Effects of Improved Calf Muscle Function on Gait, Balance and Joint Loading in Older Adults

Improving Plantarflexor Muscle Function to Alleviate Decline in Mobility, Loss of Balance and Detrimental Knee Joint Loading in Older Adults

This study investigates the role of calf muscle function in gait performance, balance and knee joint loading.

Previous studies have linked age-related loss of calf muscle function with impairments in gait performance and balance, and increased loading of the areas of the knee joint that are susceptible to the development of osteoarthritis. In this study, an exercise intervention targeting structural and neural aspects of impaired calf muscle function with ageing is utilized. The intervention lasts 8 weeks and includes either biofeedback training using electromyography to alter muscle activation patterns or a combination of biofeedback training and strength training for the calf muscle to modify calf function during walking. The study will test whether the intervention improves walking speed, reduces the metabolic cost of walking, improves standing balance and reduces knee joint loading.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee; Mobility Limitation; Accidental Fall
• Intervention / Treatment: Other: Gait retraining; Other: Gait retraining + strength training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauri Stenroth, PhD; Phone Number: +358505649096; Email: lauri.stenroth@uef.fi

Study Locations

• Finland
  • North Savo
    • Kuopio, North Savo, Finland, 70100
      • University of Eastern Finland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• age between 65 and 75

Exclusion Criteria:

• dependent living status
• not able to walk without an assistive device or for 30 min without stopping
• diagnosed neurological disease or joint disorder and pain during walking
• surgery on lower extremities
• current musculoskeletal injury
• previous cardiovascular event or symptoms during exercise (acute ECG change, coronary disease, symptomatic arrhythmia, symptomatic coronary stenosis, heart failure, myocarditis, pericarditis, pulmonary embolism, pulmonary infarct, artery bulge or rupture risk)
• body mass index <18 or >35 kg/m2
• contraindications for magnetic resonance imaging
• Mini Mental State Examination score of 23 points and lower

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gait retraining; 8-week intervention. Intervention includes weekly gait retraining sessions with real-time electromyography biofeedback.	Other: Gait retraining; Gait retraining using real-time electromyography biofeedback performed once per week for eight weeks. During the gait retraining session the participant is walking on a treadmill while receiving information on calf muscle activation. A single session includes five bouts of walking each lasting for 5 minutes. During the first bout, the participant is receiving feedback (visual and auditive) on soleus muscle activation with the aim to increase it by 20% from their normal walking. During the second bout, the participant is receiving feedback (visual and auditive) on medial gastrocnemius muscle activation with the aim to decrease it by 20% from their normal walking. During the last three bouts, the participant is receiving feedback (visual and auditive) on the soleus to medial gastrocnemius muscle activation ratio with the aim to increase it by 20% from their normal walking. If hitting the target, the aim is increased by 5% for the subsequent bout.
Experimental: Gait retraining + strength training; 8-week intervention. Intervention includes weekly gait retraining sessions with real-time electromyography biofeedback and home-based strength training session for plantarflexor muscles three times per week.	Other: Gait retraining + strength training; Gait retraining using real-time electromyography biofeedback performed once per week and home-based calf muscle strength training performed three times per week for eight weeks. The gait retraining is identical to the one intervention described for the intervention group "Gait retraining". The strength training is performed three times per week except for the first week in which it is performed two times. The session contained a warm-up (3x10 repetitions of two-legged heel raises) and maximal isometric calf muscle contractions. The maximal contractions are performed using a custom device with the ankle in dorsiflexion and the knee flexed by 100-120 degrees. Three sets of 10 repetitions (3-second contraction and 3-second rest) are performed with both legs and with maximal effort and 1-minute rest between the sets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in knee joint loading	Change in tibiofemoral compressive loading during walking estimated using musculoskeletal modeling and simulation. Loading is calculated separately for medial and lateral compartments of the tibiofemoral joint.	within 1 weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in energy cost of walking	Assessed using indirect calorimetry.	within 1 weeks after intervention
Change from baseline in standing balance	Sway during standing measured using a force plate with eyes open and closed	within 1 weeks after intervention
Change from baseline in Achilles tendon stiffness	Achilles tendon stiffness evaluated using combination of ultrasonography, motion analysis and force measurements.	within 1 weeks after intervention
Change from baseline in gait kinematics	Time series of lower limb joint angles during walking stride assessed using motion capture system and inverse kinematics.	within 1 weeks after intervention
Change from baseline in joint moments during walking	Time series of lower limb joint moments during walking stride assessed using inverse dynamics based on motion capture system and instrumented treadmill data.	within 1 weeks after intervention
Change from baseline in joint powers during walking	Time series of lower limb joint powers during walking stride assessed using inverse dynamics based on motion capture system and instrumented treadmill data.	within 1 weeks after intervention
Change from baseline in distribution of joint work during walking	Distribution of total positive lower limb work between the joints during walking assessed using inverse dynamics based on motion capture system and instrumented treadmill data.	within 1 weeks after intervention
Change from baseline in muscle-tendon function during walking	Muscle fascicle kinematics measured using dynamics ultrasonography during walking.	within 1 weeks after intervention
Change from baseline in soleus to gastrocnemius muscle activation ratio	Relative activation of soleus to medial gastrocnemius measured using electromyography.	within 1 weeks after intervention
Change from baseline in walking speed	Preferred and maximal walking speed.	within 1 weeks after intervention
Change from baseline in muscle strength	Maximal isometric muscle strength in ankle plantarflexion and knee extension and flexion.	within 1 weeks after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in triceps surae fascicle lengths	Soleus and gastrocnemius muscle fascicle length assessed using ultrasound imaging.	within 1 weeks after intervention
Change from baseline in triceps surae fascicle pennation angle	Soleus and gastrocnemius muscle pennation angle assessed using ultrasound imaging.	within 1 weeks after intervention
Change from baseline in triceps surae muscle volume	Soleus and gastrocnemius muscle volume estimated with combination of ultrasound and magnetic resonance imaging.	within 1 weeks after intervention
Change from baseline in Achilles tendon cross-sectional area	Achilles tendon cross-sectional area assessed using magnetic resonance imaging.	within 1 weeks after intervention
Change from baseline in dynamics balance control	Perturbed standing balance test with measurement of center of pressure trajectory	within 1 weeks after intervention
Change from baseline in triceps surae muscle activity in response to balance perturbation	Perturbed standing balance test with measurement of triceps surae muscle activities.	within 1 weeks after intervention

Collaborators and Investigators

• Sponsor: University of Eastern Finland
• Investigators: Principal Investigator: Lauri Stenroth, PhD, University of Eastern Finland

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Balance; Osteoarthritis; Gait; Knee; Electromyography; Walking; Biofeedback; Strength training; Achilles tendon; Triceps surae
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Mobility Limitation
• Other Study ID Numbers: LS_Plantarflex

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained during the study will be shared with other researcher after the results have been published. Details of the data will be updated later.
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: At request from the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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