Exercise Training With Physically Active Lifestyle to Reduce Headache and Quality of Life (HEADEX)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Jyvaskyla
Jyväskylä Central Hospital
Information provided by (Responsible Party):
Marjo Rinne, PhD, UKK Institute
ClinicalTrials.gov Identifier:
NCT01664585
First received: August 7, 2012
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

The aim of this intervention study is to examine whether tailored exercise therapy training is effective and cost-effective to decrease headache frequency and intensity, reduce medication used for chronic headache and patients´ absence from work, improve their neck muscle force, cervical spine mobility, functional ability and quality of life, and increase general physical activity in chronic headache women at regular work during a 6-month intervention.

The intervention itself with pilot-tested upper-neck specific exercise regimen aims that patients would independently commit to train and exercise to reduce their headache, and thus increase their quality of life. In addition, reduced pain and frequency of headache may increase the objectively measured daily physical activity of chronic headache patients.


Condition Intervention
Headache
Physical Activity
Quality of Life
Behavioral: Training group
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: EXERCISE TRAINING WITH PHYSICALLY ACTIVE LIFESTYLE TO REDUCE HEADACHE AND INCREASE QUALITY OF LIFE. A Randomised Controlled Trial of the Effectiveness and Cost-effectiveness of Exercise Training and Physical Activity on Chronic Headache

Resource links provided by NLM:


Further study details as provided by UKK Institute:

Primary Outcome Measures:
  • Change from baseline in headache intensity at 6 months [ Time Frame: At baseline and follow-up after 6-months intervention ] [ Designated as safety issue: Yes ]
    The intensity of pain caused by headache is measured with Visual Analogue Scale (VAS)which is a measurement instrument for subjective experience. The participants specify their level of pain by indicating a position along a continuous line between two end-points (0 to 100).


Secondary Outcome Measures:
  • Amount and intensity of weekly physical activity [ Time Frame: At baseline, after 6-mo, 12-mo,and 24-mo ] [ Designated as safety issue: No ]
    Objective assessment of daily physical activity during 7 days by accelerometer Hookie AM 20 Activity Meter, Hookie Technologies Ltd, Espoo, Finland.

  • Health economics [ Time Frame: At baseline, after 6-mo, 12-mo, and 24-mo ] [ Designated as safety issue: No ]
    To evaluate the cost-effectiveness the calculations will be based on the self-reported absence from work (off work because of headache, possible disability pension because of headache), cost of medical and pharmaceutical claims for headache, ergonomic changes at work ergonomic changes at work, and adverse events of training. Furthermore, the costs of the intervention including the salaries of the study personnel, individual grants for the members of the research team, and costs related to examination of the subjects are entered to the total costs.

  • Quality of Life (QoL) [ Time Frame: At baseline, after 6-mo, 12-mo, and 24-mo ] [ Designated as safety issue: No ]
    The data will be collected with EORTC C-30 quality of life questionnaires (EORTC QOL C-30), the FACT Fatigue scale and mood, and the Beck depression inventory (BDI).

  • Fear avoidance beliefs [ Time Frame: At baseline, after 6-mo, 12-mo, and 24-mo ] [ Designated as safety issue: No ]
    Changes in fear-avoidance behaviour will be assessed with questionnaire on fear-avoidance beliefs (FABQ)addressing the behaviour both in work and leisure (Waddell et. al 1993)

  • Frequency of headache [ Time Frame: At baseline, after 6-mo, 12-mo, and 24-mo ] [ Designated as safety issue: Yes ]
    Participants keep diaries on daily basis in terms of number of headache periods and mail the diaries to the investigator every month,

  • Disability [ Time Frame: At baseline, after 6-mo, 12-mo, and 24-mo ] [ Designated as safety issue: No ]
    The participants will complete the Neck Disability Index (NDI)questionnaire with questions of ADL functioning


Estimated Enrollment: 120
Study Start Date: September 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Training group

The rationale and means for the exercise program are to

  1. Motivate and teach participants for postural and motor control and strengthening exercises
  2. Monitor and motivate to continue exercise training, and to increase their physical activity

Training is organised six times as a 60-min session during six months: two individually supervised sessions, and four following training sessions will be accomplished in groups of 10 participants guided by an experienced physical therapist. Three weekly similar home training sessions are recommended for participants. Information on amount of exercise sessions per week and repetitions of each exercise will be collected via exercise diary. To perform home training, a DVD and/or booklet will be provided to participants in the training group.

Behavioral: Training group
The 60-minute training sessions include a few mobilization techniques for upper neck. In detail, three different exercises concentrated on postural and motor control will be taught during the first two training sessions. Progressively, two additional exercise movements aiming at postural and motor control will be taught in the next session. After eight weeks, two muscle strength exercises utilising therapeutic rubber band will be included into the program. The aim of the rubber band exercises is eventually to achieve the load of 80% of maximal voluntary contraction. The participants in the training group are also instructed to increase their amount of physical activity progressively according to the current physical activity recommendations.
Other Names:
  • Movement control of neck
  • Muscle training of the postural muscles of upper neck
  • Physical activity
Sham Comparator: Control
The control group will receive six sessions of Transcutaneous Nervous Stimulation treatment (TNS) as a placebo treatment (0), and the participants in this group are recommended and encouraged to maintain their previous normal level of physical activity and exercise habits throughout the study without any supervision or home training programs.
Behavioral: Control
The control group will receive six sessions of Transcutaneous Nervous Stimulation treatment (TNS) as a placebo treatment (0) and the participants in control group are recommended and encouraged to maintain their previous normal level of physical activity and exercise habits throughout the study without any supervision or home training programs.

Detailed Description:

Tension-type,migraine and cervicogenic headache are the most common reasons for visits to a primary care physician among working women. Headache has major economic impact due to patients' absence from work, and pharmacy claims. Neck symptoms induce three percent of all visits to a primary care physician and 1 % of all costs in health care, and moreover, institutionalizing increase costs of treatment. Active treatment may offer cost-effective option for outpatients. In addition, there is no data showing how much headache/neck pain restricts participation in physical activity (PA) or other activities in society.

The purpose of this study is to investigate whether specific therapeutic exercises reduce cervicogenic headache cost-effectively, and simultaneously improve neck function and quality of life. The other aim is to evaluate the effect of exercises on daily PA in women with chronic headache.

The following hypotheses will be tested:

  1. Specific therapeutic exercises based on individual training reduce cost-effectively cervicogenic headache and improve neck function, and quality of life on women at regular work during a 6-month intervention
  2. The intervention increases general physical activity of women with cervicogenic headache
  3. The intervention assists them to manage the headache by way of exercising during the follow-up.
  4. Physical activity of women with chronic cervicogenic headache is lower than average in Finnish population.

The HEADEX intervention study is a randomized controlled trial. Volunteers, women at regular work and having ongoing status with chronic migraine and/or cervicogenic headache will be recruited using newspaper advertising, from the register of Finnish Migraine Society and occupational health care services in Helsinki, Tampere and Jyvaskyla. The study sample is restricted to women, as the headache is much more common in women. After recruitment, the eligibility of patients to participate is screened. In total, the aim is to obtain 120 women to participate. The two subsequent baseline assessments and follow-up of headaches with the diary between two months before the beginning of the intervention enable ensuring intensity and type of the headache and that it is chronic. Randomisation is centralised but the intervention will be accomplished and clustered in three study centres. Sample size has been estimated for the primary outcomes. The number of participant will be 60 women in treatment and 60 control group.

The 6 months exercise intervention consists of 6 supervised progressive exercise training sessions and home training program, and the participants are instructed to increase their PA. The main emphasis of the exercise program is to improve and relearn postural and movement control of neck, and later on strengthen the postural muscles. The exercise intervention consists of six supervised progressive exercise training sessions to teach rehabilitative training technique with similar home training program. Before the intervention, information on work ergonomics will be enquired and if needed, changes will be recommended. The control group will receive Transcutaneous Nervous Stimulation treatment (6 times) as a placebo treatment (intensity 0), and recommendation to maintain their PA at previous level. The follow-up is identical for both groups, and information on exercise frequency is collected up to 24 months follow-up.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women aged 18 to 60 and currently at work and aim to continue at same work at least two years
  • intensity of headache on Visual Analog Scale (VAS) has been equal or greater than 45 mm (scale 0-100) during last two months
  • Headache Impact Test TM [HIT-6 Scoring Interpretation Finland (Finnish) Version 1.1] 58/78 points

Exclusion Criteria:

  • severe degenerative changes at cervical vertebra or discus (including discus prolapse)
  • whiplash injury or injury, which is contraindication for exercise and active lifestyle
  • treated with manual therapy or physiotherapy within a previous month
  • changed medication known to affect headaches during a previous month
  • changed bifocals during previous month
  • athletic trainees (3 or more times per week)
  • alcoholic and/or drug addicts/ AUDIT The Alcohol Use Disorders Identification Test, Finnish version (Babor et al. 2001)
  • mental depression
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664585

Locations
Finland
Helsinki Metropolia University of Applied Sciences
Helsinki, Finland, 00079
Jyväskylä Central Hospital, Department of Physical and Rehabilitation Medicine
Jyväskylä, Finland, 40620
UKK Institute
Tampere, Finland, 33500
Sponsors and Collaborators
UKK Institute
University of Jyvaskyla
Jyväskylä Central Hospital
Investigators
Study Director: Marjo B Rinne, PhD UKK Institute
Principal Investigator: Riku P Nikander, PhD Helsinki Metropolia University of Applied Sciences, Department of Welfare and Human Functioning
Principal Investigator: Arja H Häkkinen, PhD, Professor University of Jyväskylä, Department of Health Sciences
Principal Investigator: Jari J Ylinen, MD, DO, PhD Jyväskylä Central Hospital, Department of Physical and Rehabilitation Medicine
Principal Investigator: Katriina Kukkonen-Harjula, MD UKK Institute
  More Information

Additional Information:
Publications:

Responsible Party: Marjo Rinne, PhD, Researcher, UKK Institute
ClinicalTrials.gov Identifier: NCT01664585     History of Changes
Other Study ID Numbers: R12006, UKK Institute/173
Study First Received: August 7, 2012
Last Updated: April 30, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by UKK Institute:
headache
women
exercise
fear avoidance
physical activity

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 02, 2014