Condition category
Musculoskeletal Diseases
Date applied
27/10/2009
Date assigned
08/12/2009
Last edited
14/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Leani Souza Máximo Pereira

ORCID ID

Contact details

Programa de Pós Graduação em Ciências da Reabilitação
Departamento de Fisioterapia
Universidade Federal de Minas Gerais (UFMG)
Av Antonio Carlos
6627
Pampulha
Belo Horizonte - MG
31270-901
Brazil
+55 31 34094781
mesreab@eeffto.ufmg.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NCT

Study information

Scientific title

Effect of resistance exercise on plasma interleukin 6 (IL-6) and tumour necrosis factor-alpha (TNF-alpha), knee extensor muscle strength and functional capacity in older women: a single-blind randomised controlled cross-over trial

Acronym

Study hypothesis

The overall aim of the present study is to assess the impact of a programme of exercises performed with 75% of 1RM for ten weeks, on the plasma levels of interleukin 6 (IL-6) and tumour necrosis factor-alpha (TNF-alpha), knee extensors muscle strength and functional capacity of community-dwelling older women, particularly in those classified as pre-frail.

The specific research questions are:
1. What are the effects of a programme of ten-weeks of resistance training on muscle strength, IL-6, TNF-alpha and functionality?
2. Is there an association between knee extensor muscle strength and the plasma levels of IL-6 and TNF-alpha in pre-frail older women, evaluated after a ten-week resistance training programme?
3. Variables: Do knee extensor muscle strength and plasma levels of IL-6 and TNF-alpha influence the functional capacity in pre-frail older women evaluated after a ten-week resistance training programme?
4. Is there a change in knee extensor muscle strength, plasma levels of IL-6 and TNF-alpha and functional capacity in pre-frail older women after a ten-week resistance training programme?

Ethics approval

Ethics Committee for Research, Federal University of Minas Gerais (Universidade Federal de Minas Gerais [UFMG]) approved on the 5th December 2007 (ref: ETIC 321/2007)

Study design

Single-blind randomised controlled cross-over trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Knee extensor muscle strength/functional capacity in older women

Intervention

The subjects will participate in a strength training programme three times a week, lasting 60-minute each session, for 10 weeks. Two major muscle groups (knee extensors and flexors) will both be trained in three sets of eight repetitions, at 75% of 1RM. Each participant will be tested at baseline, after the end of the training programme and 10 weeks after programme completion. Every training session starts with ten minutes of warm-up and ends with ten minutes of cool-down. Bi-weekly, the 1RM test is repeated to guarantee the correct percentual, in case of gains. The exercises are done with ankle weights. One group will be evaluated, will receive the intervention and then, after ten weeks, will be evaluated again. Another group will be evaluated, will maintain their regular activities during ten weeks when they will be evaluated again, and then will start the intervention as in the first group (cross-over).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Plasma levels of IL-6 and TNF-alpha measured by enzyme-linked immunosorbent assay.

All primary and secondary outcomes will be assessed at baseline (before intervention), after intervention and 10 weeks post-intervention.

Secondary outcome measures

1. Static and isokinetic muscle strength of the knee extensors and flexors measured electronically by Byodex 3 Pro (Biodex Medical System, USA)
2. Functional capacity, measured by the 10-meter walk test and the Timed Up and Go test (TUG)
3. Clinical outcomes (pain, fatigue and self-perceived health)

All primary and secondary outcomes will be assessed at baseline (before intervention), after intervention and 10 weeks post-intervention.

Overall trial start date

01/12/2009

Overall trial end date

31/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female
2. Community-dwelling
3. Aged equal to or higher than 65 years-old
4. Classified as pre-frail according to the phenotype

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

26

Participant exclusion criteria

1. Elderly previously submitted to orthopedic surgeries on lower limbs and/or with a history of fracture
2. Those whom were not able to walk without support
3. Carriers of neurological diseases
4. Those whom presented any type of inflammatory disease in an acute stage
5. Neoplasia in activity in the last five years
6. Those whom were using medication that affect largely the immunological system
7. Those whom presented cognitive impairments detectable by the Mini-Mental State Examination (MMSE)

Recruitment start date

01/12/2009

Recruitment end date

31/01/2011

Locations

Countries of recruitment

Brazil

Trial participating centre

Programa de Pós Graduação em Ciências da Reabilitação
Belo Horizonte - MG
31270-901
Brazil

Sponsor information

Organisation

National Council of Scientific and Technological Development (CNPq) (Brazil)

Sponsor details

SEPN 507
Bloco B
Ed. Sede CNPq
Brasilia
70.740-901
Brazil
+55 61 21089000
presidencia@cnpq.br

Sponsor type

Government

Website

http://www.cnpq.br/atendimento

Funders

Funder type

Government

Funder name

National Council of Scientific and Technological Development (Conselho Nacional de Desenvolvimento Cientifico e Tecnológico [CNPq]) (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20667082
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21340244
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21971726

Publication citations

  1. Protocol

    Lustosa LP, Coelho FM, Silva JP, Pereira DS, Parentoni AN, Dias JM, Dias RC, Pereira LS, The effects of a muscle resistance program on the functional capacity, knee extensor muscle strength and plasma levels of IL-6 and TNF-alpha in pre-frail elderly women: a randomized crossover clinical trial--a study protocol., Trials, 2010, 11, 82, doi: 10.1186/1745-6215-11-82.

  2. Results

    Lustosa LP, Pacheco MG, Liu AL, Gonçalves WS, Silva JP, Pereira LS, Impact of static stretching on the gain in knee-extensor strength of community-dwelling older women after a training program., Rev Bras Fisioter, 14, 6, 497-502.

  3. Results

    Lustosa LP, Silva JP, Coelho FM, Pereira DS, Parentoni AN, Pereira LS, Impact of resistance exercise program on functional capacity and muscular strength of knee extensor in pre-frail community-dwelling older women: a randomized crossover trial., Rev Bras Fisioter, 15, 4, 318-324.

Additional files

Editorial Notes