Imaging Biomarkers of the Effects of a Mixed Exercise Program (SarcoImage)
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mixed exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia focused on measuring Sarcopenia, Frailty, Strength, myofascial self conditioning, image biomarkers
Eligibility Criteria
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.
Sites / Locations
- University of Valencia - Faculty of Physiotherapy
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Intervention Group
Arm Description
They will follow their daily routine without added exercise
They will perform the mixed exercise program
Outcomes
Primary Outcome Measures
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)
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 %)
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 %)
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)
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 %)
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)
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)
Secondary Outcome Measures
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.
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.
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.
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
Lean mass
Changes on lean impedance (measured in % by bioimpedance) generated by 6-month program of high intensity training and myofascial self-conditioning
Fat mass
Changes on fat impedance (measured in % by bioimpedance) generated by 6-month program of high intensity training and myofascial self-conditioning
Body perimeters
Changes on calf and thigh perimeter (measured in cm) generated by 6-month program of high intensity training and myofascial self-conditioning
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
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
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
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
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
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
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)
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
Full Information
NCT ID
NCT03834558
First Posted
September 24, 2018
Last Updated
November 2, 2020
Sponsor
University of Valencia
Collaborators
Fundación Universidad Católica de Valencia San Vicente Mártir, Quironsalud
1. Study Identification
Unique Protocol Identification Number
NCT03834558
Brief Title
Imaging Biomarkers of the Effects of a Mixed Exercise Program
Acronym
SarcoImage
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
November 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
Fundación Universidad Católica de Valencia San Vicente Mártir, Quironsalud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Sarcopenia, Frailty, Strength, myofascial self conditioning, image biomarkers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
They will follow their daily routine without added exercise
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
They will perform the mixed exercise program
Intervention Type
Other
Intervention Name(s)
Mixed exercise program
Intervention 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:
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
Primary Outcome Measure Information:
Title
Muscle volume
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)
Time Frame
6 months
Title
Bone volume
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 %)
Time Frame
6 months
Title
Relative volume of intramuscular fat
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 %)
Time Frame
6 months
Title
Extramuscular subcutaneous fat
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)
Time Frame
6 months
Title
Microscopic fat fraction
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 %)
Time Frame
6 months
Title
Descriptors of muscle texture
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)
Time Frame
6 months
Title
Diffusion coefficient
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Body muscle mass
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.
Time Frame
6 months
Title
Handgrip strength
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.
Time Frame
6 months
Title
Walking speed
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.
Time Frame
6 months
Title
Body mass index
Description
Changes on body mass index (measured in kg/m2) generated by 6-month program of high intensity training and myofascial self-conditioning
Time Frame
6 months
Title
Lean mass
Description
Changes on lean impedance (measured in % by bioimpedance) generated by 6-month program of high intensity training and myofascial self-conditioning
Time Frame
6 months
Title
Fat mass
Description
Changes on fat impedance (measured in % by bioimpedance) generated by 6-month program of high intensity training and myofascial self-conditioning
Time Frame
6 months
Title
Body perimeters
Description
Changes on calf and thigh perimeter (measured in cm) generated by 6-month program of high intensity training and myofascial self-conditioning
Time Frame
6 months
Title
Articular range
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
Time Frame
6 months
Title
Perceived pain
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
Time Frame
6 months
Title
Activities of daily living
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
Time Frame
6 months
Title
Functional and physical performance
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
Time Frame
6 months
Title
Forced spirometry
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
Time Frame
6 months
Title
Respiratory muscles strength
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
Time Frame
6 months
Title
Perceived quality of life
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)
Time Frame
6 months
Title
Type of drugs used
Description
Type and dose of drugs consumed before and after a 6-month program of high intensity training and myofascial self-conditioning
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Martinez Arnau, PhD
Organizational Affiliation
Universitat de Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto Sanz Requena, PhD
Organizational Affiliation
Hospital QuironSalud - Hospital Universitario La Fe (GIBI)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ana Pablos Monzó, PhD
Organizational Affiliation
Fundación Universidad Católica de Valencia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pilar Pérez-Ros, PhD
Organizational Affiliation
Fundación Universidad Católica de Valencia
Official's Role
Study Director
Facility Information:
Facility Name
University of Valencia - Faculty of Physiotherapy
City
Valencia
ZIP/Postal Code
46009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data will be shared with other researchers
Citations:
PubMed Identifier
36070636
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.
Results Reference
derived
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Imaging Biomarkers of the Effects of a Mixed Exercise Program
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