Effects of Aerobic Exercise Within a Behavioral Treatment Program for Chronic Headaches
14 stycznia 2013 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
5
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Mississippi
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Jackson, Mississippi, Stany Zjednoczone, 39216
- University of Mississippi Medical Center
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 64 lata (Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Kobieta
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Eksperymentalny: 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.
|
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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Patient-reported headache-free days per week
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Headache Disability Index (HDI)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Donald Penzien, Ph.D., University of Mississippi Medical Center
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 grudnia 2011
Zakończenie podstawowe (Rzeczywisty)
1 czerwca 2012
Ukończenie studiów (Rzeczywisty)
1 sierpnia 2012
Daty rejestracji na studia
Pierwszy przesłany
30 stycznia 2012
Pierwszy przesłany, który spełnia kryteria kontroli jakości
30 stycznia 2012
Pierwszy wysłany (Oszacować)
2 lutego 2012
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
16 stycznia 2013
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
14 stycznia 2013
Ostatnia weryfikacja
1 stycznia 2013
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2011-0044
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