- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03079180
Tendon Adaptations to Training - Effect of Ageing (TAGE)
Effect of Different Strength Training Intensities on Achilles and Patellar Tendon Adaptations With Aging
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Given the aging population demographics, and the barriers that exist in this population in terms of exercise participation, determining the level of exercise intensity required and the time-course to induce tendon adaptations is of paramount importance in this population. Therefore the purpose of this study is to:
- determine whether a low intensity exercise training program (resistance 55% 1RM) affects tendon architecture and mechanical properties with aging,
- compare these effects to those of a higher intensity exercise training protocol (resistance 80% 1RM) with a match training work with regards to the low intensity exercise training group,
- evaluate the time course of tendon adaptations (architecture and mechanical properties) for the two training conditions with aging,
- compare the effect of an identical training protocol applied on two different muscle groups (triceps surae vs quadriceps muscles) on Patellar and Achilles tendon adaptations.
Every subject recruited (Two groups composed of males aged between 65 and 85 years, and one group of young subjects (between 18 and 30 years)) will be asked to take part in a training program applied on the calf and quadriceps muscle groups on both legs. All subjects will be assessed 4 weeks before starting the intervention program (T-4w), at time zero (T0) and every four weeks during 12 weeks (T4w, and T8w). The investigation 4 weeks before starting the training program will allow using each subject as its own control. The intervention will involve a maximum of forty five (45) minutes training sessions 3 times per week. Subjects will be subjected to the same battery of baseline assessments (T-4w, and T0), during the training procedure (T4w, and T8w), and following the 12-weeks intervention period (T12w).
The effect of aging and different loading interventions on Achilles and Patellar tendon will be investigated for the following parameters:
- Tendon mechanical properties (stiffness and Young's Modulus) using US technique to assess Achilles and Patellar tendon displacement during an incremental maximal contraction.
- Tendon architecture using MRI technique to assess Achilles and Patellar tendon cross-sectional area, tendon length and moment arm.
- Maximal voluntary contraction (MVC)
- Muscle architecture using MRI technique.
Thus all these data will allow defining an optimal training intensity for physical activity of elderly persons.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Compiegne, France, 60200
- Universite de Technologie de Compiegne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Lower extremity trauma during the past 6 months, or currently experiencing related symptoms, or receiving treatment
- Any other condition or history that the investigator considers might increase the risk to the individual or interfere with the evaluation of data
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aged & strength training at 80% 1RM
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. |
Detailed in Arms section's
|
|
Experimental: Aged & strength training at 55% 1RM
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). |
Detailed in Arms section's
|
|
Experimental: Young & strength training at 55% 1RM
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 |
Detailed in Arms section's
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time-course change of tendon size
Time Frame: 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)
|
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)
Time Frame: 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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time-course change of plantar flexion muscle strength
Time Frame: 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)
|
Plantar flexion muscle strength will be assessed using a specifically designed ankle ergometer under isometric contraction.
|
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
Time Frame: 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)
|
Calf muscle size (i.e.
cross sectional area and volume) 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 quadriceps muscle strength
Time Frame: 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)
|
Quadriceps muscle strength will be assessed using a specifically designed knee ergometer under isometric contraction.
|
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
Time Frame: 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)
|
Quadriceps muscle size (i.e.
cross sectional area and volume) 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)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Franck Mabesoone, MD, Centre Hospitalier Compiègne-Noyon
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2016-A00534-47
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aging
-
Florida Institute for Human and Machine CognitionNot yet recruitingAging | Healthy Aging | Aging WellUnited States
-
Tuba MadenCompletedAging | Aging Problems | Aging Disorder
-
University of CopenhagenRecruitingAging | Healthy Aging | Aging FrailtyDenmark
-
Radboud University Medical CenterTerminated
-
Northwestern UniversityPotocsnak Human Longevity LabRecruitingAging | Aging Well | Aging, Biological | Aging, HealthyUnited States
-
Centre Hospitalier Universitaire de NiceNot yet recruitingAging | Aging, HealthyFrance
-
University of Santiago de CompostelaEuropean Regional Development Fund; Center for Industrial Technological Development...Completed
-
TruDiagnosticBlushield USANot yet recruitingAging | Aging Well
-
Arizona State UniversityActive, not recruiting
-
San Diego State UniversityCompleted
Clinical Trials on Strength training at 80% 1RM
-
Universiti Putra MalaysiaRecruiting
-
McMaster UniversityCompletedMuscle Weakness | Skeletal Muscle HypertrophyCanada
-
University of British ColumbiaEnrolling by invitationMuscle Hypertrophy | Muscular StrengthCanada
-
University of British ColumbiaNot yet recruitingMuscle Hypertrophy | Muscular Strength
-
Akdeniz UniversitySelcuk UniversityCompleted
-
University of MinnesotaCompletedPhysical InactivityUnited States
-
Umeå UniversityThe Swedish Research Council; Swedish Heart Lung Foundation; Riksförbundet HjärtLungCompletedCOPD | Healthy Older AdultsSweden
-
University of SevilleNot yet recruitingChild | Executive Function | Strength TrainingSpain
-
Federal University of Rio Grande do SulEnrolling by invitationInvestigating the Effects of Power Training in the ElderlyBrazil
-
Véronique PépinCanadian Institutes of Health Research (CIHR); Fonds de la Recherche en Santé... and other collaboratorsTerminated