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

NCT01664585 | Completed

• 2 other identifiers: R12006UKK Institute/173
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Headache; Physical Activity; Quality of Life

Keywords

headache; women; exercise; fear avoidance; physical activity

Outcome Measures

Primary Outcomes (1)

• Change from baseline in headache intensity at 6 months

  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).

  At baseline and follow-up after 6-months intervention

Secondary Outcomes (6)

• Amount and intensity of weekly physical activity

  At baseline, after 6-mo, 12-mo,and 24-mo

• Health economics

  At baseline, after 6-mo, 12-mo, and 24-mo

• Quality of Life (QoL)

  At baseline, after 6-mo, 12-mo, and 24-mo

• Fear avoidance beliefs

  At baseline, after 6-mo, 12-mo, and 24-mo

• Frequency of headache

  At baseline, after 6-mo, 12-mo, and 24-mo

Study Arms (2)

Training group

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Interventions

Training group BEHAVIORAL

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.

Also known as: Movement control of neck, Muscle training of the postural muscles of upper neck, Physical activity

Training group

Control BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• mental depression

Sponsors & Collaborators

• UKK Institute: lead
• Jyväskylä Central Hospital: collaborator
• University of Jyvaskyla: collaborator

Study Sites (3)

University of Jyväskylä

Jyväskylä, 40014, Finland

Location

Jyväskylä Central Hospital, Department of Physical and Rehabilitation Medicine

Jyväskylä, 40620, Finland

Location

UKK Institute

Tampere, 33500, Finland

Location

Related Publications (9)

• De Hertogh W, Vaes P, Devroey D, Louis P, Carpay H, Truijen S, Duquet W, Oostendorp R. Preliminary results, methodological considerations and recruitment difficulties of a randomised clinical trial comparing two treatment regimens for patients with headache and neck pain. BMC Musculoskelet Disord. 2009 Sep 23;10:115. doi: 10.1186/1471-2474-10-115.

  PMID: 19775434 BACKGROUND

• Fricton J, Velly A, Ouyang W, Look JO. Does exercise therapy improve headache? a systematic review with meta-analysis. Curr Pain Headache Rep. 2009 Dec;13(6):413-9. doi: 10.1007/s11916-009-0081-2. No abstract available.

  PMID: 19889280 BACKGROUND

• Fuller G, Kaye C. Headaches. BMJ. 2007 Feb 3;334(7587):254-6. doi: 10.1136/bmj.39090.652847.DE. No abstract available.

  PMID: 17272568 BACKGROUND

• Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL. Manipulation or mobilisation for neck pain. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004249. doi: 10.1002/14651858.CD004249.pub3.

  PMID: 20091561 BACKGROUND

• Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.

  PMID: 12221344 BACKGROUND

• Ylinen J, Takala EP, Nykanen M, Hakkinen A, Malkia E, Pohjolainen T, Karppi SL, Kautiainen H, Airaksinen O. Active neck muscle training in the treatment of chronic neck pain in women: a randomized controlled trial. JAMA. 2003 May 21;289(19):2509-16. doi: 10.1001/jama.289.19.2509.

  PMID: 12759322 BACKGROUND

• Ylinen J, Kautiainen H, Wiren K, Hakkinen A. Stretching exercises vs manual therapy in treatment of chronic neck pain: a randomized, controlled cross-over trial. J Rehabil Med. 2007 Mar;39(2):126-32. doi: 10.2340/16501977-0015.

  PMID: 17351694 BACKGROUND

• Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.

  PMID: 8455963 BACKGROUND

• British Association for the Study of Headache Guidelines for All Healthcare Professionals in the Diagnosis and Management of Migraine, Tension-Type, Cluster and Medication-Overuse Headache Writing Committee: EA MacGregor, TJ Steiner, PTG Davies 3rd edition (1st revision). 2010.

  RESULT

MeSH Terms

Conditions

Headache; Motor Activity

Interventions

Sensitivity Training Groups; Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marjo B Rinne, PhD

  UKK Institute

  STUDY DIRECTOR

• Riku P Nikander, PhD

  University of Jyvaskyla

  PRINCIPAL INVESTIGATOR

• Arja H Häkkinen, PhD

  University of Jyvaskyla

  PRINCIPAL INVESTIGATOR

• Jari J Ylinen, MD, DO, PhD

  Jyväskylä Central Hospital

  PRINCIPAL INVESTIGATOR

• Katriina Kukkonen-Harjula, MD

  Rehabilitation, South Karelia Social and Health Care District (Eksote)

  PRINCIPAL INVESTIGATOR

• Kari Tokola, MSci

  UKK Institute

  PRINCIPAL INVESTIGATOR

• Sanna Garam, MSci

  Helsinki Metropolia University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 14, 2012
• Study Start: September 17, 2012
• Primary Completion: July 3, 2015
• Study Completion: July 3, 2015
• Last Updated: May 5, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3)