- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03724461
Effects of Resistance Training With High vs. Light-moderate Loads on Muscle-tendon Function in the Elderly
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Toledo, Spain, 45071
- Universidad de Castilla-La Mancha, Laboratorio de Actividad Física y Función Muscular. Campus de la Fábrica de Armas. Avda. Carlos III s/n
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: High intensity vs Control (12 weeks)
8 weeks of baseline period plus an exercise program where one leg undergoes High Intensity resistance training (12 weeks) and the other leg is established as control.
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High intensity resistance training (80% of 1 repetition maximum), 2 d/wk (Longitudinal)
Other Names:
No resistance training during the intervention period.
Other Names:
|
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Active Comparator: Light intensity vs Control (12 weeks)
8 weeks of baseline period plus an exercise program where one leg undergoes light-moderate intensity resistance training (12 weeks) and the other leg is established as control.
|
No resistance training during the intervention period.
Other Names:
Light-moderate intensity resistance training (40% of 1 repetition maximum), 2 d/wk (Longitudinal)
Other Names:
|
|
Experimental: High vs Light intensity (12 weeks)
8 weeks of baseline period plus an exercise program where one leg undergoes High Intensity resistance training (12 weeks) and the other leg undergoes light-moderate intensity resistance training.
|
High intensity resistance training (80% of 1 repetition maximum), 2 d/wk (Longitudinal)
Other Names:
Light-moderate intensity resistance training (40% of 1 repetition maximum), 2 d/wk (Longitudinal)
Other Names:
|
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Experimental: High intensity (Acute)
Analysis of the effects of one High Intensity resistance training session, with a crossover design.
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High intensity resistance training, 1 training session
Other Names:
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Experimental: Light intensity (Acute)
Analysis of the effects of one Light-moderate Intensity resistance training session, with a crossover design.
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Light-moderate intensity resistance training, 1 training session
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acute change in muscle size (cross sectional area, cm2)
Time Frame: Change from baseline at 5 minutes after a training session
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Ultrasound-based determination quadriceps muscle size and architecture.
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Change from baseline at 5 minutes after a training session
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|
Change in muscle size (cross sectional area, cm2)
Time Frame: Change from baseline to week 12
|
Ultrasound-based determination quadriceps muscle size and architecture.
|
Change from baseline to week 12
|
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Acute change in muscle function (N)
Time Frame: Change from baseline at 5 minutes after a training session
|
Force-velocity profile of the single-leg press exercise
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Change from baseline at 5 minutes after a training session
|
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Change in muscle function (N)
Time Frame: Change from baseline to week 12
|
Force-velocity profile of the single-leg press exercise
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Change from baseline to week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in patellar tendon stiffness (N/mm)
Time Frame: Change from baseline to week 12
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Ultrasound and force-based measures of tendon mechanical properties.
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Change from baseline to week 12
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Acute change in patellar tendon stiffness (N/mm)
Time Frame: Change from baseline at 5 minutes after a training session
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Ultrasound and force-based measures of tendon mechanical properties.
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Change from baseline at 5 minutes after a training session
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Change in muscle mass (kg)
Time Frame: Change from baseline to week 12
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Lean mass determined by Dual energy X-ray absorptiometry
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Change from baseline to week 12
|
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Change in bone mass (g)
Time Frame: Change from baseline to week 12
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Bone mineral content determined by Dual energy X-ray absorptiometry
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Change from baseline to week 12
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Acute change in muscle excitation (mV)
Time Frame: Change from baseline at 5 minutes after a training session
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Electromyographic activity of the knee extensor and flexor muscles during strength assessment and training
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Change from baseline at 5 minutes after a training session
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Change in muscle excitation (mV)
Time Frame: Change from baseline to week 12
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Electromyographic activity of the knee extensor and flexor muscles during strength assessment and training
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Change from baseline to week 12
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Change in physical function
Time Frame: Change from baseline to week 12
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Short Physical Performance Battery
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Change from baseline to week 12
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Blood analysis: Acute change in oxidative stress
Time Frame: Change from baseline at 5 minutes after a training session
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Carbonyl proteins (plasma concentration)
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Change from baseline at 5 minutes after a training session
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Blood analysis: Change in oxidative stress
Time Frame: Change from baseline to week 12
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Carbonyl proteins (plasma concentration)
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Change from baseline to week 12
|
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Blood analysis: Acute change in Inflammation
Time Frame: Change from baseline at 5 minutes after a training session (Acute)
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Interleukin 6, Tumoral necrosis factor Alpha, C reactive protein (plasma concentration)
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Change from baseline at 5 minutes after a training session (Acute)
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Blood analysis: Change in inflammation
Time Frame: Change from baseline to week 12
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Interleukin 6, Tumoral necrosis factor Alpha, C reactive protein (plasma concentration)
|
Change from baseline to week 12
|
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Blood analysis: Acute change in anabolic processes
Time Frame: Change from baseline at 5 minutes after a training session
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Testosterone, growth hormone, Insulin growth factor-1 (plasma concentration)
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Change from baseline at 5 minutes after a training session
|
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Blood analysis: Change in anabolic processes
Time Frame: Change from baseline to week 12
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Testosterone, growth hormone, Insulin growth factor-1 (plasma concentration)
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Change from baseline to week 12
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Blood analysis: Acute change in catabolic processes
Time Frame: Change from baseline at 5 minutes after a training session
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Cortisol, Creatin kinase (plasma concentration)
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Change from baseline at 5 minutes after a training session
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Blood analysis: Change in catabolic processes
Time Frame: Change from baseline to week 12
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Cortisol, Creatin kinase (plasma concentration)
|
Change from baseline to week 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Luis M. Alegre, PhD, Associate professor
Publications and helpful links
General Publications
- Rodriguez-Lopez C, Alcazar J, Losa-Reyna J, Martin-Espinosa NM, Baltasar-Fernandez I, Ara I, Csapo R, Alegre LM. Effects of Power-Oriented Resistance Training With Heavy vs. Light Loads on Muscle-Tendon Function in Older Adults: A Study Protocol for a Randomized Controlled Trial. Front Physiol. 2021 Feb 18;12:635094. doi: 10.3389/fphys.2021.635094. eCollection 2021.
- Rodriguez-Lopez C, Alcazar J, Sanchez-Martin C, Ara I, Csapo R, Alegre LM. Mechanical Characteristics of Heavy vs. Light Load Ballistic Resistance Training in Older Adults. J Strength Cond Res. 2022 Aug 1;36(8):2094-2101. doi: 10.1519/JSC.0000000000003826. Epub 2020 Sep 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEP2015-69386-R
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.
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