Effects of Aerobic Exercise Within a Behavioral Treatment Program for Chronic Headaches
14 de janeiro de 2013 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Real)
5
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216
- University of Mississippi Medical Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 64 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
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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).
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Experimental: 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.
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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).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Patient-reported headache-free days per week
Prazo: 2 weeks prior to treatment through 2 weeks post-treatment
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Patients are asked to report the number of days per week they do no experience headaches
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2 weeks prior to treatment through 2 weeks post-treatment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Headache Disability Index (HDI)
Prazo: baseline, 8 weeks, 10 weeks
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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."
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baseline, 8 weeks, 10 weeks
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Highest weekly headache intensity
Prazo: 2 weeks prior to treatment through 2 weeks post-treatment
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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.
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2 weeks prior to treatment through 2 weeks post-treatment
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Composite Depression/Anxiety Screening Scale (PHQ-4)
Prazo: 2 weeks prior to treatment through 2 weeks follow-up
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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.
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2 weeks prior to treatment through 2 weeks follow-up
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Donald Penzien, Ph.D., University of Mississippi Medical Center
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de dezembro de 2011
Conclusão Primária (Real)
1 de junho de 2012
Conclusão do estudo (Real)
1 de agosto de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
30 de janeiro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de janeiro de 2012
Primeira postagem (Estimativa)
2 de fevereiro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
16 de janeiro de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de janeiro de 2013
Última verificação
1 de janeiro de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2011-0044
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