAL

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

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

Experimental group 2

SHAM COMPARATOR

A regular exercise program will be provided in this group.

Behavioral: regular exercises for the elderly

Control group

NO INTERVENTION

There is no exercise or other intervention in this group.

Interventions

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

Also known as: novel foot core exercise program

Experimental group 1

regular exercises for the elderly BEHAVIORAL

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

Also known as: regular exercises

Experimental group 2

Eligibility Criteria

• Age: 65 Years - 95 Years
• Gender Eligibility Details: The studies will involve individuals between 65-95 years of age with planned male to female ratio of 1:1
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

BuddhistTCGH

Hualien City, 97004, Taiwan

RECRUITING

Related Publications (3)

• 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.

  PMID: 32033882 BACKGROUND

• 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.

  PMID: 22503991 BACKGROUND

• 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.

  PMID: 38714957 DERIVED

MeSH Terms

Conditions

Sarcopenia; Muscle Weakness; Mobility Limitation

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes

Study Officials

• Chich-Haung R Yang, PhD

  College of Medicine, Tzu Chi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chich-Haung R Yang, PhD

CONTACT

+886-3-856-5301; r.chyang@gms.tcu.edu.tw

Ya-Huei Su, BSc

CONTACT

+886-3-856-1825; irb@tzuchi.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: March 2, 2023
• Study Start: August 30, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: March 2, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)