Trial record 5 of 611 for:    "Headache Disorders"

The Effect of Aerobic Exercise Training for Migraine Prevention.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Arão Belitardo de Oliveira, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01972607
First received: October 21, 2013
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

This study has been designed in order to know the effect of 12 weeks of aerobic exercise training for migraine prevention. We hypothesized that the exercise training could reduce the number of days with migraine and the number of attacks per month in the treated group.


Condition Intervention
Headache Disorders, Primary
Other: Exercise Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Aerobic Exercise Training for Migraine Prevention.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Frequency of Migraine/month [ Time Frame: Migraine frequency measured between the first and 4th weeks has been set as the "baseline" period, and will be compared to changes in frequency measured between weeks 12 to 16, which has been set as "post-intervention" period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Days with Migraine [ Time Frame: Days with migraine measured between the first and 4th weeks has been set as the "baseline" period, and will be compared to changes in days with migraine measured between weeks 12 to 16, which has been set as "post-intervention" period ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Maximal Oxygen Uptake [ Time Frame: Measurements of the maximal oxygen uptake has been performed at Week 1, which is set as "baseline" measurement, and at week 16, which is set as "post-intervention" measurement. ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: January 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Waiting list group
This group will receive the same treatment of the experimental group after the test-retest measurements.
Other: Exercise Training
12 weeks of aerobic exercise training performed 3x/week at moderate intensity with sessions of 40 min.
Experimental: Experimental group: aerobic exercise
This group will receive the treatment with aerobic exercise training
Other: Exercise Training
12 weeks of aerobic exercise training performed 3x/week at moderate intensity with sessions of 40 min.

Detailed Description:

The study will cover 16 weeks. The first 4 weeks has been designed as "baseline" period, to assess the migraine status and classification, colect blood exam, perform a cardiopulmonary exercise test to determine the maximal oxygen uptake, and fill psychometric questionnaires. The remaining 12 weeks will be the "intervention" period, where participants after randomization will be allocated to perform an aerobic exercise training (on treadmill) performed on a 3 times per week-based program of 40-min duration each session, or will wait for the equal period to repeat all the assessments, then begin the same exercise protocol.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Sedentary (> 6 month) healthy subjects and sedentary (> 6 month)subjects with migraine without aura, migraine with aura and chronic migraine;

Exclusion Criteria:

  • Physically active(> 1 day/week);
  • Tobacco user;
  • Alcohol or abuse drug user;
  • Taking any prescribed medication or, in the case of medication for migraine prevention, if taking < 6 months.
  • Having any cardiovascular, pulmonary, endocrine-metabolic, rheumatic or other neurologic disease or psychiatric disorder such as bipolar disorder and post-traumatic stress syndrome.
  • Undergoing surgical procedure less than 3 months before entering the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01972607

Locations
Brazil
Federal University of Sao Paulo
São Paulo, SP, Brazil, 04021-001
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Chair: Mario FP Peres, MD, PhD Federal University of Sao Paulo
  More Information

No publications provided

Responsible Party: Arão Belitardo de Oliveira, Prof. BS. Arão Belitardo de Oliveira, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01972607     History of Changes
Other Study ID Numbers: 081511
Study First Received: October 21, 2013
Last Updated: October 24, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Migraine, aerobic exercise, prevention

Additional relevant MeSH terms:
Headache
Migraine Disorders
Headache Disorders
Headache Disorders, Primary
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014