SLEEP DISTURBANCES Nec in ICD9CMNCT01404286
Resistance Training and Sleep in the Elderly
A study testing Physical exercise in people with SLEEP DISTURBANCES Nec in ICD9CM, run by Federal University of São Paulo at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 65 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- SLEEP DISTURBANCES Nec in ICD9CM
- What is being tested?
- Physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Nov 2009
- 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 65 to 80 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- male gender
- sedentary lifestyle
- age between 65 and 80 years
- clinically good health (able to practice physical exercise)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Session of Resistance Training on Sleep Patterns in the Elderly
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).
Read the detailed 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.
- Conditions
- SLEEP DISTURBANCES Nec in ICD9CM
- Being tested
- Physical exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseBehavioural
Also called Resistance Training, Sleep Patterns
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).
| Study group | Role | What they receive |
|---|---|---|
| physical exercise | Experimental | Experimental group: physical exercise Control group: no physical exercise Receives: Behavioral: Physical exercise |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep pattern measures in Polysomnography
Measured: The session of resistance training was performance about 16 hours before the polysomnographic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startJan 2008
- Primary completionNov 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SLEEP DISTURBANCES Nec in ICD9CMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Estudos em Psicobiologia e Exercício, Centro de Estudo Multidisciplinar em Sonolência e Acidentes - CEMSA, Instituto do Sono, Associação Fundo de Incentivo à Pesquisa
- Investigators
- Andrea M Esteves, PhD, Principal investigator, Universidade Federal de São PauloValter AR Viana, MSc, Principal investigator, Federal University of São PauloMarco Tulio de Mello, PhD, Study chair, Federal University of São PauloSergio Tufik, MD, PhD, Study chair, Federal University of São PauloRita A Boscolo, MSc, Principal investigator, Federal University of São PauloMarcos G Santana, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404286
- Sponsor's protocol ID
- 1059/06
- Status last verified
- Jan 2008
- First submitted
- 24 May 2011
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1111/j.1365-2869.2007.00576.x.
PubMed 17309764Atkinson G, Davenne D. Relationships between sleep, physical activity and human health. Physiol Behav. 2007 Feb 28;90(2-3):229-35. doi: 10.1016/j.physbeh.2006.09.015. Epub 2006 Oct 25.
PubMed 17067643Cassilhas 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. doi: 10.1249/mss.0b013e318060111f.
PubMed 17762374
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Session of Resistance Training on Sleep Patterns in the Elderly
- ClinicalTrials.gov ID
- NCT01404286
- Acronym / sponsor ID
- 1059/06
- Conditions
- SLEEP DISTURBANCES Nec in ICD9CM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Centro de Estudos em Psicobiologia e Exercício, Centro de Estudo Multidisciplinar em Sonolência e Acidentes - CEMSA, Instituto do Sono, Associação Fundo de Incentivo à Pesquisa
- Study start
- Jan 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical exercise | Experimental | Behavioral: Physical exerciseExperimental group: physical exercise Control group: no physical exercise |
| Control group | No intervention | – |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- male gender
- sedentary lifestyle
- age between 65 and 80 years
- clinically good health (able to practice physical exercise)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exerciseAlso: Resistance Training, Sleep PatternsAfter 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). | Behavioural | physical exercise |
Primary outcome
Sleep pattern measures in Polysomnography
Time frame: The session of resistance training was performance about 16 hours before the polysomnographic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
- Results publication: PubMed 17309764Chasens 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. doi: 10.1111/j.1365-2869.2007.00576.x.
- Results publication: PubMed 17067643Atkinson G, Davenne D. Relationships between sleep, physical activity and human health. Physiol Behav. 2007 Feb 28;90(2-3):229-35. doi: 10.1016/j.physbeh.2006.09.015. Epub 2006 Oct 25.
- Results publication: PubMed 17762374Cassilhas 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. doi: 10.1249/mss.0b013e318060111f.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea M Esteves, PhD principal investigator
Universidade Federal de São Paulo
Valter AR Viana, MSc principal investigator
Federal University of São Paulo
Marco Tulio de Mello, PhD study chair
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with SLEEP DISTURBANCES Nec in ICD9CM, run by Federal University of São Paulo at 1 site in Brazil.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jul 2011. 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 Brazil. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sleep pattern measures in Polysomnography (time frame: The session of resistance training was performance about 16 hours before the polysomnographic). 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 NCT01404286, which also lists 3 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 28 Jul 2011.