InsomniaIERNCT01571115
Effects of Resistance Physical Exercise in Patients With Chronic Primary Insomnia
A study testing Physical Exercise in people with Insomnia, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
INTRODUCTION: The primary insomnia, according to the concepts of the DSM IV, is a disorder characterized by difficulty initiating or maintaining sleep, waking early or by non-restorative sleep, resulting in losses in the daily functioning of patients, such as lack of attention, concentration and memory, fatigue… Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Insomnia
- 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
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Mar 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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 30 and 55 years,
- clinical diagnosis of primary insomnia (DSM-IV, ICSD, 2005),
- complaints of insomnia for a period longer than 6 months and have at least one day complaining of prejudice resulting from insomnia (such as moodiness, irritability and/or cognitive impairment)
Who cannot join
- the use of psychoactive drugs,
- history of psychiatric disorders, shift workers,
- people with other sleep disorders and/or depression,
- significant abnormalities in laboratory tests and clinical trials have apnea/hypopnea index
- AHI > 15,
- present rate of periodic leg movements
- IMPP > 15,
- show abnormalities in heart tests (resting and exercise ECG) and blood that might impede the practice of physical exercises and practice regular physical exercise.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Estudos em Psicobiologia e Exercicio
São Paulo, São Paulo
About this study
Official title: Effects of Resistance Physical Exercise in Patients With Chronic Primary
INTRODUCTION: The primary insomnia, according to the concepts of the DSM IV, is a disorder characterized by difficulty initiating or maintaining sleep, waking early or by non-restorative sleep, resulting in losses in the daily functioning of patients, such as lack of attention, concentration and memory, fatigue, moodiness and irritability that are potentially associated with changes in sleep architecture, especially the reduction in slow-wave sleep. The most widely used therapy for the treatment of insomnia is the drug, but currently the resistive exercise is an important non-pharmacological intervention known to provide enough increase in slow wave sleep, and improve other parameters of sleep, as well as reducing symptoms of anxiety that are directly associated with the framework of insomnia. OBJECTIVE: To evaluate the effect of chronic resistive exercise in sleep patterns, the profile of mood and quality of life of patients with chronic primary insomnia. METHODOLOGY: 30 patients will be selected (male and female) with chronic primary insomnia. (Clinical diagnosis based on DSM-IV) referred for ambulatory sleep disorders Sleep Institute - AFIP. The protocol will be conducted at the Center for Psychobiology and Exercise (CEPE) of the AFIP and the Sleep Institute. Volunteers will be randomized into 2 groups of 15 participants, which will hold a resistive exercise and the other stretching exercise. This study will consist of three assessments: Pre-intervention (baseline), intermediate Rating (2 months) and post-intervention (at the end of 4 months). In the program of resistive exercise will be held 48 sessions that involve upper and lower limbs, abdominal and paraspinal region. It will be initially used a relative intensity 50% 1-RM. After 2 months of training intensity will be increased to 60% of 1-RM. Each exercise will be conducted in three sets of 12 repetitions, at intervals of 30 seconds between sets and one minute between each exercise. The total duration of the training session will be approximately 50 minutes. Before starting the training, participants will hold for 5 minutes stretching and warming on a bicycle ergometer (Life Cycle 9100) or treadmill (Life Fitness 9100) for the same period. After the session, the volunteers performed repeated stretches at the start of training. The group submitted to follow the practice of stretching protocol performed by Tworoger et al. that consist of 48 sessions of stretching for 60 minutes of low intensity, three times a week. The session will begin with 5 minutes of walking around the room, followed by 45 minutes of stretching exercises that involve the upper and lower limbs, 8 to 10 types for each region and end with 10 minutes of relaxation. STATISTICAL ANALYSIS: The variables of sleep, body composition and maximal repetition test will be analyzed using the software Statistica 7.0 (StaSoft, INC). The appropriate statistical test, parametric or nonparametric, will be chosen according to the data of the sample groups.
Read the detailed description
METHODOLOGY: 30 patients will be selected (male and female) with chronic primary insomnia. (Clinical diagnosis based on DSM-IV) referred for ambulatory sleep disorders Sleep Institute - AFIP. The protocol will be conducted at the Center for Psychobiology and Exercise (CEPE) of the AFIP and the Sleep Institute. Each patient will undergo an initial interview that will aim to clarify the objectives and procedures of the protocol, as well as obtaining the signature of the Consent for Participation in Research. During the interview, a questionnaire will be applied (Sleep Quality Index in Pittsburgh) (68) for assessment of subjective sleep complaints and depression scale (Beck Depression Inventory, BDI) (69). Then the patient will be submitted to general clinical examination, blood collection and conduct examinations and resting electrocardiograms. Later, it will be subjected to a polysomnographic procedures. Volunteers will be randomized into 3 groups of 10 participants, which will hold a resistive exercise and the other stretching exercise and other will be a control group. Inclusion criteria are: age between 30 and 55 years, clinical diagnosis of primary insomnia (DSM-IV, ICSD, 2005), complaints of insomnia for a period longer than 6 months and have at least one day complaining of prejudice resulting from insomnia (such as moodiness, irritability and/or cognitive impairment). The non-inclusion criteria are: the use of psychoactive drugs, history of psychiatric disorders, shift workers, people with other sleep disorders and/or depression, significant abnormalities in laboratory tests and clinical trials have apnea/hypopnea index - AHI> 15, present rate of periodic leg movements - IMPP> 15, show abnormalities in heart tests (resting and exercise ECG) and blood that might impede the practice of physical exercises and practice regular physical exercise. This study will consist of three assessments: Pre-intervention (baseline), intermediate Rating (2 months) and post-intervention (at the end of 4 months). In each evaluation the volunteers must attend the lab of CEPE to achieve the following: blood collection, will be carried out in fast, always in the morning, body composition assessment, will be performed later to collect blood, a repeat maximum test - 1RM - only group that is performing the exercise resistance, actigraphy and sleep diary (15 days); polysomnographic studies and questionnaires. In the program of resistive exercise will be held 48 sessions that involve upper and lower limbs, abdominal and paraspinal region. There will be 4 exercises for upper limb: biceps, triceps, back and chest; 4 for the lower limbs: flexors, extensors, abductors and adductors, an exercise in trunk flexion to the region of the abdomen and an extension to the paravertebral trunk. It will be initially used a relative intensity 50% 1-RM. After 2 months of training intensity will be increased to 60% of 1-RM. Each exercise will be conducted in three sets of 12 repetitions, at intervals of 30 seconds between sets and one minute between each exercise. The total duration of the training session will be approximately 50 minutes. Before starting the training, participants will hold for 5 minutes stretching and warming on a bicycle ergometer (Life Cycle 9100) or treadmill (Life Fitness 9100) for the same period. After the session, the volunteers performed repeated stretches at the start of training. The group submitted to follow the practice of stretching protocol performed by Tworoger et al. that consist of 48 sessions of stretching for 60 minutes of low intensity, three times a week. The session will begin with 5 minutes of walking around the room, followed by 45 minutes of stretching exercises that involve the upper and lower limbs, 8 to 10 types for each region and end with 10 minutes of relaxation.
- Conditions
- Insomnia
- Being tested
- Physical Exercise
- Keywords
- insomnia, resistance physical exercise, stretching
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Insomnia Stretching Exercise | Active comparator | This group will realize stretching exercise Receives: Behavioral: Physical Exercise |
| Control | No intervention | This group will not realize any type of intervention. |
| Insomnia Physical Exercise | Active comparator | This group will realize resistance physical exercise Receives: Behavioral: Physical Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline
In each evaluation the volunteers must attend the lab of CEPE to achieve the following: blood collection, will be carried out in fast, always in the morning, body composition assessment, will be performed later to collect blood, a repeat maximum test - 1RM - only group that is performing the exercise resistance, actigraphy and sleep diary (15 days); polysomnographic studies and questionnaires.
Measured: Pre-intervention
Secondary outcomes (2)
Intermediate Rating
n each evaluation the volunteers must attend the lab of CEPE to achieve the following: blood collection, will be carried out in fast, always in the morning, body composition assessment, will be performed later to collect blood, a repeat maximum test - 1RM - only group that is performing the exercise resistance; polysomnographic studies and questionnaires.
Measured: After 2 months
Post-Intervention
In each evaluation the volunteers must attend the lab of CEPE to achieve the following: blood collection, will be carried out in fast, always in the morning, body composition assessment, will be performed later to collect blood, actigraphy and sleep diary (15 days); polysomnographic studies and questionnaires.
Measured: After 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Associação Fundo de Incentivo à Pesquisa
- Responsible party
- Principal investigator, Marco Tulio de Mello, Federal University of São Paulo
- Investigators
- Marco Túlio de Mello, Principal investigator, Universidade Federal do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571115
- Sponsor's protocol ID
- CEP 0147/11
- Acronym
- IER
- Status last verified
- Aug 2014
- First submitted
- 21 Mar 2012
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Passos GS, Poyares D, Santana MG, D'Aurea CV, Youngstedt SD, Tufik S, de Mello MT. Effects of moderate aerobic exercise training on chronic primary insomnia. Sleep Med. 2011 Dec;12(10):1018-27. doi: 10.1016/j.sleep.2011.02.007. Epub 2011 Oct 22.
PubMed 22019457Reid KJ, Baron KG, Lu B, Naylor E, Wolfe L, Zee PC. Aerobic exercise improves self-reported sleep and quality of life in older adults with insomnia. Sleep Med. 2010 Oct;11(9):934-40. doi: 10.1016/j.sleep.2010.04.014. Epub 2010 Sep 1.
PubMed 20813580Passos GS, Poyares D, Santana MG, Garbuio SA, Tufik S, Mello MT. Effect of acute physical exercise on patients with chronic primary insomnia. J Clin Sleep Med. 2010 Jun 15;6(3):270-5.
PubMed 20572421D'Aurea CVR, Poyares D, Passos GS, Santana MG, Youngstedt SD, Souza AA, Bicudo J, Tufik S, de Mello MT. Effects of resistance exercise training and stretching on chronic insomnia. Braz J Psychiatry. 2019 Jan-Feb;41(1):51-57. doi: 10.1590/1516-4446-2018-0030. Epub 2018 Oct 11.
PubMed 30328967
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Physical Exercise in Patients With Chronic Primary
- ClinicalTrials.gov ID
- NCT01571115
- Acronym / sponsor ID
- IER / CEP 0147/11
- Conditions
- Insomnia
- Keywords
- insomnia, resistance physical exercise, stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Associação Fundo de Incentivo à Pesquisa
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Apr 2012 (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.
INTRODUCTION: The primary insomnia, according to the concepts of the DSM IV, is a disorder characterized by difficulty initiating or maintaining sleep, waking early or by non-restorative sleep, resulting in losses in the daily functioning of patients, such as lack of attention, concentration and memory, fatigue, moodiness and irritability that are potentially associated with changes in sleep architecture, especially the reduction in slow-wave sleep. The most widely used therapy for the treatment of insomnia is the drug, but currently the resistive exercise is an important non-pharmacological intervention known to provide enough increase in slow wave sleep, and improve other parameters of sleep, as well as reducing symptoms of anxiety that are directly associated with the framework of insomnia. OBJECTIVE: To evaluate the effect of chronic resistive exercise in sleep patterns, the profile of mood and quality of life of patients with chronic primary insomnia. METHODOLOGY: 30 patients will be selected (male and female) with chronic primary insomnia. (Clinical diagnosis based on DSM-IV) referred for ambulatory sleep disorders Sleep Institute - AFIP. The protocol will be conducted at the Center for Psychobiology and Exercise (CEPE) of the AFIP and the Sleep Institute. Volunteers will be randomized into 2 groups of 15 participants, which will hold a resistive exercise and the other stretching exercise. This study will consist of three assessments: Pre-intervention (baseline), intermediate Rating (2 months) and post-intervention (at the end of 4 months). In the program of resistive exercise will be held 48 sessions that involve upper and lower limbs, abdominal and paraspinal region. It will be initially used a relative intensity 50% 1-RM. After 2 months of training intensity will be increased to 60% of 1-RM. Each exercise will be conducted in three sets of 12 repetitions, at intervals of 30 seconds between sets and one minute between each exercise. The total duration of the training session will be approximately 50 minutes. Before starting the training, participants will hold for 5 minutes stretching and warming on a bicycle ergometer (Life Cycle 9100) or treadmill (Life Fitness 9100) for the same period. After the session, the volunteers performed repeated stretches at the start of training. The group submitted to follow the practice of stretching protocol performed by Tworoger et al. that consist of 48 sessions of stretching for 60 minutes of low intensity, three times a week. The session will begin with 5 minutes of walking around the room, followed by 45 minutes of stretching exercises that involve the upper and lower limbs, 8 to 10 types for each region and end with 10 minutes of relaxation. STATISTICAL ANALYSIS: The variables of sleep, body composition and maximal repetition test will be analyzed using the software Statistica 7.0 (StaSoft, INC). The appropriate statistical test, parametric or nonparametric, will be chosen according to the data of the sample groups.
Detailed description
METHODOLOGY: 30 patients will be selected (male and female) with chronic primary insomnia. (Clinical diagnosis based on DSM-IV) referred for ambulatory sleep disorders Sleep Institute - AFIP. The protocol will be conducted at the Center for Psychobiology and Exercise (CEPE) of the AFIP and the Sleep Institute. Each patient will undergo an initial interview that will aim to clarify the objectives and procedures of the protocol, as well as obtaining the signature of the Consent for Participation in Research. During the interview, a questionnaire will be applied (Sleep Quality Index in Pittsburgh) (68) for assessment of subjective sleep complaints and depression scale (Beck Depression Inventory, BDI) (69). Then the patient will be submitted to general clinical examination, blood collection and conduct examinations and resting electrocardiograms. Later, it will be subjected to a polysomnographic procedures. Volunteers will be randomized into 3 groups of 10 participants, which will hold a resistive exercise and the other stretching exercise and other will be a control group. Inclusion criteria are: age between 30 and 55 years, clinical diagnosis of primary insomnia (DSM-IV, ICSD, 2005), complaints of insomnia for a period longer than 6 months and have at least one day complaining of prejudice resulting from insomnia (such as moodiness, irritability and/or cognitive impairment). The non-inclusion criteria are: the use of psychoactive drugs, history of psychiatric disorders, shift workers, people with other sleep disorders and/or depression, significant abnormalities in laboratory tests and clinical trials have apnea/hypopnea index - AHI> 15, present rate of periodic leg movements - IMPP> 15, show abnormalities in heart tests (resting and exercise ECG) and blood that might impede the practice of physical exercises and practice regular physical exercise. This study will consist of three assessments: Pre-intervention (baseline), intermediate Rating (2 months) and post-intervention (at the end of 4 months). In each evaluation the volunteers must attend the lab of CEPE to achieve the following: blood collection, will be carried out in fast, always in the morning, body composition assessment, will be performed later to collect blood, a repeat maximum test - 1RM - only group that is performing the exercise resistance, actigraphy and sleep diary (15 days); polysomnographic studies and questionnaires. In the program of resistive exercise will be held 48 sessions that involve upper and lower limbs, abdominal and paraspinal region. There will be 4 exercises for upper limb: biceps, triceps, back and chest; 4 for the lower limbs: flexors, extensors, abductors and adductors, an exercise in trunk flexion to the region of the abdomen and an extension to the paravertebral trunk. It will be initially used a relative intensity 50% 1-RM. After 2 months of training intensity will be increased to 60% of 1-RM. Each exercise will be conducted in three sets of 12 repetitions, at intervals of 30 seconds between sets and one minute between each exercise. The total duration of the training session will be approximately 50 minutes. Before starting the training, participants will hold for 5 minutes stretching and warming on a bicycle ergometer (Life Cycle 9100) or treadmill (Life Fitness 9100) for the same period. After the session, the volunteers performed repeated stretches at the start of training. The group submitted to follow the practice of stretching protocol performed by Tworoger et al. that consist of 48 sessions of stretching for 60 minutes of low intensity, three times a week. The session will begin with 5 minutes of walking around the room, followed by 45 minutes of stretching exercises that involve the upper and lower limbs, 8 to 10 types for each region and end with 10 minutes of relaxation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insomnia Stretching Exercise | Active comparator | Behavioral: Physical ExerciseThis group will realize stretching exercise |
| Control | No intervention | –This group will not realize any type of intervention. |
| Insomnia Physical Exercise | Active comparator | Behavioral: Physical ExerciseThis group will realize resistance physical exercise |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 30 and 55 years,
- clinical diagnosis of primary insomnia (DSM-IV, ICSD, 2005),
- complaints of insomnia for a period longer than 6 months and have at least one day complaining of prejudice resulting from insomnia (such as moodiness, irritability and/or cognitive impairment)
Key exclusion criteria (8 listed)
- the use of psychoactive drugs,
- history of psychiatric disorders, shift workers,
- people with other sleep disorders and/or depression,
- significant abnormalities in laboratory tests and clinical trials have apnea/hypopnea index
- AHI > 15,
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 Exercise | Behavioural | Insomnia Physical Exercise, Insomnia Stretching Exercise |
Primary outcome
Baseline
Time frame: Pre-intervention
In each evaluation the volunteers must attend the lab of CEPE to achieve the following: blood collection, will be carried out in fast, always in the morning, body composition assessment, will be performed later to collect blood, a repeat maximum test - 1RM - only group that is performing the exercise resistance, actigraphy and sleep diary (15 days); polysomnographic studies and questionnaires.
2 secondary outcomes
Intermediate Rating
Time frame: After 2 months
Post-Intervention
Time frame: After 4 months
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 15 Aug 2014.
- Results publication: PubMed 22019457Passos GS, Poyares D, Santana MG, D'Aurea CV, Youngstedt SD, Tufik S, de Mello MT. Effects of moderate aerobic exercise training on chronic primary insomnia. Sleep Med. 2011 Dec;12(10):1018-27. doi: 10.1016/j.sleep.2011.02.007. Epub 2011 Oct 22.
- Results publication: PubMed 20813580Reid KJ, Baron KG, Lu B, Naylor E, Wolfe L, Zee PC. Aerobic exercise improves self-reported sleep and quality of life in older adults with insomnia. Sleep Med. 2010 Oct;11(9):934-40. doi: 10.1016/j.sleep.2010.04.014. Epub 2010 Sep 1.
- Results publication: PubMed 20572421Passos GS, Poyares D, Santana MG, Garbuio SA, Tufik S, Mello MT. Effect of acute physical exercise on patients with chronic primary insomnia. J Clin Sleep Med. 2010 Jun 15;6(3):270-5.
- Derived from this study: PubMed 30328967D'Aurea CVR, Poyares D, Passos GS, Santana MG, Youngstedt SD, Souza AA, Bicudo J, Tufik S, de Mello MT. Effects of resistance exercise training and stretching on chronic insomnia. Braz J Psychiatry. 2019 Jan-Feb;41(1):51-57. doi: 10.1590/1516-4446-2018-0030. Epub 2018 Oct 11.
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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.
Marco Túlio de Mello principal investigator
Universidade Federal do Estado de 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 Insomnia, 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 3 inclusion and 8 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 15 Aug 2014. 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?
Baseline (time frame: Pre-intervention). 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 NCT01571115, which also lists 4 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 15 Aug 2014.