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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03724461
Other study ID # DEP2015-69386-R
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date March 12, 2020

Study information

Verified date June 2020
Source University of Castilla-La Mancha
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There are no unbiased studies that have analyzed the effects of resistance training with traditional, heavy versus light-moderate loads on muscle, tendon and bone in elderly people.

The purpose of the present study is to assess the effects on muscle mass and function, tendon and bone of two different training intensities, light-moderate vs. heavy load, in people older than 65 years old.

The study will be carried out with a randomized controlled design. Participants will perform single training sessions and a 12-wk dynamic resistance training program on the knee extensors with different training intensities on each leg. One leg will train with heavy loads and the other one will train with light-moderate loads, but matching the load x repetitions performed by the contralateral side.


Description:

The decline in muscle function provoked by the aging process and frailty are directly related to decreases in mobility and the ability to perform the so called "daily life activities". Resistance training is especially useful at this stage, given that it is an effective and widely applicable intervention to control and revert sarcopenia, and the deterioration of tendon and bone function. Despite of the effectiveness of heavy load resistance training, a controversy has arisen in the last years about the effects of lower load resistance training programs to achieve similar adaptations. This is because most of the studies that have compared light-moderate versus heavy load programs did not control the differences in total training load, measured as the overall mechanical work performed during the training program. Therefore, there are no unbiased studies that have analyzed the effects of resistance training with traditional, heavy versus light-moderate loads on muscle, tendon and bone in elderly people.

The purpose of the present study is to assess the effects on muscle mass and function, tendon and bone of two different training intensities, light-moderate vs. heavy load, in people older than 65 years old.

The studies will be carried out with a crossover (acute training sessions) and randomized controlled design (longitudinal training intervention). Participants will perform single training sessions with each resistance training intensity and a 12-wk dynamic resistance training program on the knee extensors with different training intensities on each leg. One leg will train with heavy loads and the other one will train with light-moderate loads, but matching the load x repetitions performed by the contralateral side. Muscle adaptations (EMG, muscle size and architecture), tendon mechanical properties, bone mineral density, blood parameters and life quality will be analyzed before and after the cessation of the training program.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date March 12, 2020
Est. primary completion date March 12, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- 65 years and older,

- non-institutionalized

- passed physical examination including physical function assessment (no frailty status; SPPB >7 points)

Exclusion Criteria:

- Neurological, musculoskeletal, or other disorder that would preclude completing resistance training and all performance tests

- Uncontrolled hypertension, unstable or exercise-induced angina pectoris or myocardial ischemia or any other medical condition that would interfere with testing or increase one's risk of complications during exercise.

- History of regular resistance exercise during the previous 3 years

- Knee prosthesis

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
High Intensity resistance training (12 weeks)
High intensity resistance training (80% of 1 repetition maximum), 2 d/wk (Longitudinal)
Light-moderate intensity resistance training (12 weeks)
Light-moderate intensity resistance training (40% of 1 repetition maximum), 2 d/wk (Longitudinal)
Control (12 weeks)
No resistance training during the intervention period.
One High Intensity resistance training session
High intensity resistance training, 1 training session
One Light-moderate intensity resistance training session
Light-moderate intensity resistance training, 1 training session

Locations

Country Name City State
Spain Universidad de Castilla-La Mancha, Laboratorio de Actividad Física y Función Muscular. Campus de la Fábrica de Armas. Avda. Carlos III s/n Toledo

Sponsors (3)

Lead Sponsor Collaborator
University of Castilla-La Mancha Biomedical Research Networking Center on Frailty and Healthy Aging (CIBERFES), Ministerio de Economía y Competitividad, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute change in muscle size (cross sectional area, cm2) Ultrasound-based determination quadriceps muscle size and architecture. Change from baseline at 5 minutes after a training session
Primary Change in muscle size (cross sectional area, cm2) Ultrasound-based determination quadriceps muscle size and architecture. Change from baseline to week 12
Primary Acute change in muscle function (N) Force-velocity profile of the single-leg press exercise Change from baseline at 5 minutes after a training session
Primary Change in muscle function (N) Force-velocity profile of the single-leg press exercise Change from baseline to week 12
Secondary Change in patellar tendon stiffness (N/mm) Ultrasound and force-based measures of tendon mechanical properties. Change from baseline to week 12
Secondary Acute change in patellar tendon stiffness (N/mm) Ultrasound and force-based measures of tendon mechanical properties. Change from baseline at 5 minutes after a training session
Secondary Change in muscle mass (kg) Lean mass determined by Dual energy X-ray absorptiometry Change from baseline to week 12
Secondary Change in bone mass (g) Bone mineral content determined by Dual energy X-ray absorptiometry Change from baseline to week 12
Secondary Acute change in muscle excitation (mV) Electromyographic activity of the knee extensor and flexor muscles during strength assessment and training Change from baseline at 5 minutes after a training session
Secondary Change in muscle excitation (mV) Electromyographic activity of the knee extensor and flexor muscles during strength assessment and training Change from baseline to week 12
Secondary Change in physical function Short Physical Performance Battery Change from baseline to week 12
Secondary Blood analysis: Acute change in oxidative stress Carbonyl proteins (plasma concentration) Change from baseline at 5 minutes after a training session
Secondary Blood analysis: Change in oxidative stress Carbonyl proteins (plasma concentration) Change from baseline to week 12
Secondary Blood analysis: Acute change in Inflammation Interleukin 6, Tumoral necrosis factor Alpha, C reactive protein (plasma concentration) Change from baseline at 5 minutes after a training session (Acute)
Secondary Blood analysis: Change in inflammation Interleukin 6, Tumoral necrosis factor Alpha, C reactive protein (plasma concentration) Change from baseline to week 12
Secondary Blood analysis: Acute change in anabolic processes Testosterone, growth hormone, Insulin growth factor-1 (plasma concentration) Change from baseline at 5 minutes after a training session
Secondary Blood analysis: Change in anabolic processes Testosterone, growth hormone, Insulin growth factor-1 (plasma concentration) Change from baseline to week 12
Secondary Blood analysis: Acute change in catabolic processes Cortisol, Creatin kinase (plasma concentration) Change from baseline at 5 minutes after a training session
Secondary Blood analysis: Change in catabolic processes Cortisol, Creatin kinase (plasma concentration) Change from baseline to week 12
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