Clinical trial NCT03171519: Effects of Exercise and Acupuncture on Chronic Insomnia
Official title: Effects of Exercise and Acupuncture on Chronic Insomnia: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Keywords: Physical activity
Disorders of onset and maintenance of sleep
non-pharmacological treatment
Acupuncture
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Chronic insomnia is a sleep disorder, characterized by difficulty in initiating and/or maintaining sleep, presence of non-restorative sleep, frequent awakenings or difficulty returning to sleep after each awakening, with a frequency of 3 nights/week, for at least 3 months. Pharmacologic therapy is the most commonly method used for its treatment, however, pharmacotherapy is associated with side effects. Thus, non-pharmacological therapies have been suggested as an alternative. Objective: To verify the effects of exercise associated with acupuncture on chronic insomnia. METHODS: 40 patients with chronic insomnia will be randomly assigned into two groups: CONTROL (n = 20) and ACUPUNCTURE (n = 20). The volunteers of the CONTROL group will be submitted to 12 weeks of aerobic exercise, performed on a treadmill, with frequency of 3 times / week and duration of 50 minutes / day. ACUPUNCTURE volunteers will perform aerobic exercise, following the protocol of the CONTROL group, plus acupuncture therapy once a week. The sleep evaluation will be evaluated by polysomnography and questionnaires. Expected Results: A 12-week combined therapy could potentiate the previously described positive effects of exercise in the treatment of chronic insomnia.


Eligibility criteria: Inclusion Criteria:

* age 30-60 years;
* clinical diagnosis of chronic insomnia according to the DSM-V (performed by a physician specialized in Sleep Medicine);
* insomnia complaint at least 3 times a week for at least 3 months;
* be physically inactive (exercise less than 2 times a week).

Exclusion Criteria:

* evidence that insomnia is directly related to medical conditions or side effects os medications;
* obstructive sleep apnea syndrome;
* ECG abnormalities that prevent physical exercise or use of beta-blockers;
* uncontrolled clinical diseases (diabetes, hypertension, cardiovascular, neurological or renal diseases);
* use or history of abuse of alcohol or psychoactive substances;
* use of sleeping pills\>2 times a week;
* shift workers.

Primary outcomes:
measure: Change from baseline polysomnography to 12 weeks
timeFrame: baseline, week 12
measure: Change from baseline anxiety to 12 weeks
timeFrame: baseline, week 12
measure: Change from baseline mood to 12 weeks
timeFrame: 12 weeks
measure: Change from baseline sleep quality to 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline quality of life to 12 weeks
timeFrame: baseline, week 12
measure: Change from baseline insomnia to 12 weeks
timeFrame: baseline, week 12
measure: Change from baseline sleep diary to 12 weeks
timeFrame: baseline, week 12
Secondary outcomes:
measure: Change from baseline serum serotonin to 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline cortisol to 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline Effort eletrocardiogram test to 12 weeks
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Jataí
country: Brazil
facility: Hospital Padre Thiago
state: Goias
Study officials:
References: