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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01404286
Other study ID # 1059/06
Secondary ID
Status Completed
Phase N/A
First received May 24, 2011
Last updated July 27, 2011
Start date January 2008
Est. completion date November 2009

Study information

Verified date January 2008
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

Purpose: The objective of this study was to evaluate the influence of a session of resistance training on the sleep patterns of elderly people.

Methods: Forty men aged 65 to 80 years, sedentary and clinically healthy were divided into two groups: the control group (n=18) and the resistance group (n=22). Both groups underwent two polysomnography tests, one at baseline and another after either a resistance training session (One Repetition Maximum - Strength Test, resistance group) or without physical exercise (control group).


Description:

Upon completion of the baseline polysomnography (PSG), volunteers underwent body composition evaluations (total body mass, height and body mass index calculation) to characterize the sample. Three familiarization sessions were conducted with the exercise machines used in the study, and one repetition maximum test (1 RM) was completed in order to quantify the training session load. A PSG test was conducted on the same day of the exercise session for the resistance group, and the control group had a second PSG without exercise to compare the groups at both times.

The body composition assessment, the adaptations to the exercises and the training sessions were held at the Center for Psychobiology and Exercise Studies.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 2009
Est. primary completion date November 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 65 Years to 80 Years
Eligibility Inclusion Criteria:

- male gender

- sedentary lifestyle

- age between 65 and 80 years

- clinically good health (able to practice physical exercise)

Exclusion Criteria:

- known diseases of the cardiovascular, pulmonary, and musculoskeletal systems, diabetes

- profession in the field of physical exercise

- use of sleep medication

- disqualification based upon the clinical examination

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Physical exercise
After the adaptation sessions, volunteers underwent a session of resistance training at 60% of 1 RM organized as follows: 3 sets of 10 to 12 repetitions on each exercise machine with a 1 minute and 30 second interval between each set and an interval of 2 minutes between each exercise machine, giving a total duration of training between 50 and 60 minutes. The sequence of exercise machines used was alternated by body segment. The sessions were performed at the same time of day (morning) under controlled temperature conditions (24 ± 21C).

Locations

Country Name City State
Brazil Universidade Fderal de Sao Paulo Sao Paulo

Sponsors (5)

Lead Sponsor Collaborator
Federal University of São Paulo Associação Fundo de Incentivo à Pesquisa, Centro de Estudo Multidisciplinar em Sonolência e Acidentes - CEMSA, Centro de Estudos em Psicobiologia e Exercício, Instituto do Sono

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Atkinson G, Davenne D. Relationships between sleep, physical activity and human health. Physiol Behav. 2007 Feb 28;90(2-3):229-35. Epub 2006 Oct 25. Review. — View Citation

Cassilhas RC, Viana VA, Grassmann V, Santos RT, Santos RF, Tufik S, Mello MT. The impact of resistance exercise on the cognitive function of the elderly. Med Sci Sports Exerc. 2007 Aug;39(8):1401-7. — View Citation

Chasens ER, Sereika SM, Weaver TE, Umlauf MG. Daytime sleepiness, exercise, and physical function in older adults. J Sleep Res. 2007 Mar;16(1):60-5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep pattern measures in Polysomnography The session of resistance training was performance about 16 hours before the polysomnographic Yes