Effects of Aerobic Exercise Within a Behavioral Treatment Program for Chronic Headaches
14. januar 2013 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
5
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Mississippi
-
Jackson, Mississippi, Forenede Stater, 39216
- University of Mississippi Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 64 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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).
|
|
Eksperimentel: 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).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient-reported headache-free days per week
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Headache Disability Index (HDI)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Donald Penzien, Ph.D., University of Mississippi Medical Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2011
Primær færdiggørelse (Faktiske)
1. juni 2012
Studieafslutning (Faktiske)
1. august 2012
Datoer for studieregistrering
Først indsendt
30. januar 2012
Først indsendt, der opfyldte QC-kriterier
30. januar 2012
Først opslået (Skøn)
2. februar 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. januar 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. januar 2013
Sidst verificeret
1. januar 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2011-0044
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .