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

NCT ID: NCT03921801

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-13

Study Completion Date

2024-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee Mobility Limitation Accidental Fall

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Gait retraining

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

Group Type ACTIVE_COMPARATOR

Gait retraining

Intervention Type 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 + strength training

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.

Group Type EXPERIMENTAL

Gait retraining + strength training

Intervention Type 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.

Interventions

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Gait retraining

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

Gait retraining + strength training

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Eastern Finland

OTHER

Sponsor Role lead

Responsible Party

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Lauri Stenroth

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lauri Stenroth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Locations

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University of Eastern Finland

Kuopio, Northern Savonia, Finland

Site Status

Countries

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Finland

Other Identifiers

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LS_Plantarflex

Identifier Type: -

Identifier Source: org_study_id

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