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

Sponsor

University of Eastern Finland (Other)

Overall Status

Suspended

CT.gov ID

NCT03921801

Collaborator

(none)

Enrollment

Location

Arms

59.3

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study investigates role of calf muscle function for 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 knee joint that are susceptible for development of osteoarthritis. In this study, an exercise intervention is used to target structural and neural aspects of impaired calf muscle function with aging. The intervention includes 14 weeks of strength training for the calf muscles and training sessions to enhance calf function during walking. The study will test whether the intervention is effective in improving walking speed, reduce metabolic cost of walking, improve standing balance and reduce knee joint loading.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee Mobility Limitation Accidental Fall	Behavioral: Strength training + biofeedback	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 for 14 weeks while the other group serves as a control group without receiving any intervention. At the end, outcome measures are obtained. A third group consists of 15 young adults. This group does not receive intervention and outcome measures are obtained only at a single time point.Thirty older adults will be recruited and randomized into two groups. The other groups receive an intervention including strength training and gait retraining lasting for 14 weeks while the other group serves as a control group without receiving any intervention. At the end, outcome measures are obtained. A third group consists of 15 young adults. This group does not receive intervention and outcome measures are obtained only at a single time point.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Dec 21, 2018

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control 14-week control period.
Experimental: Intervention 14-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.	Behavioral: Strength training + biofeedback Home based strength training intervention for plantarflexor muscles conducted three times per week for 14 weeks. In addition, gait retraining session using real-time electromyography biofeedback performed once per week.
No Intervention: Young adults - control Outcome measures obtained at a single time point. The data is used to compare outcome measured between older and young adults.

Arm

Intervention/Treatment

No Intervention: Control

14-week control period.

Experimental: Intervention

14-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.

Behavioral: Strength training + biofeedback

Home based strength training intervention for plantarflexor muscles conducted three times per week for 14 weeks. In addition, gait retraining session using real-time electromyography biofeedback performed once per week.

No Intervention: Young adults - control

Outcome measures obtained at a single time point. The data is used to compare outcome measured between older and young adults.

Outcome Measures

Primary Outcome Measures

Knee joint loading at baseline [At week 0]
Knee joint loading during walking assessed at baseline. Estimated using musculoskeletal modeling and simulation.
Knee joint loading at week 14 [At week 14]
Knee joint loading during walking assessed at week 14. Estimated using musculoskeletal modeling and simulation.
Maximal walking speed at baseline [At week 0]
Maximal walking speed at baseline. Assessed using 10-meter walking trial.
Maximal walking speed at week 14 [At week 14]
Maximal walking speed at week 14. Assessed using 10-meter walking trial.
Preferred walking speed at baseline [At week 0]
Baseline preferred walking speed. Assessed using 10-meter walking trial
Preferred walking speed at week 14 [At week 14]
Preferred walking speed at week 14. Assessed using 10-meter walking trial
Baseline walking economy [At week 0]
Baseline metabolic energy cost required to travel unit distance. Measured during walking using indirect calorimetry.
Walking economy at week 14 [At week 14]
Metabolic energy cost required to travel unit distance at week 14. Measured during walking using indirect calorimetry.
Baseline standing balance [At week 0]
Baseline standing balance. Measured as center of pressure sway during eyes open and closed standing on a force plate.
Standing balance at week 14 [At week 14]
Standing balance at week 14. Measured as center of pressure sway during eyes open and closed standing on a force plate.

Secondary Outcome Measures

Muscle strength [Up to week 14]
Ankle plantarflexor muscle strength assessed using maximal isometric contractions.
Triceps surae muscle morphology [At weeks 0 and 14]
Triceps surae muscle cross-sectional area, volume and muscle architecture (fascicle length and pennation angle) measured using magnetic resonance imaging and ultrasound imaging.
Achilles tendon stiffness [At weeks 0 and 14]
Achilles tendon stiffness evaluated using combination of ultrasonography, motion analysis and force measurements.
Walking mechanics [At weeks 0 and 14]
Kinematic, kinetic and electromyographic description of walking mechanics measured using instrumented treadmill, motion capture system and electromyography measurements.
Muscle-tendon function during walking [At weeks 0 and 14]
Muscle fascicle kinematics measured using dynamics ultrasonography during walking.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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