Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03921801
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Lauri Stenroth, University of Eastern Finland

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Thirty older adult will be recruited and randomized to 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. After the intervention, outcome measures will be obtained. After this, the groups are crossed over and the first group will be control group for 14 weeks and the second group will receive the same intervention as the first group during the initial 14 weeks. At the end, outcome measured are obtained.

A third group consists of 15 young adults. This group does not receive intervention and outcome measure are obtained only at 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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control-intervention
14 week control period followed by 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.

Experimental: Intervention-control
14 week intervention followed by 14 week period. 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 single time point. The data is used to compare outcome measured between older and young adults.



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. Knee joint loading at week 28 [ Time Frame: At week 28 ]
    Knee joint loading during walking assessed at week 28. Estimated using musculoskeletal modeling and simulation.

  4. Maximal walking speed at baseline [ Time Frame: At week 0 ]
    Maximal walking speed at baseline. Assessed using 10-meter walking trial.

  5. Maximal walking speed at week 14 [ Time Frame: At week 14 ]
    Maximal walking speed at week 14. Assessed using 10-meter walking trial.

  6. Maximal walking speed at week 28 [ Time Frame: At week 28 ]
    Maximal walking speed at week 28. Assessed using 10-meter walking trial.

  7. Preferred walking speed at baseline [ Time Frame: At week 0 ]
    Baseline preferred walking speed. Assessed using 10-meter walking trial

  8. Preferred walking speed at week 14 [ Time Frame: At week 14 ]
    Preferred walking speed at week 14. Assessed using 10-meter walking trial

  9. Preferred walking speed at week 28 [ Time Frame: At week 28 ]
    Preferred walking speed at week 28. Assessed using 10-meter walking trial

  10. Baseline walking economy [ Time Frame: At week 0 ]
    Baseline metabolic energy cost required to travel unit distance. Measured during walking using indirect calorimetry.

  11. 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.

  12. Walking economy at week 28 [ Time Frame: At week 28 ]
    Metabolic energy cost required to travel unit distance at week 28. Measured during walking using indirect calorimetry.

  13. 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.

  14. 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.

  15. Standing balance at week 28 [ Time Frame: At week 28 ]
    Standing balance at week 28. 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 28 ]
    Ankle plantarflexor muscle strength assessed using maximal isometric contractions.

  2. Triceps surae muscle morphology [ Time Frame: At weeks 0, 14 and 28 ]
    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, 14 and 28 ]
    Achilles tendon stiffness evaluated using combination of ultrasonography, motion analysis and force measurements.

  4. Walking mechanics [ Time Frame: At weeks 0, 14 and 28 ]
    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, 14 and 28 ]
    Muscle fascicle kinematics measured using dynamics ultrasonography during walking.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921801


Contacts
Layout table for location contacts
Contact: Lauri Stenroth, PhD +358505649096 lauri.stenroth@uef.fi

Locations
Layout table for location information
Finland
University of Eastern Finland Recruiting
Kuopio, North Savo, Finland, 70100
Contact: Lauri Stenroth, PhD         
Sponsors and Collaborators
University of Eastern Finland
Investigators
Layout table for investigator information
Principal Investigator: Lauri Stenroth, PhD University of Eastern Finland

Layout table for additonal information
Responsible Party: Lauri Stenroth, Postdoctoral researcher, University of Eastern Finland
ClinicalTrials.gov Identifier: NCT03921801     History of Changes
Other Study ID Numbers: LS_Plantarflex
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
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.

Layout table for additional information
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:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Mobility Limitation
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Signs and Symptoms