Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-28 @ 10:01 PM
Study NCT ID:
NCT03834558
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2018-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging Biomarkers of the Effects of a Mixed Exercise Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigator: The persons who make the data analysis and decide whether a patient has experienced an outcome of interest will be masked.\n\nOutcome assessors: The persons who assess patients and provide outcome data will be masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).\n\nEach 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)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2018-09-24', 'studyFirstSubmitQcDate': '2019-02-05', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle volume', 'timeFrame': '6 months', 'description': '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)'}, {'measure': 'Bone volume', 'timeFrame': '6 months', 'description': '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 %)'}, {'measure': 'Relative volume of intramuscular fat', 'timeFrame': '6 months', 'description': '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 %)'}, {'measure': 'Extramuscular subcutaneous fat', 'timeFrame': '6 months', 'description': '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)'}, {'measure': 'Microscopic fat fraction', 'timeFrame': '6 months', 'description': '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 %)'}, {'measure': 'Descriptors of muscle texture', 'timeFrame': '6 months', 'description': '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)'}, {'measure': 'Diffusion coefficient', 'timeFrame': '6 months', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Body muscle mass', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Handgrip strength', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Walking speed', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Body mass index', 'timeFrame': '6 months', 'description': 'Changes on body mass index (measured in kg/m2) generated by 6-month program of high intensity training and myofascial self-conditioning'}, {'measure': 'Lean mass', 'timeFrame': '6 months', 'description': 'Changes on lean impedance (measured in % by bioimpedance) generated by 6-month program of high intensity training and myofascial self-conditioning'}, {'measure': 'Fat mass', 'timeFrame': '6 months', 'description': 'Changes on fat impedance (measured in % by bioimpedance) generated by 6-month program of high intensity training and myofascial self-conditioning'}, {'measure': 'Body perimeters', 'timeFrame': '6 months', 'description': 'Changes on calf and thigh perimeter (measured in cm) generated by 6-month program of high intensity training and myofascial self-conditioning'}, {'measure': 'Articular range', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Perceived pain', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Activities of daily living', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Functional and physical performance', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Forced spirometry', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Respiratory muscles strength', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Perceived quality of life', 'timeFrame': '6 months', 'description': '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)'}, {'measure': 'Type of drugs used', 'timeFrame': '6 months', 'description': 'Type and dose of drugs consumed before and after a 6-month program of high intensity training and myofascial self-conditioning'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcopenia', 'Frailty', 'Strength', 'myofascial self conditioning', 'image biomarkers'], 'conditions': ['Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '36423489', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '36070636', 'type': 'DERIVED', 'citation': 'Flor-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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients of both genders,\n* aged 70 years old or more,\n* with habitual residence in Valencia,\n* with independent wandering (they can have technical aids, but not from someone else)\n* that meets Fried's pre-frailty or frailty criteria\n* EGWSOP's sarcopenia criteria\n* who has agreed to participate in the study and signed the informed consent\n\nExclusion Criteria:\n\n* Patients with life expectancy less than six months\n* Institutionalized patients\n* Patients with severe visual or auditory deficits\n* Patients with contraindication in the performance of physical exercise (cardiovascular risk factors)\n* Patients with contraindications for the magnetic resonance study, especially carriers of non-compatible pacemakers, neurostimulators, cochlear implants and intracranial aneurysm clamping.\n* Patients with severe psychiatric illness or moderate or severe cognitive impairment.\n* Patients who refuse to sign the informed consent."}, 'identificationModule': {'nctId': 'NCT03834558', 'acronym': 'SarcoImage', 'briefTitle': 'Imaging Biomarkers of the Effects of a Mixed Exercise Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'H1488746567568'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'They will follow their daily routine without added exercise'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'They will perform the mixed exercise program', 'interventionNames': ['Other: Mixed exercise program']}], 'interventions': [{'name': 'Mixed exercise program', 'type': 'OTHER', 'description': '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:\n\nA) Warm up on a cycle ergometer\n\nB) 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.\n\nC) 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).\n\nD) At the end, static stretches will be performed', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'University of Valencia - Faculty of Physiotherapy', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Francisco Martinez Arnau, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitat de Valencia'}, {'name': 'Roberto Sanz Requena, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital QuironSalud - Hospital Universitario La Fe (GIBI)'}, {'name': 'Ana Pablos Monzó, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundación Universidad Católica de Valencia'}, {'name': 'Pilar Pérez-Ros, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundación Universidad Católica de Valencia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data will be shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valencia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundación Universidad Católica de Valencia San Vicente Mártir', 'class': 'OTHER'}, {'name': 'Quironsalud', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Martínez-Arnau FM, PT, PhD', 'investigatorFullName': 'Francisco Martínez Arnau', 'investigatorAffiliation': 'University of Valencia'}}}}