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Completed

NCT Number: NCT03921801

Effects of Improved Calf Muscle Function on Gait, Balance and 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.

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Key information

Conditions

Osteoarthritis, Knee Accidental Fall Arthritis Joint Diseases Mobility Limitation Musculoskeletal Diseases Osteoarthritis Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Eastern Finland

Kuopio, Northern Savonia, 70100, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gait retraining

Other

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.

Gait retraining + strength training

Other

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.

Primary outcomes

  1. Change from baseline in knee joint loading

    Time frame: within 1 weeks after intervention

    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.

Secondary outcomes

  1. Change from baseline in energy cost of walking

    Time frame: within 1 weeks after intervention

    Assessed using indirect calorimetry.

  2. Change from baseline in standing balance

    Time frame: within 1 weeks after intervention

    Sway during standing measured using a force plate with eyes open and closed

  3. Change from baseline in Achilles tendon stiffness

    Time frame: within 1 weeks after intervention

    Achilles tendon stiffness evaluated using combination of ultrasonography, motion analysis and force measurements.

  4. Change from baseline in gait kinematics

    Time frame: within 1 weeks after intervention

    Time series of lower limb joint angles during walking stride assessed using motion capture system and inverse kinematics.

  5. Change from baseline in joint moments during walking

    Time frame: within 1 weeks after intervention

    Time series of lower limb joint moments during walking stride assessed using inverse dynamics based on motion capture system and instrumented treadmill data.

  6. Change from baseline in joint powers during walking

    Time frame: within 1 weeks after intervention

    Time series of lower limb joint powers during walking stride assessed using inverse dynamics based on motion capture system and instrumented treadmill data.

  7. Change from baseline in distribution of joint work during walking

    Time frame: within 1 weeks after intervention

    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.

  8. Change from baseline in muscle-tendon function during walking

    Time frame: within 1 weeks after intervention

    Muscle fascicle kinematics measured using dynamics ultrasonography during walking.

  9. Change from baseline in soleus to gastrocnemius muscle activation ratio

    Time frame: within 1 weeks after intervention

    Relative activation of soleus to medial gastrocnemius measured using electromyography.

  10. Change from baseline in walking speed

    Time frame: within 1 weeks after intervention

    Preferred and maximal walking speed.

  11. Change from baseline in muscle strength

    Time frame: within 1 weeks after intervention

    Maximal isometric muscle strength in ankle plantarflexion and knee extension and flexion.

Other outcomes

  1. Change from baseline in triceps surae fascicle lengths

    Time frame: within 1 weeks after intervention

    Soleus and gastrocnemius muscle fascicle length assessed using ultrasound imaging.

  2. Change from baseline in triceps surae fascicle pennation angle

    Time frame: within 1 weeks after intervention

    Soleus and gastrocnemius muscle pennation angle assessed using ultrasound imaging.

  3. Change from baseline in triceps surae muscle volume

    Time frame: within 1 weeks after intervention

    Soleus and gastrocnemius muscle volume estimated with combination of ultrasound and magnetic resonance imaging.

  4. Change from baseline in Achilles tendon cross-sectional area

    Time frame: within 1 weeks after intervention

    Achilles tendon cross-sectional area assessed using magnetic resonance imaging.

  5. Change from baseline in dynamics balance control

    Time frame: within 1 weeks after intervention

    Perturbed standing balance test with measurement of center of pressure trajectory

  6. Change from baseline in triceps surae muscle activity in response to balance perturbation

    Time frame: within 1 weeks after intervention

    Perturbed standing balance test with measurement of triceps surae muscle activities.

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2019
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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