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Effects of Resistance Physical Exercise in Patients With Chronic Primary Insomnia (IER)

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical Exercise
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring insomnia, resistance physical exercise, stretching

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Sites / Locations

  • Centro de Estudos em Psicobiologia e Exercicio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Active Comparator

Arm Label

Insomnia Stretching Exercise

Control

Insomnia Physical Exercise

Arm Description

This group will realize stretching exercise

This group will not realize any type of intervention.

This group will realize resistance physical exercise

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 21, 2012
Last Updated
August 12, 2014
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Associação Fundo de Incentivo à Pesquisa
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1. Study Identification

Unique Protocol Identification Number
NCT01571115
Brief Title
Effects of Resistance Physical Exercise in Patients With Chronic Primary Insomnia
Acronym
IER
Official Title
Effects of Resistance Physical Exercise in Patients With Chronic Primary
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Associação Fundo de Incentivo à Pesquisa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
insomnia, resistance physical exercise, stretching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insomnia Stretching Exercise
Arm Type
Active Comparator
Arm Description
This group will realize stretching exercise
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will not realize any type of intervention.
Arm Title
Insomnia Physical Exercise
Arm Type
Active Comparator
Arm Description
This group will realize resistance physical exercise
Intervention Type
Behavioral
Intervention Name(s)
Physical Exercise
Primary Outcome Measure Information:
Title
Baseline
Description
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.
Time Frame
Pre-intervention
Secondary Outcome Measure Information:
Title
Intermediate Rating
Description
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.
Time Frame
After 2 months
Title
Post-Intervention
Description
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.
Time Frame
After 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Túlio de Mello
Organizational Affiliation
Universidade Federal do Estado de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Estudos em Psicobiologia e Exercicio
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22019457
Citation
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.
Results Reference
result
PubMed Identifier
20813580
Citation
Reid 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 Reference
result
PubMed Identifier
20572421
Citation
Passos 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.
Results Reference
result
PubMed Identifier
30328967
Citation
D'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.
Results Reference
derived

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Effects of Resistance Physical Exercise in Patients With Chronic Primary Insomnia

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