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WithdrawnNCT01829009Updated Apr 22, 2015

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

An interventional study of Resistance Exercise Group in Sarcopenia, sponsored by National Institute of Medical Sciences and Nutrition, Salvador Zubiran. Withdrawn at 1 site in Mexico. Open to female participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2015-04-22.

Sponsored by National Institute of Medical Sciences and Nutrition, Salvador Zubiran · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Financial issues
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
70 Years and older
Sex
Female
01

Study 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.
Read the detailed description

Study withdrawn.

02

Conditions studied

  • Sarcopenia

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Keywords

  • Sarcopenia
  • Elderly
  • Women
  • Resistance
  • Exercise
03

In context

Sarcopenia

1,206 studies on the registry are indexed under Sarcopenia; 401 are open to participants now.

Browse Sarcopenia studies →

Lead sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • OtherResistance 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

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Increase in muscle mass in sarcopenic older women

    Time frame: Increase in muscle mass in sarcopenic older women in week 24

07

Study locations

1 site
  • National Institue of Medical Sciences and Nutrition Salvador Zubirán
    Mexico City, 14000, Mexico
08

References and documents

Publications

  • Rosenberg IH. Sarcopenia: origins and clinical relevance. J Nutr. 1997 May;127(5 Suppl):990S-991S. doi: 10.1093/jn/127.5.990S. PubMed 9164280 ↗
  • Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova 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. PubMed 20392703 ↗
  • 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. doi: 10.1152/ajpendo.1993.265.2.E210. Erratum In: Am J Physiol 1993 Oct;265(4 Pt 1):followi. Am J Physiol Endocrinol Metab. 1993 Oct 1;265(1):1a. doi: 10.1152/ajpendo.1993.265.1.1-d. PubMed 8368290 ↗
  • 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. doi: 10.1093/oxfordjournals.aje.a009520. Erratum In: Am J Epidemiol 1999 Jun 15;149(12):1161. PubMed 9554417 ↗
  • 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. doi: 10.1046/j.1532-5415.2002.50217.x. PubMed 12028178 ↗
  • 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. doi: 10.1093/gerona/53a.3.m214. PubMed 9597054 ↗
  • 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. doi: 10.1152/jappl.2000.89.2.465. PubMed 10926627 ↗
  • 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. doi: 10.1046/j.1532-5415.2002.50216.x. PubMed 12028177 ↗
  • 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. PubMed 22142410 ↗
  • 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. doi: 10.1093/gerona/59.1.m48. PubMed 14718486 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01829009
Lead sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Responsible party
José Alberto Ávila Funes (PhD, National Institute of Medical Sciences and Nutrition, Salvador Zubiran) — Principal investigator
First posted
Apr 11, 2013
Primary completion
Apr 2013
Last update
Apr 22, 2015

Study contacts

JOSE ALBERTO AVILA FUNES, MD PhD
principal investigator · GERIATRICS CHIEF DEPARTMENT

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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