AgingTAGENCT03079180
Tendon Adaptations to Training - Effect of Ageing
A study testing Strength training at 80% 1RM and Strength training at 55% 1RM in people with Aging and Exercise Training, run by Université de Technologie de Compiegne at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aging, Exercise Training, Connective Tissue
- What is being tested?
- Strength training at 80% 1RM and Strength training at 55% 1RM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2017to 28 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- BMI <20 or >28
- Height <155cm, >195cm
- Chronic disease with regular clinical treatment
- Regular drug intake
- Any metabolic or hormonal disorder
- Psychiatric conditions
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Strength Training Intensities on Achilles and Patellar Tendon Adaptations With Aging
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.
Read the 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.
- Conditions
- Aging, Exercise Training, Connective Tissue, Skeletal Muscle
- Being tested
- Strength training at 80% 1RM, Strength training at 55% 1RM
- Keywords
- Tendon, Ageing, Training, Achilles tendon, Patella tendon, Skeletal muscle, Adaptation, Triceps Surae, Quadriceps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training at 80% 1RMOther
Detailed in Arms section's
Strength training at 55% 1RMOther
Detailed in Arms section's
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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 Receives: Other: Strength training at 55% 1RM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-course change of tendon size
Tendon size (tendon length and cross sectional area (CSA)) will be assessed using MRI.
Measured: 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.
Measured: 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
Plantar flexion muscle strength will be assessed using a specifically designed ankle ergometer under isometric contraction.
Measured: 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
Calf muscle size (i.e. cross sectional area and volume) will be assessed using MRI.
Measured: 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
Quadriceps muscle strength will be assessed using a specifically designed knee ergometer under isometric contraction.
Measured: 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
Quadriceps muscle size (i.e. cross sectional area and volume) will be assessed using MRI.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start13 Feb 2017
- Primary completion28 Jul 2017 (estimated)
- Study completion28 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Technologie de Compiegne
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Intercommunal de Compiègne-Noyon, University of Copenhagen
- Responsible party
- Principal investigator, Jean-Francois GROSSET, Université de Technologie de Compiegne
- Investigators
- Franck Mabesoone, MD, Principal investigator, Centre Hospitalier Compiegne-Noyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079180
- Sponsor's protocol ID
- 2016-A00534-47
- Acronym
- TAGE
- Status last verified
- Mar 2017
- First submitted
- 9 Feb 2017
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33441116
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Strength Training Intensities on Achilles and Patellar Tendon Adaptations With Aging
- ClinicalTrials.gov ID
- NCT03079180
- Acronym / sponsor ID
- TAGE / 2016-A00534-47
- Conditions
- Aging, Exercise Training, Connective Tissue, Skeletal Muscle
- Keywords
- Tendon, Ageing, Training, Achilles tendon, Patella tendon, Skeletal muscle, Adaptation, Triceps Surae
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Université de Technologie de CompiegneUniversity, hospital or other
- Collaborators
- Centre Hospitalier Intercommunal de Compiègne-Noyon, University of Copenhagen
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 28 Jul 2017 (estimated)
- Study completion
- 28 Jul 2017 (estimated)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aged & strength training at 80% 1RM | Experimental | Other: Strength training at 80% 1RMSubjects: 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. |
| Aged & strength training at 55% 1RM | Experimental | Other: Strength training at 55% 1RMSubjects: 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). |
| Young & strength training at 55% 1RM | Experimental | Other: Strength training at 55% 1RMSubjects: 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- BMI <20 or >28
- Height <155cm, >195cm
- Chronic disease with regular clinical treatment
- Regular drug intake
- Any metabolic or hormonal disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength training at 80% 1RMDetailed in Arms section's | Other | Aged & strength training at 80% 1RM |
| Strength training at 55% 1RMDetailed in Arms section's | Other | Aged & strength training at 55% 1RM, Young & strength training at 55% 1RM |
Primary outcome
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.
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.
4 secondary outcomes
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Derived from this study: PubMed 33441116Letocart 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franck Mabesoone, MD principal investigator
Centre Hospitalier Compiegne-Noyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training at 80% 1RM and Strength training at 55% 1RM in people with Aging and Exercise Training, run by Université de Technologie de Compiegne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03079180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.