Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Effects of Aerobic Exercise Within a Behavioral Treatment Program for Chronic Headaches

14 janvier 2013 mis à jour par: Donald Penzien, University of Mississippi Medical Center

Additive Effects of Aerobic Exercise to a Standard Behavioral Self-Management Program for Chronic Headaches

This proposed study seeks to examine whether adding an aerobic exercise prescription to a behavioral treatment program for chronic headaches will improve headache frequency and intensity, headache-related disability, and mood. It is hypothesized that participants who receive the exercise prescription at the start of treatment will show greater gains than those who receive the prescription halfway through treatment. It is also predicted that participants who begin the exercise component halfway through treatment will demonstrate greater improvement in the second half of treatment compared to the first half.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Aerobic exercise has long been discussed as a potential treatment for chronic headaches, though research in this area has been somewhat limited. It is warranted to consider the effectiveness of aerobic exercise as part of a larger headache management intervention. Early research in this area suggests that including an exercise component in conjunction with other effective forms of headache management, such as progressive muscle relaxation, biofeedback, and stress management, is associated with improvement in number of days with a headache, headache pain intensity and mood. None of these studies have specifically analyzed the effectiveness of the aerobic exercise component, though Lemestra et al. (2002) noted that participants who continued with their exercise regimen had better overall outcomes three months after the intervention ended.

Given the high rates of obesity and the fact that many people do not meet the minimum daily requirement for exercise, it is worthwhile to investigate the additive effect of exercise to behavioral headache interventions.

Type d'étude

Interventionnel

Inscription (Réel)

5

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Mississippi
      • Jackson, Mississippi, États-Unis, 39216
        • University of Mississippi Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 64 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • Diagnosis of chronic headache (according to International Headache Association (IHA) guidelines) by research personnel
  • Interested in receiving behavioral treatment for chronic headaches
  • Engaged in less than 60 minutes/week of physical activity in the past 3 months
  • Physically capable of engaging in a regular exercise routine
  • Interested in in taking part in a regular exercise routine
  • Regular internet access (at least once a week)

Exclusion Criteria:

  • Males
  • Unable to access internet at least once a week
  • Currently engaging in regular exercise
  • Not interested in participating in regular exercise
  • Not capable of safely exercising
  • Pregnant, nursing, or planning on becoming pregnant during the course of the study
  • Does not meet IHA diagnostic criteria for chronic headache
  • Not interested in behavioral headache treatment
  • Diagnosis of Medication Overuse Headache, or headaches related to a physical or neurological disorder
  • Cognitive or other forms of impairment that would decrease ability to fully engage in treatment

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Exercise-Start (ES)
The ES group will receive standard behavioral treatment in the Self-Management Training Program for Chronic Headaches. In addition to this material, participants in this group will receive an exercise prescription for 20 minutes of moderate-intensity aerobic activity at the beginning of Week 1. The exercise prescription will increase to 25 minutes in Week 2, and 30 minutes in Week 3. They are asked to maintain 30 minutes per day of exercise through Week 8. Participants choose the type of exercise, and have the option to break it up into 10-minute increments throughout the day.
Comportemental: Behavioral Treatment for Chronic Headache- Exercise Version
This behavioral treatment program consists of behavioral approaches to headache management: progressive muscle relaxation, stress-management training, and biofeedback. Skills for these techniques are presented during the clinic sessions, and supplemented with workbooks and audio CDs. In addition, all participants will receive a graduated exercise prescription of 20-30 minutes of moderate-intensity exercise, five days per week. They will be instructed to assess the intensity of their exercise using the Borg perceived exertion scale. Client contact sessions are as follows: Clinic Session (CS)1; Phone Session (PS) 1 (end of week1), CS 2 (end of week 4); PS 2 (end of week 6); CS 3 (end of week 8).
Expérimental: Exercise-Middle (EM)
The EM group will receive standard behavioral treatment in the Self-Management Training Program for Chronic Headaches.In addition to this material, participants in this group will receive an exercise prescription for 20 minutes of moderate-intensity aerobic activity at the beginning of Week 5. The exercise prescription will increase to 25 minutes in Week 6, and 30 minutes in Week 7. They are asked to maintain 30 minutes per day of exercise through Week 8. Participants choose the type of exercise, and have the option to break it up into 10-minute increments throughout the day.
Comportemental: Behavioral Treatment for Chronic Headache- Exercise Version
This behavioral treatment program consists of behavioral approaches to headache management: progressive muscle relaxation, stress-management training, and biofeedback. Skills for these techniques are presented during the clinic sessions, and supplemented with workbooks and audio CDs. In addition, all participants will receive a graduated exercise prescription of 20-30 minutes of moderate-intensity exercise, five days per week. They will be instructed to assess the intensity of their exercise using the Borg perceived exertion scale. Client contact sessions are as follows: Clinic Session (CS)1; Phone Session (PS) 1 (end of week1), CS 2 (end of week 4); PS 2 (end of week 6); CS 3 (end of week 8).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Patient-reported headache-free days per week
Délai: 2 weeks prior to treatment through 2 weeks post-treatment
Patients are asked to report the number of days per week they do no experience headaches
2 weeks prior to treatment through 2 weeks post-treatment

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Headache Disability Index (HDI)
Délai: baseline, 8 weeks, 10 weeks
HDI is a 25-item questionnaire that assesses headache-related functional and emotional disability in chronic headache sufferers. Participants respond to items using a 3-point scale: "yes," "sometimes," or "no."
baseline, 8 weeks, 10 weeks
Highest weekly headache intensity
Délai: 2 weeks prior to treatment through 2 weeks post-treatment
Patients are asked to report the the intensity of their worst headache during the past week, using a 0 (pain-free) to 10 (extremely intense pain) scale.
2 weeks prior to treatment through 2 weeks post-treatment
Composite Depression/Anxiety Screening Scale (PHQ-4)
Délai: 2 weeks prior to treatment through 2 weeks follow-up
This is a 4-item measure assessing symptoms of anxiety and depression in the past two weeks. Participants respond on a 4 point scale: 0=Not at all; 1=Several days; 2=More than half of the days; 3=Nearly every day. When this measure is administered during the course of treatment (weekly) participants will be asked to respond based on their experiences in the past week.
2 weeks prior to treatment through 2 weeks follow-up

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Mississippi Medical Center

Les enquêteurs

  • Chercheur principal: Donald Penzien, Ph.D., University of Mississippi Medical Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2011

Achèvement primaire (Réel)

1 juin 2012

Achèvement de l'étude (Réel)

1 août 2012

Dates d'inscription aux études

Première soumission

30 janvier 2012

Première soumission répondant aux critères de contrôle qualité

30 janvier 2012

Première publication (Estimation)

2 février 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

16 janvier 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 janvier 2013

Dernière vérification

1 janvier 2013

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2011-0044

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner