Resistance Exercise Effect on Physical Performance and Functional Status in Sarcopenic Older Women

• ClinicalTrials.gov Identifier: NCT01829009
• Recruitment Status: Withdrawn
• First Posted: April 11, 2013
• Last Update Posted: April 22, 2015
• Sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
• Information provided by (Responsible Party): José Alberto Ávila Funes, National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Study Description

Brief Summary:

Aging is characterized by a progressive loss of multiple physical and cognitive abilities. From these changes, the most important one is the loss of muscle mass, which has been called "sarcopenia". Resistance exercise is a therapeutic approach for sarcopenia, nevertheless there is no universal consensus. Therefore, this research is interested in determining the effect of a resistance exercise program on physical performance and/or functional status in sarcopenic older women. The main study hypothesis is that a program of resistance exercise will improve physical performance and functional status in sarcopenic older women compared against general recommendations.

This is a single-blind, controlled clinical trial, including women> 70 years, living in the community with sarcopenia. Those who agree to participate, will be randomly assigned to one of the following groups:

1. Resistance Exercise Group
2. General Recommendations Group (control) The study will last 24 weeks, with 4 measurements performed at baseline, week 6, 12 and 24. Multilevel models (random effects) will be constructed for the comparison between the two groups. Tests will be conducted with a P=0.05 and confidence intervals at 95%. This protocol has been approved by the local ethics committee.

Condition or disease	Intervention/treatment	Phase
Sarcopenia	Other: Resistance Exercise Group	Not Applicable

Detailed Description:

Study withdrawn.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Resistance Exercise Effect on Physical Performance and Functional Status in Sarcopenic Older Women
• Actual Primary Completion Date: April 2013

Arms and Interventions

Arm	Intervention/treatment
No Intervention: General Recommendations Group; General information about sarcopenia will be provided to the participants, as well as general recommendations of healthy habits. We will contact the participants weekly by phone to answer questions about sarcopenia, and remind them of their next appointment and about adverse events occured during this period of time. The frequent contact with the participants has also the purpose to prevent losses or rejections for future evaluations
Experimental: Resistance Exercise Group; An individualized resistance exercise program wil be applied twice a week by an expert physiotherapist. Every 2 weeks, intensity will be reassessed by the same physiotherapist. Weekly, participants will be asked about incidents such as the occurrence of falls or hospitalizations during this study period. Physical performance and functional status will be assessed by the blind investigator at weeks 6,12 and 24	Other: Resistance Exercise Group; An individualized resistance exercise program wil be applied twice a week by an expert physiotherapist. Every 2 weeks, intensity will be reassessed by the same physiotherapist. Weekly, participants will be asked about incidents such as the occurrence of falls or hospitalizations during this study period. Physical performance and functional status will be assessed by the blind investigator at weeks 6,12 and 24

Outcome Measures

Primary Outcome Measures :

1. Improvement in gait speed and functional status in sarcopenic older women [ Time Frame: improvement in gait speed and functional status in sarcopenic older women in weeks 6,12 and 24 ]

Secondary Outcome Measures :

1. Increase in muscle mass in sarcopenic older women [ Time Frame: Increase in muscle mass in sarcopenic older women in week 24 ]

Eligibility Criteria

• Ages Eligible for Study: 70 Years and older (Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Body mass composition by BIA with skeletal muscle mass <6.76kg/m2
• Speed gait of <0.8m/sec
• Handgrip strength (adjusted for BMI) less than 20kg

Exclusion Criteria:

• Current diagnosis of malnutrition (BMI <19kg/m2)
• Decompensated heart failure (NYHA III or IV)
• Hemiplegia or hemiparesis due to cerebral vascular disease
• Exacerbation of chronic obstructive pulmonary disease
• Dementia (any type, moderate or severe stage)
• Uncontrolled diabetes mellitus (glycosylated hemoglobin >8%)
• Severe pain in hips, knees or ankles
• Fracture of lower limb in the last 6 months
• Myocardial infarction within the past 6 months
• Severe hypertension (SBP > 180mmHg or DBP > 110 mmHg)
• Orthostatic hypotension

Contacts and Locations

Locations

Mexico

National Institue of Medical Sciences and Nutrition Salvador Zubirán

Mexico City, Mexico, 14000

Sponsors and Collaborators

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Investigators

• Principal Investigator: JOSE ALBERTO AVILA FUNES, MD PhD; GERIATRICS CHIEF DEPARTMENT

More Information

Publications:

Rosenberg IH. Sarcopenia: origins and clinical relevance. J Nutr. 1997 May;127(5 Suppl):990S-991S. doi: 10.1093/jn/127.5.990S. Review.

Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinková E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

Yarasheski KE, Zachwieja JJ, Bier DM. Acute effects of resistance exercise on muscle protein synthesis rate in young and elderly men and women. Am J Physiol. 1993 Aug;265(2 Pt 1):E210-4. Erratum in: Am J Physiol 1993 Oct;265(4 Pt 1):followi. Am J Physiol Endocrinol Metab. 1993 Oct 1;265(1):1a.

Baumgartner RN, Koehler KM, Gallagher D, Romero L, Heymsfield SB, Ross RR, Garry PJ, Lindeman RD. Epidemiology of sarcopenia among the elderly in New Mexico. Am J Epidemiol. 1998 Apr 15;147(8):755-63. Erratum in: Am J Epidemiol 1999 Jun 15;149(12):1161.

Visser M, Kritchevsky SB, Goodpaster BH, Newman AB, Nevitt M, Stamm E, Harris TB. Leg muscle mass and composition in relation to lower extremity performance in men and women aged 70 to 79: the health, aging and body composition study. J Am Geriatr Soc. 2002 May;50(5):897-904.

Visser M, Harris TB, Langlois J, Hannan MT, Roubenoff R, Felson DT, Wilson PW, Kiel DP. Body fat and skeletal muscle mass in relation to physical disability in very old men and women of the Framingham Heart Study. J Gerontol A Biol Sci Med Sci. 1998 May;53(3):M214-21.

Janssen I, Heymsfield SB, Baumgartner RN, Ross R. Estimation of skeletal muscle mass by bioelectrical impedance analysis. J Appl Physiol (1985). 2000 Aug;89(2):465-71.

Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96.

Kim HK, Suzuki T, Saito K, Yoshida H, Kobayashi H, Kato H, Katayama M. Effects of exercise and amino acid supplementation on body composition and physical function in community-dwelling elderly Japanese sarcopenic women: a randomized controlled trial. J Am Geriatr Soc. 2012 Jan;60(1):16-23. doi: 10.1111/j.1532-5415.2011.03776.x. Epub 2011 Dec 5. Erratum in: J Am Geriatr Soc. 2012 Mar;60(3):605.

Velazquez MC, Irigoyen ME. Sarcopenia: Una entidad de relevancia clínica actual. Rev Cien Clin 2011;12(1):22-33

Latham NK, Bennett DA, Stretton CM, Anderson CS. Systematic review of progressive resistance strength training in older adults. J Gerontol A Biol Sci Med Sci. 2004 Jan;59(1):48-61. Review.

• Responsible Party: José Alberto Ávila Funes, PhD, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
• ClinicalTrials.gov Identifier: NCT01829009
• Other Study ID Numbers: GER-887-13/14-1
• First Posted: April 11, 2013
• Last Update Posted: April 22, 2015
• Last Verified: April 2015

Keywords provided by José Alberto Ávila Funes, National Institute of Medical Sciences and Nutrition, Salvador Zubiran:

Sarcopenia; Elderly; Women; Resistance; Exercise

Additional relevant MeSH terms:

Sarcopenia; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical