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

• ClinicalTrials.gov Identifier: NCT03921801
• Recruitment Status: Recruiting
• First Posted: April 19, 2019
• Last Update Posted: March 12, 2020
• Sponsor: University of Eastern Finland
• Information provided by (Responsible Party): Lauri Stenroth, University of Eastern Finland

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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.

• 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: December 21, 2018
• Estimated Primary Completion Date: October 1, 2021
• Estimated Study Completion Date: October 1, 2021

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.

Outcome Measures

Primary Outcome Measures :

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

1. Muscle strength [ Time Frame: Up to week 14 ]
   Ankle plantarflexor muscle strength assessed using maximal isometric contractions.
2. Triceps surae muscle morphology [ Time Frame: 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.
3. Achilles tendon stiffness [ Time Frame: At weeks 0 and 14 ]
   Achilles tendon stiffness evaluated using combination of ultrasonography, motion analysis and force measurements.
4. Walking mechanics [ Time Frame: At weeks 0 and 14 ]
   Kinematic, kinetic and electromyographic description of walking mechanics measured using instrumented treadmill, motion capture system and electromyography measurements.
5. Muscle-tendon function during walking [ Time Frame: At weeks 0 and 14 ]
   Muscle fascicle kinematics measured using dynamics ultrasonography during walking.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Lauri Stenroth, PhD; +358505649096; lauri.stenroth@uef.fi

Locations

Finland

University of Eastern Finland; Recruiting

Kuopio, North Savo, Finland, 70100

Contact: Lauri Stenroth, PhD

Sponsors and Collaborators

University of Eastern Finland

Investigators

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

More Information

• Responsible Party: Lauri Stenroth, Postdoctoral researcher, University of Eastern Finland
• ClinicalTrials.gov Identifier: NCT03921801
• Other Study ID Numbers: LS_Plantarflex
• First Posted: April 19, 2019
• Last Update Posted: March 12, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Time Frame: Starting 6 months after publication
• Access Criteria: At request from the principal investigator.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lauri Stenroth, University of Eastern Finland:

Osteoarthritis; Knee; Achilles tendon; Triceps surae; Balance; Electromyography; Biofeedback; Strength training; Gait; Walking

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Mobility Limitation; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases