NCT03079180

Brief Summary

Tendons are essential structures for transmitting muscle forces to skeletal structures. A stiffer tendon will transmit muscle force faster, and then allow faster movement. Moreover, tendons are a living tissue and respond to mechanical forces by changing their metabolism as well as their structural and mechanical properties. The aim of the present study is to answer essential questions remaining unanswered that are necessary in order to optimize physical activity with ageing in humans, and thus improve quality of life in elderly. The main questions are: What is the minimal training intensity leading to tendon adaptations? What is the time-course of tendon adaptations? Does the same loading protocol lead to similar tendon adaptations for different tendons (Achilles vs Patellar) and does the same training program lead to identical tendon adaptations with age (25yrs vs 75yrs)? To answer these questions, tendon architecture and mechanical properties will be investigated in humans of different age and applying different training intensities. The kinematic of the tendon adaptations due to these different training characteristics will also be investigated. The training protocol will be applied on plantar flexors and knee extensors. MRI and ultrasound techniques as well as the use of ankle and knee ergometers will allow the quantification of possible modifications in tendon architecture and mechanical properties (tendon stiffness and Young's Modulus). This will be assessed in vivo, using ultrasound images to assess tendon displacement during an incremental maximal contraction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

February 13, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2017

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

6 months

First QC Date

February 9, 2017

Last Update Submit

March 7, 2017

Conditions

Keywords

TendonAgeingTrainingAchilles tendonPatella tendonSkeletal muscleAdaptationTriceps SuraeQuadriceps

Outcome Measures

Primary Outcomes (2)

  • Time-course change of tendon size

    Tendon size (tendon length and cross sectional area (CSA)) will be assessed using MRI.

    T-4weeks (4 weeks before starting intervention), T0 (before starting intervention), T+4weeks (after 4 weeks of intervention), T+8weeks (after 8 weeks of intervention), T+12weeks (at the end of the 12 weeks of intervention)

  • Time-course change of tendon mechanics (Elastic modulus of the tendon)

    Tendon stiffness will be evaluated during voluntary plantar flexion contraction where force and elongation is measured using a force transducer and ultrasound, respectively. Tendon size will be assessed using MRI. Elastic modulus will be calculated based on stiffness and size of tendon.

    T-4weeks (4 weeks before starting intervention), T0 (before starting intervention), T+4weeks (after 4 weeks of intervention), T+8weeks (after 8 weeks of intervention), T+12weeks (at the end of the 12 weeks of intervention)

Secondary Outcomes (4)

  • Time-course change of plantar flexion muscle strength

    T-4weeks (4 weeks before starting intervention), T0 (before starting intervention), T+4weeks (after 4 weeks of intervention), T+8weeks (after 8 weeks of intervention), T+12weeks (at the end of the 12 weeks of intervention)

  • Time-course change of calf muscle size

    T-4weeks (4 weeks before starting intervention), T0 (before starting intervention), T+4weeks (after 4 weeks of intervention), T+8weeks (after 8 weeks of intervention), T+12weeks (at the end of the 12 weeks of intervention)

  • Time-course change of quadriceps muscle strength

    T-4weeks (4 weeks before starting intervention), T0 (before starting intervention), T+4weeks (after 4 weeks of intervention), T+8weeks (after 8 weeks of intervention), T+12weeks (at the end of the 12 weeks of intervention)

  • Time-course change of quadriceps muscle size

    T-4weeks (4 weeks before starting intervention), T0 (before starting intervention), T+4weeks (after 4 weeks of intervention), T+8weeks (after 8 weeks of intervention), T+12weeks (at the end of the 12 weeks of intervention)

Study Arms (3)

Aged & strength training at 80% 1RM

EXPERIMENTAL

Subjects: 20 subjects aged between 65 and 85 years Training programs: Frequency: 3 training sessions per week. Duration: 12 weeks. Intensity: 80% of one repetition maximum (1RM). The 1RM of the participants in each of the 3 exercises performed in the training program will be reviewed every 2 weeks during training. If 1RM increase, the training load will be adjusted accordingly. Training exercises: A Warm-up will first be performed on a cycle ergometer during 10min. The training intervention will then consist in performing two sets on each one of the two exercises used for Patellar tendon stress: leg extension and leg press. To stress Achilles tendon, the subjects will perform four (4) sets using a calf raise machine. The subjects will perform 4 to 8 repetitions at 80% 1RM. All training sessions will take place under appropriate supervision in UTC for the duration of the interventions according to the study design.

Other: Strength training at 80% 1RM

Aged & strength training at 55% 1RM

EXPERIMENTAL

Subjects: 20 subjects aged between 65 and 85 years The training program and training exercises in this group are the same as for the Aged \& strength training at 80% 1RM arm except for the two following parameters. Training intensity: Intensity of exercises will be 55% of one repetition maximum (1RM). The subjects will perform 6 to 12 repetitions at 55% 1RM. The two training programs (55% or 80% of 1RM) are designed to be equal in volume (resistance x repetitions x sets).

Other: Strength training at 55% 1RM

Young & strength training at 55% 1RM

EXPERIMENTAL

Subjects: 20 subjects aged between 18 and 30 years The training program and training exercises in this group are the same as for the Aged \& strength training at 55% 1RM arm

Other: Strength training at 55% 1RM

Interventions

Detailed in Arms section's

Aged & strength training at 80% 1RM

Detailed in Arms section's

Aged & strength training at 55% 1RMYoung & strength training at 55% 1RM

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males
  • Age between 18 and 30 years for the young group and between 65 and 85 years for aged group
  • Physical and mental health, as assessed by clinical investigation
  • Written informed consent
  • Willingness to co-operate
  • Non-smoker
  • Not addicted to alcohol or drugs
  • Habitual sedentary/low physical activity levels

You may not qualify if:

  • BMI \<20 or \>28
  • Height \<155cm, \>195cm
  • Chronic disease with regular clinical treatment
  • Regular drug intake
  • Any metabolic or hormonal disorder
  • Psychiatric conditions
  • Any blood clotting disorder
  • Any muscle or bone disease
  • Metal implants
  • Any inflammatory disease
  • Metabolic or hormonal disorder
  • Participation in sports at competitive rather than at a recreational level
  • Fractures during the past 6 months
  • Epilepsy
  • Back pain
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universite de Technologie de Compiegne

Compiègne, 60200, France

Location

Related Publications (1)

  • Letocart AJ, Mabesoone F, Charleux F, Couppe C, Svensson RB, Marin F, Magnusson SP, Grosset JF. Muscles adaptation to aging and training: architectural changes - a randomised trial. BMC Geriatr. 2021 Jan 13;21(1):48. doi: 10.1186/s12877-020-02000-0.

Study Officials

  • Franck Mabesoone, MD

    Centre Hospitalier Compiegne-Noyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (PhD)

Study Record Dates

First Submitted

February 9, 2017

First Posted

March 14, 2017

Study Start

February 13, 2017

Primary Completion

July 28, 2017

Study Completion

July 28, 2017

Last Updated

March 14, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations