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

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Associação Fundo de Incentivo à Pesquisa
Information provided by (Responsible Party):
Marco Tulio de Mello, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01571115
First received: March 21, 2012
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Insomnia
Behavioral: Physical Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Resistance Physical Exercise in Patients With Chronic Primary

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Baseline [ Time Frame: Pre-intervention ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: After 2 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: After 4 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 30
Study Start Date: January 2012
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insomnia Stretching Exercise
This group will realize stretching exercise
Behavioral: Physical Exercise
No Intervention: Control
This group will not realize any type of intervention.
Active Comparator: Insomnia Physical Exercise
This group will realize resistance physical exercise
Behavioral: Physical Exercise

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.

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01571115

Locations
Brazil
Centro de Estudos em Psicobiologia e Exercicio
São Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Associação Fundo de Incentivo à Pesquisa
Investigators
Principal Investigator: Marco Túlio de Mello Universidade Federal do Estado de São Paulo
  More Information

Publications:
Responsible Party: Marco Tulio de Mello, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01571115     History of Changes
Other Study ID Numbers: CEP 0147/11
Study First Received: March 21, 2012
Last Updated: August 12, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
insomnia
resistance physical exercise
stretching

ClinicalTrials.gov processed this record on September 16, 2014