Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

14 gennaio 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

5

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Mississippi
      • Jackson, Mississippi, Stati Uniti, 39216
        • University of Mississippi Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 64 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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).
Sperimentale: 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.
Comportamentale: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient-reported headache-free days per week
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Headache Disability Index (HDI)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Mississippi Medical Center

Investigatori

  • Investigatore principale: Donald Penzien, Ph.D., University of Mississippi Medical Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2011

Completamento primario (Effettivo)

1 giugno 2012

Completamento dello studio (Effettivo)

1 agosto 2012

Date di iscrizione allo studio

Primo inviato

30 gennaio 2012

Primo inviato che soddisfa i criteri di controllo qualità

30 gennaio 2012

Primo Inserito (Stima)

2 febbraio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

16 gennaio 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 gennaio 2013

Ultimo verificato

1 gennaio 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2011-0044

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Behavioral Treatment for Chronic Headache- Exercise Version

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in United Kingdom

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi