Dataset Information

Aerobic endurance training versus relaxation training in patients with migraine (ARMIG): study protocol for a randomized controlled trial.

ABSTRACT: Migraine is one of the most frequent headache diseases and impairs patients' quality of life. Up to now, many randomized studies reported efficacy of prophylactic therapy with medications such as beta-blockers or anti-epileptic drugs. Non-medical treatment, like aerobic endurance training, is considered to be an encouraging alternative in migraine prophylaxis. However, there is still a lack of prospective, high-quality randomized trials. We therefore designed a randomized controlled trial to evaluate the efficacy of aerobic endurance training versus relaxation training in patients with migraine (ARMIG).This is a single-center, open-label, prospective, randomized trial. Sixty participants with migraine are randomly allocated to either endurance training or a relaxation group. After baseline headache diary documentation over at least 4 weeks, participants in the exercise group will start moderate aerobic endurance training under a sport therapist's supervision at least 3 times a week over a 12-week period. The second group will perform Jacobson's progressive muscle relaxation training guided by a trained relaxation therapist, also at least 3 times a week over a 12-week period. Both study arms will train in groups of up to 10 participants. More frequent individual training is possible. The follow-up period will be 12 weeks after the training period. The general state of health, possible state of anxiety or depression, impairments due to the headache disorder, pain-related disabilities, the headache-specific locus of control, and the motor fitness status are measured with standardized questionnaires.The study design is adequate to generate meaningful results. The trial will be helpful in gaining important data on exercise training for non-medical migraine prophylaxis.The trial is registered at ClinicalTrials.gov: NCT01407861.

SUBMITTER: Totzeck A

PROVIDER: S-EPMC3492021 | biostudies-literature | 2012 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Aerobic endurance training versus relaxation training in patients with migraine (ARMIG): study protocol for a randomized controlled trial.

Totzeck Andreas A Unverzagt Susanne S Bak Maja M Augst Pierre P Diener Hans-Christoph HC Gaul Charly C

Trials 20120427

<h4>Background</h4>Migraine is one of the most frequent headache diseases and impairs patients' quality of life. Up to now, many randomized studies reported efficacy of prophylactic therapy with medications such as beta-blockers or anti-epileptic drugs. Non-medical treatment, like aerobic endurance training, is considered to be an encouraging alternative in migraine prophylaxis. However, there is still a lack of prospective, high-quality randomized trials. We therefore designed a randomized cont ...[more]

PMID: 22540391

Similar Datasets

Project description:BackgroundMigraine is a primary neurological headache. Treatment of this condition includes medications; however, these medications, when given for a longer duration, can have side effects. If migraine is left untreated or undiagnosed, it is reported that around 2.5% of individuals with migraine may develop to have a chronic condition. This study aims to analyse the preliminary effectiveness of aerobic training on migraine pain level, sleep quality, quality of life, and resting-state brain waves among university students with migraine symptoms.Methodology88 university students with migraine symptoms are the target participants. 4 of 5 on the Migraine Screen Questionnaire, 5 of 7 on the International Classification of Headache Disorders 3rd edition (ICHD-3), and both genders aged 18-40 years will be included. The participants with a score of more than or equal to 5 on the visual aura rating scale, diagnosed with a secondary headache, pregnancy, medication for neurological and cardiorespiratory conditions, and unwilling to participate will be excluded. Based on the disability questionnaire, the participants will be randomly assigned to either of the three groups. The primary outcome is resting-state electroencephalography (EEG) brain, and the secondary outcomes are sleep quality, quality of life, and migraine pain level. The post-test assessments will be performed at week 6.ResultAfter the primary EEG analysis using MATLAB, the amplitude, frequency, frequency band ratio, and power spectrum density will be analysed. Mixed design analysis and intention-to-treat analysis will be used to assess the efficacy of aerobic training.DiscussionMigraines can be unpredictable, sometimes occurring without symptoms. If underdiagnosed or over-looked, it encompasses a serious of long-term effects. Hence with appropriate intervention, the symptoms can be prevented from worsening. But there is an unmet need for evidence-based non-pharmacological approaches to complement pharmacotherapy in migraine prevention. Moreover, an exercise intervention may be more suitable for people with migraine considering their tendency toward inactivity. Although some studies developed exercise programs for untrained patients with migraine, the outcome was primarily in terms of exercise capacity rather than the primary characteristics and secondary brain wave/ sleep quality changes, indicating the need for this study.

Project description:Individuals who are not engaged in treatment are commonly overlooked in the design of intervention trials targeting suicidal populations as a result of recruitment methodology that requires individuals to be referred from their current provider. In fact, research suggests that the majority of individuals who die by suicide have not been in contact with mental health services in the year before their death.A randomized controlled trial of two brief, one-session interventions for adults who are not engaged in mental health treatment. Inclusion criteria include 1) 18 years or older, 2) experiencing suicidal ideation in the past week, 3) have not received mental health treatment in the month prior to screening, 4) living within commuting distance to the research office, and 5) willing to consent to recording and assessment. Exclusion criteria are 1) non-English speaking and 2) significant cognitive impairment. Recruitment takes place in the community via flyers, radio, and online advertisements. Interested individuals are screened via telephone and those who are eligible attend a one-time in-person assessment and intervention appointment. During this appointment, they are randomized to a single-session intervention in which they are presented with either dialectical behavior therapy skills or supportive discussion and instruction in relaxation. Following the in-person appointment, participants complete three follow-up interviews via telephone at one-week, four-weeks, and twelve-weeks post-intervention. The primary outcomes are suicidal ideation, emotion dysregulation, and skills use. Secondary outcomes include depression, anxiety, self-efficacy, and treatment utilization. Exploratory outcomes are suicidal and intentionally self-injurious behaviors. Intent-to-treat analyses will be conducted on primary and secondary outcomes.Suicidal individuals who are not engaged in mental health treatment are an understudied and significantly at-risk group for death by suicide. A better understanding of this population, targeted efforts to recruit and engage these individuals, and developing effective interventions for this group are critical areas for investigation in the field that this trial seeks to address.Clinicaltrials.gov identifier: NCT02236325 ; Date of registration: 05-Sept-2014.

Project description:BACKGROUND:Post-stroke physical inactivity is explained by several factors related to the stroke, which have been suggested as the causes and consequences of functional declines and health problems. Therefore, it is important to increase physical activity levels and reduce the time spent in low-energy expenditure activities after a stroke. Since the maintenance of cardiorespiratory fitness is a significant predictor of physical activity levels post-stroke, it may be important to investigate whether aerobic training is effective in increasing physical activity levels and reducing the time spent in low-energy expenditure activities in this population. The efficacy of aerobic training on these variables is not well known. The primary objective of this trial will be to investigate the effects of aerobic treadmill training on physical activity levels and on time spent in low-energy expenditure activities in people with stroke. The secondary aim will be to evaluate the effects of the training on cardiorespiratory fitness, endurance, depression, mobility, quality of life, and participation. METHODS/DESIGN:A randomized controlled trial, with blinded assessments, will be performed in a community-based setting. Altogether, 22 adults with a diagnosis of stroke (>6 months) who are sedentary or insufficiently active will be included. Participants will be randomly assigned to either: (1) aerobic treadmill training (experimental group, at 60-80% of their heart rate reserve) or (2) walking outside (control group, below 40% of heart rate reserve). Both groups will attend 40-min training sessions, three times per week over 12 weeks, in groups of two to four participants, with a trained physiotherapist. Primary outcomes are physical activity levels and time spent in low-energy expenditure activities (Multi-sensor SenseWear Mini® and Human Activity Profile). Secondary outcomes are cardiorespiratory fitness (peak oxygen uptake VO2peak and ventilatory threshold), endurance, depression, mobility, quality of life, and participation. The effects of the training will be analyzed from the collected data using intention to treat. Between-group differences will be measured by two-way repeated measures ANOVA, considering the baseline, post-training, and 4-week follow-up. DISCUSSION:The results of this trial will likely provide valuable new information on the effects of aerobic treadmill training on physical activity levels and on time spent in low-energy expenditure activities of individuals with stroke, through changes in cardiorespiratory fitness. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02798237 . Registered on 13 June 2016.

Dataset Information

Aerobic endurance training versus relaxation training in patients with migraine (ARMIG): study protocol for a randomized controlled trial.

Publications

Aerobic endurance training versus relaxation training in patients with migraine (ARMIG): study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets