Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03079180
Other study ID # 2016-A00534-47
Secondary ID
Status Enrolling by invitation
Phase N/A
First received February 9, 2017
Last updated March 7, 2017
Start date February 13, 2017
Est. completion date July 28, 2017

Study information

Verified date March 2017
Source Université de Technologie de Compiegne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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:

1. determine whether a low intensity exercise training program (resistance 55% 1RM) affects tendon architecture and mechanical properties with aging,

2. 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,

3. evaluate the time course of tendon adaptations (architecture and mechanical properties) for the two training conditions with aging,

4. 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date July 28, 2017
Est. primary completion date July 28, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Strength training at 80% 1RM
Detailed in Arms section's
Strength training at 55% 1RM
Detailed in Arms section's

Locations

Country Name City State
France Universite de Technologie de Compiegne Compiegne

Sponsors (3)

Lead Sponsor Collaborator
Université de Technologie de Compiegne Centre Hospitalier Compiègne-Noyon, University of Copenhagen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 Time-course change of plantar flexion muscle strength 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)
Secondary Time-course change of calf muscle size 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)
Secondary Time-course change of quadriceps muscle strength 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)
Secondary Time-course change of quadriceps muscle size 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)
See also
  Status Clinical Trial Phase
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Completed NCT05293730 - Trial of the Impact of the Electronic Frailty Integrated With Social Needs N/A
Recruiting NCT03932162 - Gene Expression Changes In Young and Geriatric Skin Early Phase 1
Completed NCT04064528 - Effects of Age on Amino Acid Delivery to Tendon N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT06029920 - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment N/A
Recruiting NCT05566938 - Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly N/A
Recruiting NCT05543980 - Leg Heat Therapy in Elderly Individuals Phase 2
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Not yet recruiting NCT06071130 - Emotion, Aging, and Decision Making N/A
Enrolling by invitation NCT04641663 - Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST) N/A
Completed NCT04088006 - The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity N/A
Completed NCT03695081 - Patient Pathway Pharmacist - Optimal Drug-related Care N/A
Recruiting NCT05424263 - Acetate and Age-associated Arterial Dysfunction Phase 2
Completed NCT05601713 - Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling N/A
Completed NCT04551339 - Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19 N/A
Recruiting NCT04997577 - Speech Perception and High Cognitive Demand N/A
Completed NCT05922475 - Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A