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

9. Juli 2014 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Brasilien
    • Bahia
      • Itabuna, Bahia, Brasilien, 45600-000
        • Rekrutierung
        • União Metropolitana de Ensino e Cultura (UNIME)
        • Kontakt:
        • Unterermittler:
          • Maria Luiza Comper, Msc.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 45 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Sonstiges: 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.
Aktiver Komparator: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in pain intensity during and after treatment
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Global Impression of Recovery
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Rosimeire Simprini Padula

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2014

Primärer Abschluss (Voraussichtlich)

1. Juni 2015

Studienabschluss (Voraussichtlich)

1. Dezember 2015

Studienanmeldedaten

Zuerst eingereicht

19. Juni 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Juli 2014

Zuerst gepostet (Schätzen)

11. Juli 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

11. Juli 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juli 2014

Zuletzt verifiziert

1. Juni 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 480.968

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