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Individual and Group Exercise Program for Industrial Workers With CANS: Randomized Controlled Trial (Exercise)

9 juli 2014 bijgewerkt door: Rosimeire Simprini Padula

Individual Exercise Program for Industrial Workers With Complaints of the Arm, Neck, or Shoulder (CANS): Study Protocol for a Randomized Controlled Trial.

This study is double-blinded RCT, whose aim is to assess if an individual exercise program is more effective to reduce complaints in neck, shoulders and arms that an group exercise program, in industrial workers.

The participants will be randomly allocated to receive 12 treatment sessions of individual exercise training (IET) or in group exercise training (GET). Sessions will last 30 minutes and will be held twice a week for 12 weeks. Participants will also be encouraged to continue the use of medicines and other health care.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This study is double-blinded RCT. Participants will be recruited from employees of the companies and industries located in the South of Bahia, Brazil or by referral from general practitioners, orthopedists, This study is single-blinded RCT, whose aim is to assess the efficacy of an individual exercise program for employees with complaints in neck, shoulders and arms. Participants will be recruited from employees of the companies and industries located in Brazil or by referral from general practitioners, orthopedists, neurologists or physiatrists.

The sample of 100 participants was determined by a sample size calculation designed to detect a clinically important difference of 10 points in the DASH Questionnaire (estimated standard deviation = 16,65 points). The following specifications will be considered: α=0.05, statistical power of 80% and follow-up loss of up to 15%.

The participants will be randomly allocated to receive 12 treatment sessions of individual exercise training (IET) or in group exercise training (GET). Sessions will last 30 minutes and will be held twice a week for 12 weeks. Participants will also be encouraged to continue the use of medicines and other health care.

Studietype

Ingrijpend

Inschrijving (Verwacht)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Brazilië
    • Bahia
      • Itabuna, Bahia, Brazilië, 45600-000
        • Werving
        • União Metropolitana de Ensino e Cultura (UNIME)
        • Contact:
        • Onderonderzoeker:
          • Maria Luiza Comper, Msc.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Clinical Diagnose of nontraumatic complaints of the arm, neck or shoulder with minimum intensity of 4 points on the visual analogue pain scale1, for at least 6 weeks2.

Exclusion Criteria:

  • Participants with contraindication to physical exercise
  • Participants who had been diagnosed with cervical disc hernia; shoulder instability; fractures; frozen shoulder; systemic diseases such as rheumatoid arthritis or diabetes; neurological diseases or other severe medical or psychiatric disorders

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Group Exercise Training (GET).
Group Exercise Program. The participants allocated into the GET Group will receive a general exercise training realized in group of workers. Each training session started with a five minute swarm-up by slowly moving the neck, upper back, shoulder, arms and hands through pain-free range of motion; followed by 30 minutes of stretching and strengthening exercises for neck, upper back, shoulder, arms and hands, performed in the standing posture, sitting or lying. For resistance exercise, will be adopted 3 sets of 10 repetitions with a load of 80% of 1 repetitions maximum 12. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises.
Ander: Group Exercise Program
The participants allocated into the GET Group will receive a general exercise training realized in group of workers. Each training session started with a five minute swarm-up by slowly moving the neck, upper back, shoulder, arms and hands through pain-free range of motion; followed by 30 minutes of stretching and strengthening exercises for neck, upper back, shoulder, arms and hands, performed in the standing posture, sitting or lying. For resistance exercise, will be adopted 3 sets of 10 repetitions with a load of 80% of 1 repetitions maximum. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises.
Actieve vergelijker: Individual Exercise Training
Individual Exercise Program. The participants allocated into the IET Group will receive a individual and specific strength training with seven different exercises, based in training programme describe by Andersen et al. and Sundstrup et al . During the intervention period, the training intensity were progressively increased according to the principle of periodization and progressive overload. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises. Experienced instructors supervised every other training session.
Ander: Individual Exercise Program

The participants allocated into the IET Group will receive a individual and specific strength training with seven different exercises, based in training programme describe by Andersen et al.3 and Sundstrup et al4.

During the intervention period, the training intensity were progressively increased according to the principle of periodization and progressive overload5. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises. Experienced instructors supervised every other training session.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in pain intensity during and after treatment
Tijdsspanne: 6th and 12th week after the start of treatment
Numeric Pain Rating Scale (NPRS) assesses the pain intensity levels perceived by the patient using likert 11-point scale (ranging from 0 to 10), with 0 representing "no pain" and 10 representing "the worst possible pain". The participants will be instructed to report the level of pain intensity in the last seven days.
6th and 12th week after the start of treatment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Global Impression of Recovery
Tijdsspanne: 6th and 12th week after treatment
The Global Perceived Effect Scale assesses the patient's perception, on a numerical scale, about how much their condition has improved or deteriorated comparing the onset of symptoms to the last few days. It is an 11-point numerical scale ranging -5 to +5, where the negative scores means that the patients are worsening, and the positive scores means refer positive that patients are recovering compared to the beginning. This scale has adequate clinimetric properties and it has been recommended for use as outcome measure for chronic pain trials 15.
6th and 12th week after treatment
Disability
Tijdsspanne: Baseline, 6th and 12th week after treatment
Disability Arm, Shoulder and Hand Questionnaire (DASH) is a questionnaire used to measure of disability and symptoms in the previous week of arm, shoulder and hand. The questionnaire uses a likert 5-point scale Likert (ranging from 1 to 5), with 1 means "no difficulty to perform, no symptom or no impact") and 5 means "unable to do, very severe symptom, or high impact". The total score ranges from 0 to 10, where 0 "no dysfunction" and 100 "severe impairment".
Baseline, 6th and 12th week after treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Rosimeire Simprini Padula

Onderzoekers

  • Hoofdonderzoeker: Rosimeire Padula, Doctor, Universidade Cidade de São Paulo (UNICID)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2014

Primaire voltooiing (Verwacht)

1 juni 2015

Studie voltooiing (Verwacht)

1 december 2015

Studieregistratiedata

Eerst ingediend

19 juni 2014

Eerst ingediend dat voldeed aan de QC-criteria

9 juli 2014

Eerst geplaatst (Schatting)

11 juli 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

11 juli 2014

Laatste update ingediend die voldeed aan QC-criteria

9 juli 2014

Laatst geverifieerd

1 juni 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 480.968

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