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SarcopeniaNCT01829009

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

A study testing Resistance Exercise Group in people with Sarcopenia, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 70 years and older, women only
Conditions the study is for
Sarcopenia
What is being tested?
Resistance Exercise Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteMexico
Study dates
Start not givento Apr 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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%)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • National Institue of Medical Sciences and Nutrition Salvador Zubirán

    Mexico City, Mexico City, 14000

Other trials in Mexico

About this study

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.

Conditions
Sarcopenia
Being tested
Resistance Exercise Group
Keywords
Sarcopenia, Elderly, Women, Resistance, Exercise
Medical subject headings
Sarcopenia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance Exercise GroupOther

    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

Study groups in NCT01829009
Study groupRoleWhat they receive
General Recommendations GroupNo interventionGeneral 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
Resistance Exercise GroupExperimentalAn 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
Receives: Other: Resistance Exercise Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in gait speed and functional status in sarcopenic older women

    Measured: improvement in gait speed and functional status in sarcopenic older women in weeks 6,12 and 24

Secondary outcomes (1)

  1. Increase in muscle mass in sarcopenic older women

    Measured: Increase in muscle mass in sarcopenic older women in week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2013 (estimated)
  2. Primary completionApr 2013

Why it stopped: Financial issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01829009
Sponsor's protocol ID
GER-887-13/14-1
Status last verified
Apr 2015
First submitted
2 Apr 2013
Last updated
22 Apr 2015
Results posted
No
Data monitoring committee
Yes

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.

    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.

    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.

    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

Questions about this trial

What is this clinical trial studying?

A study testing Resistance Exercise Group in people with Sarcopenia, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01829009, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.

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