Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05938205 |
Other study ID # |
1956CESC |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2019 |
Est. completion date |
July 6, 2022 |
Study information
Verified date |
July 2023 |
Source |
Azienda Ospedaliera Universitaria Integrata Verona |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The study will be conducted in a group of obese sarcopenic patients (Sarco-Ob) aged > 60
years on moderately hypocaloric diet therapy aimed at comparing the effect of a strength
exercise protocol, combined or not with dietary supplementation with amino acids, on physical
performance, muscle strength, body composition, muscle oxidative metabolism, and biomarkers
of sarcopenia. The supplementation study will be conducted in a double-blind manner.
Description:
In this double-blind randomised control trial, older men, and women resident in Verona
(Italy) will be selected from the Geriatrics Nutritional Clinic of the Borgo Trento Hospital
or were contacted by telephone. A specific medical screening was initially programmed to
verify the criteria of recruitment.
Anthropometric and body composition In the morning, in a fasted state, body mass will be
taken with an electronic scale (Tanita electronic scale BWB-800 MA) and stature will be
measured with a Harpenden stadiometer (Holtain Ltd., Crymych, Pembs. UK); BMI will be
calculated as weight (kg)/height (m)2. Thereafter, total and regional body composition will
be evaluated by means of dual-energy X-ray absorptiometry (DXA) using a total body scanner
(QDR Horizon W, Hologic, MA, USA; fan-bean technology, software for Windows XP version
12.4.2) according to the manufacturer's procedures. Furthermore, the ALMI will be calculated
as the sum of lean mass of arms and legs divided by height squared.
Physical performance On the same day, the SPPB test will be used to assess functional
performance of the lower extremities. Each participant will performed: 4 m at usual customary
gait speed, a five repeated chair-stands test and three standing balance tests (side by side,
semi-tandem and tandem).
A digital dynamometer (CAMRY, Digital Hand Dynamometer model: EH101) will be used to assess
HGS and all measurements were conducted by the same operator. Before starting, participants
will observe a demonstration of the test procedure and engage in two practice attempts.
Knee muscle strength measurements and analysis An isokinetic dynamometer (CMSi Cybex Humac
Norm Dynamometer, Lumex, Ronkokoma, NY, USA) will be used to assess the isokinetic strength
of knee flexors and extensors muscles.
Maximal isokinetic knee extension-flexion tests will be performed in a randomised sequence at
60, 90, 150, 180 and 210°ˑs-1. Trials will consist in three knee extension-flexion movements
with 60 s-recovery. The maximal strength of knee extensors muscle will be calculated with the
Hill's hyperbolic function. The isokinetic knee extension-flexion power will be calculated as
the product between strength and velocity. Finally, for knee extensors, maximal muscle power
expressed in Watt, will be calculated from the power-velocity curve.
1-RM assessment Before starting training intervention, participants will perform three
sessions of familiarization with the resistance isotonic machines. High intensity strength
exercise (Exe-H) protocol: All the participants will performed a supervised progressive
resistance training protocol, three times per week, 1 hour per session. Each participant will
performed the same strength training protocol, starting with 3 sets of 8-10 repetitions at
70% of 1-RM (month 1), with a progressive increase of intensity at 75% of 1-RM (month 2 and
month 3), and 80% 1-RM that will be maintained for the rest period of intervention. The
compliance will be define as the number of exercise sessions expressed in % of the target
value. Each participant will must reach a compliance above the 70% to be included in the
final analysis.