Effects of Improved Calf Muscle Function on Gait, Balance and Joint Loading in Older Adults
Primary Purpose
Osteoarthritis, Knee, Mobility Limitation, Accidental Fall
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Gait retraining
Gait retraining + strength training
Sponsored by
About this trial
This is an interventional basic science trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Achilles tendon, Triceps surae, Balance, Electromyography, Biofeedback, Strength training, Gait, Walking
Eligibility Criteria
Inclusion Criteria:
- age between 65 and 75 (older adults) or 18 and 35 (young adults)
Exclusion Criteria:
- dependent living status
- not able walk without assistive device or 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
Sites / Locations
- University of Eastern FinlandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Gait retraining
Gait retraining + strength training
Arm Description
8-week intervention. Intervention includes weekly gait retraining sessions with real-time electromyography biofeedback.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change from baseline in energy cost of walking
Assessed using indirect calorimetry.
Change from baseline in standing balance
Sway during standing measured using a force plate with eyes open and closed
Change from baseline in Achilles tendon stiffness
Achilles tendon stiffness evaluated using combination of ultrasonography, motion analysis and force measurements.
Change from baseline in gait kinematics
Time series of lower limb joint angles during walking stride assessed using motion capture system and inverse kinematics.
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.
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.
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.
Change from baseline in muscle-tendon function during walking
Muscle fascicle kinematics measured using dynamics ultrasonography during walking.
Change from baseline in soleus to gastrocnemius muscle activation ratio
Relative activation of soleus to medial gastrocnemius measured using electromyography.
Change from baseline in walking speed
Preferred and maximal walking speed.
Change from baseline in muscle strength
Maximal isometric muscle strength in ankle plantarflexion and knee extension and flexion.
Full Information
NCT ID
NCT03921801
First Posted
December 10, 2018
Last Updated
April 21, 2023
Sponsor
University of Eastern Finland
1. Study Identification
Unique Protocol Identification Number
NCT03921801
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Eastern Finland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Mobility Limitation, Accidental Fall
Keywords
Osteoarthritis, Knee, Achilles tendon, Triceps surae, Balance, Electromyography, Biofeedback, Strength training, Gait, Walking
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gait retraining
Arm Type
Active Comparator
Arm Description
8-week intervention. Intervention includes weekly gait retraining sessions with real-time electromyography biofeedback.
Arm Title
Gait retraining + strength training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Gait retraining
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Gait retraining + strength training
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline in knee joint loading
Description
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.
Time Frame
within 1 weeks after intervention
Secondary Outcome Measure Information:
Title
Change from baseline in energy cost of walking
Description
Assessed using indirect calorimetry.
Time Frame
within 1 weeks after intervention
Title
Change from baseline in standing balance
Description
Sway during standing measured using a force plate with eyes open and closed
Time Frame
within 1 weeks after intervention
Title
Change from baseline in Achilles tendon stiffness
Description
Achilles tendon stiffness evaluated using combination of ultrasonography, motion analysis and force measurements.
Time Frame
within 1 weeks after intervention
Title
Change from baseline in gait kinematics
Description
Time series of lower limb joint angles during walking stride assessed using motion capture system and inverse kinematics.
Time Frame
within 1 weeks after intervention
Title
Change from baseline in joint moments during walking
Description
Time series of lower limb joint moments during walking stride assessed using inverse dynamics based on motion capture system and instrumented treadmill data.
Time Frame
within 1 weeks after intervention
Title
Change from baseline in joint powers during walking
Description
Time series of lower limb joint powers during walking stride assessed using inverse dynamics based on motion capture system and instrumented treadmill data.
Time Frame
within 1 weeks after intervention
Title
Change from baseline in distribution of joint work during walking
Description
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.
Time Frame
within 1 weeks after intervention
Title
Change from baseline in muscle-tendon function during walking
Description
Muscle fascicle kinematics measured using dynamics ultrasonography during walking.
Time Frame
within 1 weeks after intervention
Title
Change from baseline in soleus to gastrocnemius muscle activation ratio
Description
Relative activation of soleus to medial gastrocnemius measured using electromyography.
Time Frame
within 1 weeks after intervention
Title
Change from baseline in walking speed
Description
Preferred and maximal walking speed.
Time Frame
within 1 weeks after intervention
Title
Change from baseline in muscle strength
Description
Maximal isometric muscle strength in ankle plantarflexion and knee extension and flexion.
Time Frame
within 1 weeks after intervention
Other Pre-specified Outcome Measures:
Title
Change from baseline in triceps surae fascicle lengths
Description
Soleus and gastrocnemius muscle fascicle length assessed using ultrasound imaging.
Time Frame
within 1 weeks after intervention
Title
Change from baseline in triceps surae fascicle pennation angle
Description
Soleus and gastrocnemius muscle pennation angle assessed using ultrasound imaging.
Time Frame
within 1 weeks after intervention
Title
Change from baseline in triceps surae muscle volume
Description
Soleus and gastrocnemius muscle volume estimated with combination of ultrasound and magnetic resonance imaging.
Time Frame
within 1 weeks after intervention
Title
Change from baseline in Achilles tendon cross-sectional area
Description
Achilles tendon cross-sectional area assessed using magnetic resonance imaging.
Time Frame
within 1 weeks after intervention
Title
Change from baseline in dynamics balance control
Description
Perturbed standing balance test with measurement of center of pressure trajectory
Time Frame
within 1 weeks after intervention
Title
Change from baseline in triceps surae muscle activity in response to balance perturbation
Description
Perturbed standing balance test with measurement of triceps surae muscle activities.
Time Frame
within 1 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauri Stenroth, PhD
Phone
+358505649096
Email
lauri.stenroth@uef.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauri Stenroth, PhD
Organizational Affiliation
University of Eastern Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Eastern Finland
City
Kuopio
State/Province
North Savo
ZIP/Postal Code
70100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauri Stenroth, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Effects of Improved Calf Muscle Function on Gait, Balance and Joint Loading in Older Adults
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