Imaging Biomarkers of the Effects of a Mixed Exercise Program

NCT03834558 | Completed

• 1 other identifier: H1488746567568
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Sarcopenia; Frailty; Strength; myofascial self conditioning; image biomarkers

Outcome Measures

Primary Outcomes (7)

• 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)

  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 %)

  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 %)

  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)

  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 %)

  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)

  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)

  6 months

Secondary Outcomes (15)

• Body muscle mass

  6 months

• Handgrip strength

  6 months

• Walking speed

  6 months

• Body mass index

  6 months

• Lean mass

  6 months

Study Arms (2)

Control Group

NO INTERVENTION

They will follow their daily routine without added exercise

Intervention Group

EXPERIMENTAL

They will perform the mixed exercise program

Other: Mixed exercise program

Interventions

Mixed exercise program 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

Intervention Group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead
• Fundación Universidad Católica de Valencia San Vicente Mártir: collaborator
• Quironsalud: collaborator

Study Sites (1)

University of Valencia - Faculty of Physiotherapy

Valencia, 46009, Spain

Location

Related Publications (2)

• 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: 36423489 DERIVED

• 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.

  PMID: 36070636 DERIVED

MeSH Terms

Conditions

Sarcopenia; Frailty

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Officials

• Francisco Martinez Arnau, PhD

  Universitat de Valencia

  PRINCIPAL INVESTIGATOR

• Roberto Sanz Requena, PhD

  Hospital QuironSalud - Hospital Universitario La Fe (GIBI)

  STUDY DIRECTOR

• Ana Pablos Monzó, PhD

  Fundación Universidad Católica de Valencia

  STUDY DIRECTOR

• Pilar Pérez-Ros, PhD

  Fundación Universidad Católica de Valencia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Martínez-Arnau FM, PT, PhD

Model Details: 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)

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: February 8, 2019
• Study Start: February 6, 2019
• Primary Completion: April 15, 2020
• Study Completion: November 2, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)