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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01829009
• Other study ID #: GER-887-13/14-1
• Status: Withdrawn
• Phase: N/A
• First received: April 2, 2013
• Last updated: April 20, 2015

Study information

• Verified date: April 2015
• Source: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Study withdrawn.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
Mexico	National Institue of Medical Sciences and Nutrition Salvador Zubirán	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rosenberg IH. Sarcopenia: origins and clinical relevance. J Nutr. 1997 May;127(5 Suppl):990S-991S. Review. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in gait speed and functional status in sarcopenic older women		improvement in gait speed and functional status in sarcopenic older women in weeks 6,12 and 24	No
Secondary	Increase in muscle mass in sarcopenic older women		Increase in muscle mass in sarcopenic older women in week 24	No