SarcopeniaSarcoImageNCT03834558
Imaging Biomarkers of the Effects of a Mixed Exercise Program
A study testing Mixed exercise program in people with Sarcopenia, run by University of Valencia at 1 site in Spain.
Trial summary
The aim is quantify, correlate and establish the diagnostic and prognostic value of the variation of the image biomarkers obtained by magnetic resonance (muscle volume, morphological, biochemical and structural biomarkers) longitudinally in fragile or pre-frail elders with sarcopenia after a mixed physical training of… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Mixed exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 6 Feb 2019to 2 Nov 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients of both genders,
- aged 70 years old or more,
- with habitual residence in Valencia,
- with independent wandering (they can have technical aids, but not from someone else)
- that meets Fried's pre-frailty or frailty criteria
- EGWSOP's sarcopenia criteria
- who has agreed to participate in the study and signed the informed consent
Who cannot join
- Patients with life expectancy less than six months
- Institutionalized patients
- Patients with severe visual or auditory deficits
- Patients with contraindication in the performance of physical exercise (cardiovascular risk factors)
- Patients with contraindications for the magnetic resonance study, especially carriers of non-compatible pacemakers, neurostimulators, cochlear implants and intracranial aneurysm clamping.
- Patients with severe psychiatric illness or moderate or severe cognitive impairment.
- Patients who refuse to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SarcoImage: Anatomical and Physiological Validation by Magnetic Resonance Imaging Biomarkers of the Effects of High Intensity Strenght Training and Myofascial Self-conditioning on Sarcopenia in Frail and Prefrail Elderly
The aim is quantify, correlate and establish the diagnostic and prognostic value of the variation of the image biomarkers obtained by magnetic resonance (muscle volume, morphological, biochemical and structural biomarkers) longitudinally in fragile or pre-frail elders with sarcopenia after a mixed physical training of strength and myofascial self-conditioning. This project is based on an, longitudinal, prospective, controlled, randomized, intervention study and blind for the researchers responsible for the study. 60 elderly with sarcopenia and frailty (Intervention Group, n=30; Control Group, n=30) will participate in the study. Intervention Group participants will perform 6-months mixed exercise program consisting in high-intensity strength training and self-myofascial conditioning. Data will be take trough 2 measurements that will be take place at baseline and post-intervention. Criteria of frailty, criteria of sarcopenia, sociodemographic, clinics, kinanthropometric, functional, nutritional and confusing variables will be evaluated. Moreover, magnetic resonance images will be performed to obtain muscle volume, morphological, biochemical and structural biomarkers.
- Conditions
- Sarcopenia
- Being tested
- Mixed exercise program
- Keywords
- Sarcopenia, Frailty, Strength, myofascial self conditioning, image biomarkers
- Medical subject headings
- Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed exercise programOther
A progressive program of high intensity strength and myofascial conditioning will be carried out in 2 non-consecutive weekly sessions (24 weeks). Each session will include:
- Warm up on a cycle ergometer
- Strength circuit: 6 exercises will be included to strengthen different muscle groups (2 in the upper extremities, 2 in the trunk and 2 in the lower extremities). 3 sets of 10-15 repetitions until the failure. The load will be set to 70% of 1 maximal resistance.
- Self-myofascial conditioning: 10 repetitions, in the direction of the fibres of each muscle group, with different materials. 7 muscle groups will be worked (quadriceps, hamstrings, abductors, gluteus, pectoralis, full back and trapezius).
- At the end, static stretches will be performed
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | They will follow their daily routine without added exercise |
| Intervention Group | Experimental | They will perform the mixed exercise program Receives: Other: Mixed exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle volume
Changes related to macroscopic changes in muscle tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically muscle volume of the thigh by compartment - anterior, medial and posterior (in ml)
Measured: 6 months
Bone volume
Changes related to macroscopic changes in bone tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically relative volume of bone (in %)
Measured: 6 months
Relative volume of intramuscular fat
Changes related to macroscopic changes in fat tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically relative volume of intramuscular fat (in %)
Measured: 6 months
Extramuscular subcutaneous fat
Changes related to macroscopic changes in fat tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically extramuscular subcutaneous fat (in ml)
Measured: 6 months
Microscopic fat fraction
Changes related to microscopic changes in fat tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically microscopic fat fraction (in %)
Measured: 6 months
Descriptors of muscle texture
Changes related to microscopic changes in muscle tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically statistical descriptors of muscle texture: energy, entropy, contrast and homogeneity (adimensional)
Measured: 6 months
Diffusion coefficient
Changes related to microscopic changes in diffusion coefficient assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically diffusion coefficient and apparent diffusion coefficient (mm2/s)
Measured: 6 months
Secondary outcomes (15)
Body muscle mass
Changes produced by 6-month program of high intensity training and myofascial self-conditioning on body muscle mass (kg/m2) measured according to criteria of sarcopenia of European Working Group of Sarcopenia in Older People.
Measured: 6 months
Handgrip strength
Changes produced by 6-month program of high intensity training and myofascial self-conditioning on handgrip strength (kg) measured according to criteria of sarcopenia of European Working Group of Sarcopenia in Older People.
Measured: 6 months
Walking speed
Changes produced by 6-month program of high intensity training and myofascial self-conditioning on walking speed (m/s) measured according to criteria of sarcopenia of European Working Group of Sarcopenia in Older People.
Measured: 6 months
Body mass index
Changes on body mass index (measured in kg/m2) generated by 6-month program of high intensity training and myofascial self-conditioning
Measured: 6 months
Lean mass
Changes on lean impedance (measured in % by bioimpedance) generated by 6-month program of high intensity training and myofascial self-conditioning
Measured: 6 months
Fat mass
Changes on fat impedance (measured in % by bioimpedance) generated by 6-month program of high intensity training and myofascial self-conditioning
Measured: 6 months
Body perimeters
Changes on calf and thigh perimeter (measured in cm) generated by 6-month program of high intensity training and myofascial self-conditioning
Measured: 6 months
Articular range
Changes on range of joint movement of coxofemoral and knee articulation (measured in degrees) generated by 6-month program of high intensity training and myofascial self-conditioning
Measured: 6 months
Perceived pain
Changes on pain (measured by visual analogic scale, 0 to 10 points, higher values = worse outcome) generated by 6-month program of high intensity training and myofascial self-conditioning
Measured: 6 months
Activities of daily living
Changes in functionality and independence measured by Barthel Index (0 to 100 points, < 60 dependence, higher values = better outcome) produced by 6-month program of high intensity training and myofascial self-conditioning
Measured: 6 months
Functional and physical performance
Changes in functional and physical performance measured by Short Physical Performance Battery (0 to 12 points, higher score = higher function) produced by 6-month program of high intensity training and myofascial self-conditioning
Measured: 6 months
Forced spirometry
Changes in respiratory function, measured by forced spirometry parameters assessed with a spirometer, produced by 6-month program of high intensity training and myofascial self-conditioning
Measured: 6 months
Respiratory muscles strength
Changes in respiratory pressures generated in mouth by respiratory muscles (assessed with a respiratory pressure gauge) produced by 6-month program of high intensity training and myofascial self-conditioning
Measured: 6 months
Perceived quality of life
Changes produced by 6-month program of high intensity training and myofascial self-conditioning related to quality of life (EuroQol 5 Dimensions - 3 levels Index, 0 to 1 points, higher values = better outcome)
Measured: 6 months
Type of drugs used
Type and dose of drugs consumed before and after a 6-month program of high intensity training and myofascial self-conditioning
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start6 Feb 2019
- Primary completion15 Apr 2020
- Study completion2 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This project is based on an, longitudinal, prospective, controlled, randomized, intervention study and blind for the researchers responsible for the study. Thus, the subjects participating in the study will be divided into 2 groups, one of which will perform the mixed exercise program (intervention group, IG), and another that will follow their daily routine without added exercise (control group, CG). Each group will have 2 measurements in which the corresponding variables will be evaluated: A) before the start of the intervention, B) at 6 months (at the end of the intervention)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Universidad Católica de Valencia San Vicente Mártir, Quironsalud
- Responsible party
- Principal investigator, Francisco Martínez Arnau, University of Valencia
- Investigators
- Francisco Martinez Arnau, PhD, Principal investigator, Universitat de ValenciaRoberto Sanz Requena, PhD, Study director, Hospital QuironSalud - Hospital Universitario La Fe (GIBI)Ana Pablos Monzó, PhD, Study director, Fundación Universidad Católica de ValenciaPilar Pérez-Ros, PhD, Study director, Fundación Universidad Católica de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834558
- Sponsor's protocol ID
- H1488746567568
- Acronym
- SarcoImage
- Status last verified
- Nov 2020
- First submitted
- 24 Sep 2018
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared with other researchers
Publications
Flor-Rufino C, Barrachina-Igual J, Perez-Ros P, Pablos-Monzo A, Sanz-Requena R, Martinez-Arnau FM. Fat infiltration and muscle hydration improve after high-intensity resistance training in women with sarcopenia. A randomized clinical trial. Maturitas. 2023 Feb;168:29-36. doi: 10.1016/j.maturitas.2022.09.001. Epub 2022 Nov 4.
PubMed 36423489Flor-Rufino C, Barrachina-Igual J, Perez-Ros P, Pablos-Monzo A, Martinez-Arnau FM. Resistance training of peripheral muscles benefits respiratory parameters in older women with sarcopenia: Randomized controlled trial. Arch Gerontol Geriatr. 2023 Jan;104:104799. doi: 10.1016/j.archger.2022.104799. Epub 2022 Aug 29.
PubMed 36070636
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SarcoImage: Anatomical and Physiological Validation by Magnetic Resonance Imaging Biomarkers of the Effects of High Intensity Strenght Training and Myofascial Self-conditioning on Sarcopenia in Frail and Prefrail Elderly
- ClinicalTrials.gov ID
- NCT03834558
- Acronym / sponsor ID
- SarcoImage / H1488746567568
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Frailty, Strength, myofascial self conditioning, image biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Fundación Universidad Católica de Valencia San Vicente Mártir, Quironsalud
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 8 Feb 2019 (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.
The aim is quantify, correlate and establish the diagnostic and prognostic value of the variation of the image biomarkers obtained by magnetic resonance (muscle volume, morphological, biochemical and structural biomarkers) longitudinally in fragile or pre-frail elders with sarcopenia after a mixed physical training of strength and myofascial self-conditioning. This project is based on an, longitudinal, prospective, controlled, randomized, intervention study and blind for the researchers responsible for the study. 60 elderly with sarcopenia and frailty (Intervention Group, n=30; Control Group, n=30) will participate in the study. Intervention Group participants will perform 6-months mixed exercise program consisting in high-intensity strength training and self-myofascial conditioning. Data will be take trough 2 measurements that will be take place at baseline and post-intervention. Criteria of frailty, criteria of sarcopenia, sociodemographic, clinics, kinanthropometric, functional, nutritional and confusing variables will be evaluated. Moreover, magnetic resonance images will be performed to obtain muscle volume, morphological, biochemical and structural biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This project is based on an, longitudinal, prospective, controlled, randomized, intervention study and blind for the researchers responsible for the study. Thus, the subjects participating in the study will be divided into 2 groups, one of which will perform the mixed exercise program (intervention group, IG), and another that will follow their daily routine without added exercise (control group, CG). Each group will have 2 measurements in which the corresponding variables will be evaluated: A) before the start of the intervention, B) at 6 months (at the end of the intervention)
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –They will follow their daily routine without added exercise |
| Intervention Group | Experimental | Other: Mixed exercise programThey will perform the mixed exercise program |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Patients of both genders,
- aged 70 years old or more,
- with habitual residence in Valencia,
- with independent wandering (they can have technical aids, but not from someone else)
- that meets Fried's pre-frailty or frailty criteria
Key exclusion criteria (7 listed)
- Patients with life expectancy less than six months
- Institutionalized patients
- Patients with severe visual or auditory deficits
- Patients with contraindication in the performance of physical exercise (cardiovascular risk factors)
- Patients with contraindications for the magnetic resonance study, especially carriers of non-compatible pacemakers, neurostimulators, cochlear implants and intracranial aneurysm clamping.
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 |
|---|---|---|
| Mixed exercise programA progressive program of high intensity strength and myofascial conditioning will be carried out in 2 non-consecutive weekly sessions (24 weeks). Each session will include: A) Warm up on a cycle ergometer B) Strength circuit: 6 exercises will be included to strengthen different muscle groups (2 in the upper extremities, 2 in the trunk and 2 in the lower extremities). 3 sets of 10-15 repetitions until the failure. The load will be set to 70% of 1 maximal resistance. C) Self-myofascial conditioning: 10 repetitions, in the direction of the fibres of each muscle group, with different materials. 7 muscle groups will be worked (quadriceps, hamstrings, abductors, gluteus, pectoralis, full back and trapezius). D) At the end, static stretches will be performed | Other | Intervention Group |
Primary outcome
Muscle volume
Time frame: 6 months
Changes related to macroscopic changes in muscle tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically muscle volume of the thigh by compartment - anterior, medial and posterior (in ml)
Bone volume
Time frame: 6 months
Changes related to macroscopic changes in bone tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically relative volume of bone (in %)
Relative volume of intramuscular fat
Time frame: 6 months
Changes related to macroscopic changes in fat tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically relative volume of intramuscular fat (in %)
Extramuscular subcutaneous fat
Time frame: 6 months
Changes related to macroscopic changes in fat tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically extramuscular subcutaneous fat (in ml)
Microscopic fat fraction
Time frame: 6 months
Changes related to microscopic changes in fat tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically microscopic fat fraction (in %)
Descriptors of muscle texture
Time frame: 6 months
Changes related to microscopic changes in muscle tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically statistical descriptors of muscle texture: energy, entropy, contrast and homogeneity (adimensional)
Diffusion coefficient
Time frame: 6 months
Changes related to microscopic changes in diffusion coefficient assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically diffusion coefficient and apparent diffusion coefficient (mm2/s)
15 secondary outcomes
Body muscle mass
Time frame: 6 months
Handgrip strength
Time frame: 6 months
Walking speed
Time frame: 6 months
Body mass index
Time frame: 6 months
Lean mass
Time frame: 6 months
Fat mass
Time frame: 6 months
Body perimeters
Time frame: 6 months
Articular range
Time frame: 6 months
Perceived pain
Time frame: 6 months
Activities of daily living
Time frame: 6 months
Functional and physical performance
Time frame: 6 months
Forced spirometry
Time frame: 6 months
Respiratory muscles strength
Time frame: 6 months
Perceived quality of life
Time frame: 6 months
Type of drugs used
Time frame: 6 months
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 3 Nov 2020.
- Derived from this study: PubMed 36423489Flor-Rufino C, Barrachina-Igual J, Perez-Ros P, Pablos-Monzo A, Sanz-Requena R, Martinez-Arnau FM. Fat infiltration and muscle hydration improve after high-intensity resistance training in women with sarcopenia. A randomized clinical trial. Maturitas. 2023 Feb;168:29-36. doi: 10.1016/j.maturitas.2022.09.001. Epub 2022 Nov 4.
- Derived from this study: PubMed 36070636Flor-Rufino C, Barrachina-Igual J, Perez-Ros P, Pablos-Monzo A, Martinez-Arnau FM. Resistance training of peripheral muscles benefits respiratory parameters in older women with sarcopenia: Randomized controlled trial. Arch Gerontol Geriatr. 2023 Jan;104:104799. doi: 10.1016/j.archger.2022.104799. Epub 2022 Aug 29.
- Individual participant dataSharing planned: No. No data will be shared with other researchers
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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.
Francisco Martinez Arnau, PhD principal investigator
Universitat de Valencia
Roberto Sanz Requena, PhD study director
Hospital QuironSalud - Hospital Universitario La Fe (GIBI)
Ana Pablos Monzó, PhD study director
Fundación Universidad Católica de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed exercise program in people with Sarcopenia, run by University of Valencia 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 7 inclusion and 7 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 3 Nov 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?
Muscle volume (time frame: 6 months). The study lists 7 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 NCT03834558, which also lists 2 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 3 Nov 2020.