Effects of Resistance Physical Exercise in Patients With Chronic Primary Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Zolpidem or Exercise for Insomnia?

NCT03160404

Chronic Insomnia

COMPLETED EARLY_PHASE1

Exercise and Insomnia Study: The Effects of 1 Week of Exercise Training on Insomnia Severity

NCT04402021

Insomnia Chronic Insomnia, Primary

COMPLETED NA

Chronic Sleep Restriction

NCT01493661

Other Conditions That May Be A Focus of Clinical Attention

COMPLETED

A Personalized Behavioral Intervention to Improve Physical Activity, Sleep and Cognition in Sedentary Older Adults

NCT03959202

Sleep

COMPLETED PHASE1/PHASE2

Neuropsychological Sleep Physical Exercise Hypoxia

NCT01386814

Hypoxia

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Insomnia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Insomnia Stretching Exercise

This group will realize stretching exercise

Group Type ACTIVE_COMPARATOR

Physical Exercise

Intervention Type BEHAVIORAL

Control

This group will not realize any type of intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Insomnia Physical Exercise

This group will realize resistance physical exercise

Group Type ACTIVE_COMPARATOR

Physical Exercise

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical Exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No