Effects of Resistance Physical Exercise in Patients With Chronic Primary Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

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.
    

Intervention name(s): Physical Exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: insomnia; resistance physical exercise; stretching