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Imaging Biomarkers of the Effects of a Mixed Exercise Program

NCT ID: NCT03834558

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-06

Study Completion Date

2020-11-02

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigator: The persons who make the data analysis and decide whether a patient has experienced an outcome of interest will be masked.

Outcome assessors: The persons who assess patients and provide outcome data will be masked.

Study Groups

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Control Group

They will follow their daily routine without added exercise

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

They will perform the mixed exercise program

Group Type EXPERIMENTAL

Mixed exercise program

Intervention Type OTHER

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:

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

Interventions

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Mixed exercise program

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:

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Universidad Católica de Valencia San Vicente Mártir

OTHER

Sponsor Role collaborator

Quironsalud

OTHER

Sponsor Role collaborator

University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Francisco Martínez Arnau

Martínez-Arnau FM, PT, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco Martinez Arnau, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat de Valencia

Roberto Sanz Requena, PhD

Role: STUDY_DIRECTOR

Hospital QuironSalud - Hospital Universitario La Fe (GIBI)

Ana Pablos Monzó, PhD

Role: STUDY_DIRECTOR

Fundación Universidad Católica de Valencia

Pilar Pérez-Ros, PhD

Role: STUDY_DIRECTOR

Fundación Universidad Católica de Valencia

Locations

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University of Valencia - Faculty of Physiotherapy

Valencia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 36423489 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36070636 (View on PubMed)

Other Identifiers

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H1488746567568

Identifier Type: -

Identifier Source: org_study_id