Improving Rehabilitation In Sarcopenia (IRIS)

NCT03120026 | Completed

• 1 other identifier: 20170011726
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from sarcopenia

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Gait speed

  Change in gait speed (4-meter walking test)/month

  8 weeks

Secondary Outcomes (13)

• Physical performance - Tinetti

  8 weeks

• Physical performance - Timed Up and Go test

  8 weeks

• Physical performance - chair-stand

  8 weeks

• Functional status - Barthel

  8 weeks

• Functional status - ADL

  8 weeks

Other Outcomes (2)

• Intensity of care

  8 weeks

• Type of discharge

  8 weeks

Study Arms (2)

Experimental Product

EXPERIMENTAL

Two servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.

Dietary Supplement: Experimental product

Isocaloric Placebo

PLACEBO COMPARATOR

Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water.

Dietary Supplement: Isocaloric placebo

Interventions

Experimental product DIETARY_SUPPLEMENT

Two servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.

Experimental Product

Isocaloric placebo DIETARY_SUPPLEMENT

Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water.

Isocaloric Placebo

Eligibility Criteria

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

You may qualify if:

• age 65 years or older
• admission for physical rehabilitation
• sarcopenia, measured with bioelectrical impedance assessment (BIA) + handgrip strength and gait speed
• Mini Mental State Examination ≥18
• Informed consent

You may not qualify if:

• Any malignant disease during the last five years
• Known kidney failure (previous glomerular filtration rate \<30 ml/min);
• Known liver failure (Child B or C)
• Psychiatric disease
• Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
• Indications related to the study product:
• More than 10 µg (400 IU) of daily Vitamin D intake from medical sources More than 500 mg of daily calcium intake from medical sources. Adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study.
• Known allergy to milk, milk products or other components of the proposed interventions
• Indication to or ongoing artificial nutrition support
• Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
• Refusal

Sponsors & Collaborators

• Azienda di Servizi alla Persona di Pavia: lead

Study Sites (2)

Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia

Pavia, 27100, Italy

Location

Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita, Azienda di Servizi alla Persona di Pavia

Pavia, 27100, Italy

Location

Related Publications (1)

• Rondanelli M, Cereda E, Klersy C, Faliva MA, Peroni G, Nichetti M, Gasparri C, Iannello G, Spadaccini D, Infantino V, Caccialanza R, Perna S. Improving rehabilitation in sarcopenia: a randomized-controlled trial utilizing a muscle-targeted food for special medical purposes. J Cachexia Sarcopenia Muscle. 2020 Dec;11(6):1535-1547. doi: 10.1002/jcsm.12532. Epub 2020 Sep 22.

  PMID: 32961041 DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

• Mariangela Rondanelli, MD, PhD

  Azienda di Servizi alla Persona di Pavia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 19, 2017
• Study Start: May 10, 2017
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

IT (2)