4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Effects of Improved Calf Muscle Function on Gait, Balance and Joint Loading in Older Adults

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

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
Layout table for study information
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 : January 2023
Estimated Study Completion Date : December 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.
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
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
Contacts and Locations

Locations
Layout table for location information
Finland
University of Eastern Finland
Kuopio, North Savo, Finland, 70100
Sponsors and Collaborators
University of Eastern Finland
Investigators
Layout table for investigator information
Principal Investigator: Lauri Stenroth, PhD University of Eastern Finland
Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date May 24, 2021
Actual Study Start Date  ICMJE December 21, 2018
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
  • Knee joint loading at baseline [ Time Frame: At week 0 ]
    Knee joint loading during walking assessed at baseline. Estimated using musculoskeletal modeling and simulation.
  • 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.
  • Maximal walking speed at baseline [ Time Frame: At week 0 ]
    Maximal walking speed at baseline. Assessed using 10-meter walking trial.
  • Maximal walking speed at week 14 [ Time Frame: At week 14 ]
    Maximal walking speed at week 14. Assessed using 10-meter walking trial.
  • Preferred walking speed at baseline [ Time Frame: At week 0 ]
    Baseline preferred walking speed. Assessed using 10-meter walking trial
  • Preferred walking speed at week 14 [ Time Frame: At week 14 ]
    Preferred walking speed at week 14. Assessed using 10-meter walking trial
  • Baseline walking economy [ Time Frame: At week 0 ]
    Baseline metabolic energy cost required to travel unit distance. Measured during walking using indirect calorimetry.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Knee joint loading at baseline [ Time Frame: At week 0 ]
    Knee joint loading during walking assessed at baseline. Estimated using musculoskeletal modeling and simulation.
  • 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.
  • 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.
  • Maximal walking speed at baseline [ Time Frame: At week 0 ]
    Maximal walking speed at baseline. Assessed using 10-meter walking trial.
  • Maximal walking speed at week 14 [ Time Frame: At week 14 ]
    Maximal walking speed at week 14. Assessed using 10-meter walking trial.
  • Maximal walking speed at week 28 [ Time Frame: At week 28 ]
    Maximal walking speed at week 28. Assessed using 10-meter walking trial.
  • Preferred walking speed at baseline [ Time Frame: At week 0 ]
    Baseline preferred walking speed. Assessed using 10-meter walking trial
  • Preferred walking speed at week 14 [ Time Frame: At week 14 ]
    Preferred walking speed at week 14. Assessed using 10-meter walking trial
  • Preferred walking speed at week 28 [ Time Frame: At week 28 ]
    Preferred walking speed at week 28. Assessed using 10-meter walking trial
  • Baseline walking economy [ Time Frame: At week 0 ]
    Baseline metabolic energy cost required to travel unit distance. Measured during walking using indirect calorimetry.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
  • Muscle strength [ Time Frame: Up to week 14 ]
    Ankle plantarflexor muscle strength assessed using maximal isometric contractions.
  • 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.
  • Achilles tendon stiffness [ Time Frame: At weeks 0 and 14 ]
    Achilles tendon stiffness evaluated using combination of ultrasonography, motion analysis and force measurements.
  • 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.
  • Muscle-tendon function during walking [ Time Frame: At weeks 0 and 14 ]
    Muscle fascicle kinematics measured using dynamics ultrasonography during walking.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Muscle strength [ Time Frame: Up to week 28 ]
    Ankle plantarflexor muscle strength assessed using maximal isometric contractions.
  • 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.
  • Achilles tendon stiffness [ Time Frame: At weeks 0, 14 and 28 ]
    Achilles tendon stiffness evaluated using combination of ultrasonography, motion analysis and force measurements.
  • 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.
  • Muscle-tendon function during walking [ Time Frame: At weeks 0, 14 and 28 ]
    Muscle fascicle kinematics measured using dynamics ultrasonography during walking.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Improved Calf Muscle Function on Gait, Balance and Joint Loading in Older Adults
Official Title  ICMJE Improving Plantarflexor Muscle Function to Alleviate Decline in Mobility, Loss of Balance and Detrimental Knee Joint Loading in Older Adults
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Osteoarthritis, Knee
  • Mobility Limitation
  • Accidental Fall
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Strength training + biofeedback
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: April 18, 2019) 		45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03921801
Other Study ID Numbers  ICMJE LS_Plantarflex
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Lauri Stenroth, University of Eastern Finland
Study Sponsor  ICMJE University of Eastern Finland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lauri Stenroth, PhD University of Eastern Finland
PRS Account University of Eastern Finland
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯