Physical Activity Program for Counteracting Sarcopenia

Sarcopenia Clinical Trial

— EXERSARCO  

Official title:

Effects of an Home-base Physical Activity Program for Counteracting Sarcopenia in Elderly: a Randomized-controlled Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04172285
• Other study ID #: EXERSARCO
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: December 20, 2021

Study information

• Verified date: February 2021
• Source: Istituto Ortopedico Galeazzi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sarcopenia is a pathophysiological process associated with aging and some metabolic conditions characterized by progressive muscle tissue loss, which may lead to loss of strangth and performance and increase risk of falls and fractures, physical disability and premature death. Therefore, it is necessary to identify personalized programs of physical activity and supplementation for elderly population in order to improve their physical functions, muscle strengh and body composition.

With the present project we aime to assess the effect of a feasible home-based exercise program coupled with food supplementation to improve muscle strength, muscle volume and muscle physical performance potentially associated with sarcopenia in elderly people.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• Sedentary lifestyle.

• Cognitively intact.

• Autonomous walking.

• Acceptance of informed consent.

Exclusion Criteria:

• Body mass index lower than 18.5 and uppen than 40 kg/m2.

• History of cancer.

• Pacemaker user.

• History of epileptic episodes.

• Endocrine-metabolic, neurological, muscular and ortopedic pathologies that affect movement functions.

• Bone fractures that influence movement functions.

• Smoking.

• Surgical treatments in the prior 6 months.

• Use of antieptilectics, glucocorticoids, rhGH and testosterone.

• Hepatic and muscular pathologies

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Behavioral:
• Physical activity
Home-based physical activity program

Dietary Supplement:
• Physical activity and supplementation
Home-based physical activity program and amminoacid supplementation

Other:
• Control
No intervention

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Galeazzi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower limb strength	Assessed by chair stand test	Baseline and Week 24
Secondary	Body composition	Assessed by Whole-body dual energy X-ray absorptiometry	Baseline and Week 24
Secondary	Quantify thigh cross sectional area	Assessed by Dixon magnetic resonance imaging	Baseline and Week 24
Secondary	Maximum isometric force that a hand can squeeze	Assessed by Hand Grip Strength test	Baseline and Week 24
Secondary	Maximal Isometric Strength of Knee flexors and extensors	Assessed by a belt-stabilized dynamometer	Baseline AND Week 24
Secondary	Dynamic balance and gait deficits	Assessed by mini-BESTest	Baseline and Week 24