Physical Activity Program for Counteracting Sarcopenia

NCT04172285 | Unknown

• 1 other identifier: EXERSARCO
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Lower limb strength

  Assessed by chair stand test

  Baseline and Week 24

Secondary Outcomes (5)

• Body composition

  Baseline and Week 24

• Quantify thigh cross sectional area

  Baseline and Week 24

• Maximum isometric force that a hand can squeeze

  Baseline and Week 24

• Maximal Isometric Strength of Knee flexors and extensors

  Baseline AND Week 24

• Dynamic balance and gait deficits

  Baseline and Week 24

Study Arms (3)

Physical activity group

EXPERIMENTAL

Behavioral: Physical activity

Physical activity and supplementation group

EXPERIMENTAL

Dietary Supplement: Physical activity and supplementation

Control group

EXPERIMENTAL

Other: Control

Interventions

Physical activity BEHAVIORAL

Home-based physical activity program

Physical activity group

Physical activity and supplementation DIETARY_SUPPLEMENT

Home-based physical activity program and amminoacid supplementation

Physical activity and supplementation group

Control OTHER

No intervention

Control group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sedentary lifestyle.
• Cognitively intact.
• Autonomous walking.
• Acceptance of informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20141, Italy

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Exercise; Dietary Supplements

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 21, 2019
• Study Start: September 18, 2019
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

IT (1)