AgingNCT03724461
Effects of Resistance Training With High vs. Light-moderate Loads on Muscle-tendon Function in the Elderly
A study testing High Intensity resistance training (12 weeks), Light-moderate intensity resistance training (12 weeks) and One High Intensity resistance training session in people with Aging and Sarcopenia, run by University of Castilla-La Mancha at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Sarcopenia, Frail Elderly Syndrome
- What is being tested?
- High Intensity resistance training (12 weeks), Light-moderate intensity resistance training (12 weeks) and One High Intensity resistance training session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2017to 12 Mar 2020
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years and older,
- non-institutionalized
- passed physical examination including physical function assessment (no frailty status; SPPB >7 points)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad de Castilla-La Mancha, Laboratorio de Actividad Física y Función Muscular. Campus de la Fábrica de Armas. Avda. Carlos III s/n
Toledo, 45071
About this study
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.
Read the 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.
- Conditions
- Aging, Sarcopenia, Frail Elderly Syndrome
- Being tested
- High Intensity resistance training (12 weeks), Light-moderate intensity resistance training (12 weeks), Control (12 weeks), One High Intensity resistance training session, One Light-moderate intensity resistance training session
- Keywords
- resistance training, sarcopenia, hypertrophy, tendon, frailty, ageing
- Medical subject headings
- Sarcopenia, Hypertrophy, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity resistance training (12 weeks)Behavioural
Also called HIT
High intensity resistance training (80% of 1 repetition maximum), 2 d/wk (Longitudinal)
Light-moderate intensity resistance training (12 weeks)Behavioural
Also called LIT
Light-moderate intensity resistance training (40% of 1 repetition maximum), 2 d/wk (Longitudinal)
Control (12 weeks)Behavioural
Also called CON
No resistance training during the intervention period.
One High Intensity resistance training sessionBehavioural
Also called HIT (Acute)
High intensity resistance training, 1 training session
One Light-moderate intensity resistance training sessionBehavioural
Also called LIT (Acute)
Light-moderate intensity resistance training, 1 training session
| Study group | Role | What they receive |
|---|---|---|
| High intensity vs Control (12 weeks) | Active comparator | 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. Receives: Behavioral: High Intensity resistance training (12 weeks); Behavioral: Control (12 weeks) |
| Light intensity vs Control (12 weeks) | Active comparator | 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. Receives: Behavioral: Light-moderate intensity resistance training (12 weeks); Behavioral: Control (12 weeks) |
| High vs Light intensity (12 weeks) | Experimental | 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. Receives: Behavioral: High Intensity resistance training (12 weeks); Behavioral: Light-moderate intensity resistance training (12 weeks) |
| High intensity (Acute) | Experimental | Analysis of the effects of one High Intensity resistance training session, with a crossover design. Receives: Behavioral: One High Intensity resistance training session |
| Light intensity (Acute) | Experimental | Analysis of the effects of one Light-moderate Intensity resistance training session, with a crossover design. Receives: Behavioral: One Light-moderate intensity resistance training session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute change in muscle size (cross sectional area, cm2)
Ultrasound-based determination quadriceps muscle size and architecture.
Measured: Change from baseline at 5 minutes after a training session
Change in muscle size (cross sectional area, cm2)
Ultrasound-based determination quadriceps muscle size and architecture.
Measured: Change from baseline to week 12
Acute change in muscle function (N)
Force-velocity profile of the single-leg press exercise
Measured: Change from baseline at 5 minutes after a training session
Change in muscle function (N)
Force-velocity profile of the single-leg press exercise
Measured: Change from baseline to week 12
Secondary outcomes (15)
Change in patellar tendon stiffness (N/mm)
Ultrasound and force-based measures of tendon mechanical properties.
Measured: Change from baseline to week 12
Acute change in patellar tendon stiffness (N/mm)
Ultrasound and force-based measures of tendon mechanical properties.
Measured: Change from baseline at 5 minutes after a training session
Change in muscle mass (kg)
Lean mass determined by Dual energy X-ray absorptiometry
Measured: Change from baseline to week 12
Change in bone mass (g)
Bone mineral content determined by Dual energy X-ray absorptiometry
Measured: Change from baseline to week 12
Acute change in muscle excitation (mV)
Electromyographic activity of the knee extensor and flexor muscles during strength assessment and training
Measured: Change from baseline at 5 minutes after a training session
Change in muscle excitation (mV)
Electromyographic activity of the knee extensor and flexor muscles during strength assessment and training
Measured: Change from baseline to week 12
Change in physical function
Short Physical Performance Battery
Measured: Change from baseline to week 12
Blood analysis: Acute change in oxidative stress
Carbonyl proteins (plasma concentration)
Measured: Change from baseline at 5 minutes after a training session
Blood analysis: Change in oxidative stress
Carbonyl proteins (plasma concentration)
Measured: Change from baseline to week 12
Blood analysis: Acute change in Inflammation
Interleukin 6, Tumoral necrosis factor Alpha, C reactive protein (plasma concentration)
Measured: Change from baseline at 5 minutes after a training session (Acute)
Blood analysis: Change in inflammation
Interleukin 6, Tumoral necrosis factor Alpha, C reactive protein (plasma concentration)
Measured: Change from baseline to week 12
Blood analysis: Acute change in anabolic processes
Testosterone, growth hormone, Insulin growth factor-1 (plasma concentration)
Measured: Change from baseline at 5 minutes after a training session
Blood analysis: Change in anabolic processes
Testosterone, growth hormone, Insulin growth factor-1 (plasma concentration)
Measured: Change from baseline to week 12
Blood analysis: Acute change in catabolic processes
Cortisol, Creatin kinase (plasma concentration)
Measured: Change from baseline at 5 minutes after a training session
Blood analysis: Change in catabolic processes
Cortisol, Creatin kinase (plasma concentration)
Measured: Change from baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Sep 2017
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, Biomedical Research Networking Center on Frailty and Healthy Aging (CIBERFES)
- Responsible party
- Principal investigator, Luis M. Alegre, University of Castilla-La Mancha
- Investigators
- Luis M. Alegre, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724461
- Sponsor's protocol ID
- DEP2015-69386-R
- Status last verified
- Jun 2020
- First submitted
- 18 Sep 2018
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rodriguez-Lopez C, Alcazar J, Sanchez-Martin C, Baltasar-Fernandez I, Ara I, Csapo R, Alegre LM. Contralateral Adaptations After Unilateral Power Training in Older Adults: The Effect of Intensity of Load. Scand J Med Sci Sports. 2025 Nov;35(11):e70165. doi: 10.1111/sms.70165.
PubMed 41222282Rodriguez-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.
PubMed 33679447Rodriguez-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.
PubMed 32947572
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Training With High vs. Light-moderate Loads on Muscle-tendon Function in the Elderly
- ClinicalTrials.gov ID
- NCT03724461
- Acronym / sponsor ID
- DEP2015-69386-R
- Conditions
- Aging, Sarcopenia, Frail Elderly Syndrome
- Keywords
- resistance training, sarcopenia, hypertrophy, tendon, frailty, ageing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, Biomedical Research Networking Center on Frailty and Healthy Aging (CIBERFES)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 30 Oct 2018 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| High intensity vs Control (12 weeks) | Active comparator | Behavioral: High Intensity resistance training (12 weeks), Behavioral: 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. |
| Light intensity vs Control (12 weeks) | Active comparator | Behavioral: Light-moderate intensity resistance training (12 weeks), Behavioral: 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. |
| High vs Light intensity (12 weeks) | Experimental | Behavioral: High Intensity resistance training (12 weeks), Behavioral: Light-moderate intensity resistance training (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 (Acute) | Experimental | Behavioral: One High Intensity resistance training sessionAnalysis of the effects of one High Intensity resistance training session, with a crossover design. |
| Light intensity (Acute) | Experimental | Behavioral: One Light-moderate intensity resistance training sessionAnalysis of the effects of one Light-moderate Intensity resistance training session, with a crossover design. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 years and older,
- non-institutionalized
- passed physical examination including physical function assessment (no frailty status; SPPB >7 points)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| High Intensity resistance training (12 weeks)Also: HITHigh intensity resistance training (80% of 1 repetition maximum), 2 d/wk (Longitudinal) | Behavioural | High intensity vs Control (12 weeks), High vs Light intensity (12 weeks) |
| Light-moderate intensity resistance training (12 weeks)Also: LITLight-moderate intensity resistance training (40% of 1 repetition maximum), 2 d/wk (Longitudinal) | Behavioural | High vs Light intensity (12 weeks), Light intensity vs Control (12 weeks) |
| Control (12 weeks)Also: CONNo resistance training during the intervention period. | Behavioural | High intensity vs Control (12 weeks), Light intensity vs Control (12 weeks) |
| One High Intensity resistance training sessionAlso: HIT (Acute)High intensity resistance training, 1 training session | Behavioural | High intensity (Acute) |
| One Light-moderate intensity resistance training sessionAlso: LIT (Acute)Light-moderate intensity resistance training, 1 training session | Behavioural | Light intensity (Acute) |
Primary outcome
Acute change in muscle size (cross sectional area, cm2)
Time frame: Change from baseline at 5 minutes after a training session
Ultrasound-based determination quadriceps muscle size and architecture.
Change in muscle size (cross sectional area, cm2)
Time frame: Change from baseline to week 12
Ultrasound-based determination quadriceps muscle size and architecture.
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
Change in muscle function (N)
Time frame: Change from baseline to week 12
Force-velocity profile of the single-leg press exercise
15 secondary outcomes
Change in patellar tendon stiffness (N/mm)
Time frame: Change from baseline to week 12
Acute change in patellar tendon stiffness (N/mm)
Time frame: Change from baseline at 5 minutes after a training session
Change in muscle mass (kg)
Time frame: Change from baseline to week 12
Change in bone mass (g)
Time frame: Change from baseline to week 12
Acute change in muscle excitation (mV)
Time frame: Change from baseline at 5 minutes after a training session
Change in muscle excitation (mV)
Time frame: Change from baseline to week 12
Change in physical function
Time frame: Change from baseline to week 12
Blood analysis: Acute change in oxidative stress
Time frame: Change from baseline at 5 minutes after a training session
Blood analysis: Change in oxidative stress
Time frame: Change from baseline to week 12
Blood analysis: Acute change in Inflammation
Time frame: Change from baseline at 5 minutes after a training session (Acute)
Blood analysis: Change in inflammation
Time frame: Change from baseline to week 12
Blood analysis: Acute change in anabolic processes
Time frame: Change from baseline at 5 minutes after a training session
Blood analysis: Change in anabolic processes
Time frame: Change from baseline to week 12
Blood analysis: Acute change in catabolic processes
Time frame: Change from baseline at 5 minutes after a training session
Blood analysis: Change in catabolic processes
Time frame: Change from baseline to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Derived from this study: PubMed 41222282Rodriguez-Lopez C, Alcazar J, Sanchez-Martin C, Baltasar-Fernandez I, Ara I, Csapo R, Alegre LM. Contralateral Adaptations After Unilateral Power Training in Older Adults: The Effect of Intensity of Load. Scand J Med Sci Sports. 2025 Nov;35(11):e70165. doi: 10.1111/sms.70165.
- Derived from this study: PubMed 33679447Rodriguez-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.
- Derived from this study: PubMed 32947572Rodriguez-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.
- Individual participant dataSharing planned: Undecided
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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.
Luis M. Alegre, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity resistance training (12 weeks), Light-moderate intensity resistance training (12 weeks) and One High Intensity resistance training session in people with Aging and Sarcopenia, run by University of Castilla-La Mancha at 1 site in Spain.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 16 Jun 2020. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute change in muscle size (cross sectional area, cm2) (time frame: Change from baseline at 5 minutes after a training session). The study lists 4 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 NCT03724461, which also lists 3 linked publications.
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 16 Jun 2020.