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Effects of Exercise and Acupuncture on Chronic Insomnia

U

Universidade Federal de Goias

Status

Completed

Conditions

Chronic Insomnia

Treatments

Behavioral: Acupuncture
Behavioral: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT03171519
1.998.334

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

30 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

16 participants in 2 patient groups

Exercise
Active Comparator group
Treatment:
Behavioral: Exercise
Exercise + acupuncture
Experimental group
Treatment:
Behavioral: Exercise
Behavioral: Acupuncture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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