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

NCT03921801 | Completed

• 1 other identifier: LS_Plantarflex
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Mobility Limitation; Accidental Fall

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  within 1 weeks after intervention

Secondary Outcomes (11)

• Change from baseline in energy cost of walking

  within 1 weeks after intervention

• Change from baseline in standing balance

  within 1 weeks after intervention

• Change from baseline in Achilles tendon stiffness

  within 1 weeks after intervention

• Change from baseline in gait kinematics

  within 1 weeks after intervention

• Change from baseline in joint moments during walking

  within 1 weeks after intervention

Other Outcomes (6)

• Change from baseline in triceps surae fascicle lengths

  within 1 weeks after intervention

• Change from baseline in triceps surae fascicle pennation angle

  within 1 weeks after intervention

• Change from baseline in triceps surae muscle volume

  within 1 weeks after intervention

Study Arms (2)

Gait retraining

ACTIVE COMPARATOR

8-week intervention. Intervention includes weekly gait retraining sessions with real-time electromyography biofeedback.

Other: Gait retraining

Gait retraining + strength training

EXPERIMENTAL

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.

Other: Gait retraining + strength training

Interventions

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

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.

Gait retraining + strength training

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• age between 65 and 75

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Eastern Finland: lead

Study Sites (1)

University of Eastern Finland

Kuopio, Northern Savonia, 70100, Finland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Mobility Limitation; Osteoarthritis

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lauri Stenroth, PhD

  University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: April 19, 2019
• Study Start: April 13, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication
• Access Criteria: At request from the principal investigator.

Locations

FI (1)