Combined Effects of Resistance Training and Nutritional Supplements in the Treatment of Sarcopenia

NCT00748696 | Terminated Phase 3

• 1 other identifier: 06-API-04
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Age-related sarcopenia is associated with increased morbidity, mortality, disability and reduced resistance to metabolic stress. The aim of this study is to assess the effects of resistance training, associated or not with oral nutritional supplements, on skeletal muscle mass in sarcopenic subjects. This is a prospective randomised controlled single-centre study that will last two years, three months for a participant. 200 healthy elderly (70-80 years old) subjects will be screened for sarcopenia by dual energy X-ray absorptiometry. 128 sarcopenic subjects will be randomized into 4 groups:

• group 1: controls
• group 2: oral nutritional supplement (260 kcal and 20 g protein per day)
• group 3: resistance training (3 times per week)
• group 4: oral nutritional supplement + resistance training Every subject will be assessed at the beginning and at the end of 12 weeks of intervention on:
• muscle mass (DXA)
• muscle function (dynamometers)
• hormonal (testosterone, GH, IGF-1, cortisol) and inflammatory (IL-6, TNF-alpha) profiles
• food intake. Ten subjects in group 4 will undergo a muscle biopsy (quadriceps) before and after the intervention in order to explore protein and mRNA levels of the mTOR pathway, which may be involved in sarcopenia.

Conditions

Sarcopenia

Keywords

sarcopenia; elderly; resistance training; oral nutritional supplement

Outcome Measures

Primary Outcomes (1)

• muscle mass (DXA)

  D0 and after 12 weeks

Secondary Outcomes (1)

• muscle function (dynamometers), hormonal (testosterone, GH, IGF-1, cortisol) and inflammatory (IL-6, TNF-alpha) profiles, food intake, ± muscle biopsy.

  D0 and after 12 weeks

Study Arms (4)

1

NO INTERVENTION

No intervention

2

EXPERIMENTAL

patient receiving oral nutrition supplement

Dietary Supplement: Fortimel Extra®

3

EXPERIMENTAL

resistance training

Other: resistance training

4

EXPERIMENTAL

patients receiving resistance training and oral nutritional supplement

Other: combined treatment

Interventions

Fortimel Extra® DIETARY_SUPPLEMENT

260kcal and 20g protein per day

2

resistance training OTHER

3 sessions of resistance training per week

3

combined treatment OTHER

260kcal and 20g protein per day 3 sessions of resistance training per week

4

Eligibility Criteria

• Age: 70 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age between 70 and 80 years
• Stable weight (± 1 kg) during the last three months
• Informed consent signed
• Chronic cachectic condition: cancer, chronic respiratory failure, advanced organ failure, hyperthyroidism, rheumatoid arthritis, AIDS, type 1 diabetes
• Drugs affecting muscle mass (e.g. steroids)
• Condition (clinical or EKG) significantly affecting physical capacities and/or contra-indicating resistance training
• Habitual practice of resistance training
• Habitual intake of nutritional supplements
• Known coagulation disorders (for muscle biopsy)
• Known allergy to lidocaine (for muscle biopsy)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Department of gastroenterology, Department of Gerontology

Nice, 06000, France

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Resistance Training; Combined Modality Therapy

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)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stephane Schneider, PU PH

  Department of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 8, 2008
• Study Start: December 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 22, 2012

Record last verified: 2009-06

Locations

FR (1)