Effects of Exercise and Acupuncture on Chronic Insomnia

NCT ID: NCT03171519

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-25
• Study Completion Date: 2020-05-15

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.

Conditions

Chronic Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

The EXERCISE group will participate in an aerobic exercise program for 12 weeks, performed in intensity relative to 50% of reserve heart rate, on a treadmill.

Exercise + acupuncture

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

The EXERCISE group will participate in an aerobic exercise program for 12 weeks, performed in intensity relative to 50% of reserve heart rate, on a treadmill.

Acupuncture

Intervention Type: BEHAVIORAL

The ACUPUNCTURE group will participate in an aerobic exercise program following the protocol of the EXERCISE group, plus acupuncture therapy once a week.

Interventions

Exercise

The EXERCISE group will participate in an aerobic exercise program for 12 weeks, performed in intensity relative to 50% of reserve heart rate, on a treadmill.

Intervention Type: BEHAVIORAL

Acupuncture

The ACUPUNCTURE group will participate in an aerobic exercise program following the protocol of the EXERCISE group, plus acupuncture therapy once a week.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal de Goias

OTHER

Sponsor Role: lead

Responsible Party

Giselle Soares Passos

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Padre Thiago

Jatai, Goiás, Brazil

Countries

Brazil

Other Identifiers

1.998.334

Identifier Type: -

Identifier Source: org_study_id