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

ISRCTN	ISRCTN62824599
DOI	https://doi.org/10.1186/ISRCTN62824599
Secondary identifying numbers	NCT

Submission date: 27/10/2009
Registration date: 08/12/2009
Last edited: 14/02/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Leani Souza Máximo Pereira
Scientific

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

Phone	+55 31 34094781
Email	mesreab@eeffto.ufmg.br

Study information

Study design	Single-blind randomised controlled cross-over trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/12/2009
Completion date	31/01/2011

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target number of participants	26
Key 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
Key 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)
Date of first enrolment	01/12/2009
Date of final enrolment	31/01/2011

Locations

Countries of recruitment

Brazil

Study participating centre

Programa de Pós Graduação em Ciências da Reabilitação

Belo Horizonte - MG
31270-901
Brazil

Sponsor information

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

SEPN 507
Bloco B
Ed. Sede CNPq
Brasilia
70.740-901
Brazil

Phone	+55 61 21089000
Email	presidencia@cnpq.br
Website	http://www.cnpq.br/atendimento
"ROR"	https://ror.org/03swz6y49

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	28/07/2010	Yes	No
Results article	results	01/11/2010	Yes	No
Results article	results	01/08/2011	Yes	No