Clinical trial NCT03921801: Effects of Improved Calf Muscle Function on Gait, Balance and Joint Loading in Older Adults
Official title: Improving Plantarflexor Muscle Function to Alleviate Decline in Mobility, Loss of Balance and Detrimental Knee Joint Loading in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Mobility Limitation
Accidental Fall
Keywords: Osteoarthritis
Knee
Achilles tendon
Triceps surae
Balance
Electromyography
Biofeedback
Strength training
Gait
Walking
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Thirty older adults will be recruited and randomized into two groups. The other groups receive an intervention including strength training and gait retraining lasting 8 weeks while the other group receives only the gait retraining. Outcome measures are obtained before and after the intervention period.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in knee joint loading
timeFrame: within 1 weeks after intervention
Secondary outcomes:
measure: Change from baseline in energy cost of walking
timeFrame: within 1 weeks after intervention
measure: Change from baseline in standing balance
timeFrame: within 1 weeks after intervention
measure: Change from baseline in Achilles tendon stiffness
timeFrame: within 1 weeks after intervention
measure: Change from baseline in gait kinematics
timeFrame: within 1 weeks after intervention
measure: Change from baseline in joint moments during walking
timeFrame: within 1 weeks after intervention
measure: Change from baseline in joint powers during walking
timeFrame: within 1 weeks after intervention
measure: Change from baseline in distribution of joint work during walking
timeFrame: within 1 weeks after intervention
measure: Change from baseline in muscle-tendon function during walking
timeFrame: within 1 weeks after intervention
measure: Change from baseline in soleus to gastrocnemius muscle activation ratio
timeFrame: within 1 weeks after intervention
measure: Change from baseline in walking speed
timeFrame: within 1 weeks after intervention
measure: Change from baseline in muscle strength
timeFrame: within 1 weeks after intervention
Other outcomes:
measure: Change from baseline in triceps surae fascicle lengths
timeFrame: within 1 weeks after intervention
measure: Change from baseline in triceps surae fascicle pennation angle
timeFrame: within 1 weeks after intervention
measure: Change from baseline in triceps surae muscle volume
timeFrame: within 1 weeks after intervention
measure: Change from baseline in Achilles tendon cross-sectional area
timeFrame: within 1 weeks after intervention
measure: Change from baseline in dynamics balance control
timeFrame: within 1 weeks after intervention
measure: Change from baseline in triceps surae muscle activity in response to balance perturbation
timeFrame: within 1 weeks after intervention
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland
state: North Savo
Study officials:
affiliation: University of Eastern Finland
name: Lauri Stenroth, PhD
role: PRINCIPAL_INVESTIGATOR
References: