- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02172053
Resistance Exercise to Improve Fatigue in Workplace (REW) (REW)
16. april 2019 oppdatert av: Rosimeire Simprini Padula
Effectiveness of a Resistance Training Program in the Workplace to Muscle Fatigue Control in Industrial Workers: Cluster Randomized Controlled Trial.
Studies show that exercise resistance in workplace can reduce the symptoms of induced labor, however, the effectiveness of such programs depends on the characteristics of the training fatigue.
Thus, it is expected that this study the intervention group with training heavy using progressive resistance exercise protocol will be better in reducing fatigue when compare with light training group.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
Background: This study is randomized clinical trial with double-blinded.
The aim is evaluate the effectiveness the training heavy with resistance exercise program in the muscle fatigue control.
Methods: This is a randomized controlled trial by cluster, in which workers who participate in the intervention group will perform resistance exercise protocols; and workers in the comparative group held only stretching exercises and light resistance training with elastic bands.
Expected results: strong evidence that fatigue reducing after ten weeks in workers and improve in others outcomes.
Not found in literature studies in occupational evaluating this aspect of training.
Studietype
Intervensjonell
Registrering (Faktiske)
352
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Espirito Santo
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Cachoeiro de Itapemirim, Espirito Santo, Brasil, 29303300
- Centro Universitário São Camilo
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- sign informed consent
Exclusion Criteria:
- restriction by the medical department.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Compensatory Workplace Exercise (CWE)
Comparative Group will receive a light training protocol including warming up, stretching and resisted exercise using elastic bands.
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The comparative group will receive warming up and stretching and light resisted exercise with elastic bands.
The exercise will realize three times per week, 20 minutes for day in total 60 minutes per week.
With warming up for 5 minutes and 15 minutes of the specific training .
The exercise will realize in 3 series with 10 repetitions and rest 30 seconds between series.
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Eksperimentell: Individual Resistance Exercise (IRE)
Intervention group will receive training protocol including warming up, stretching a specific resistance training with increase progressive load.
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Intervention group will receive warming up and stretching, and a specific resistance training with increase progress load.
The exercise will realize three times per week, 20 minutes for day in total 60 minutes per week.
With warming up and stretching for 5 minutes and 15 minutes of the specific training.
The exercise will realize in 3 series with 10 repetitions and rest 30 seconds between series.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Need for Recovery
Tidsramme: up to 4 months
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Psychosocial risk factors and stress, resulting in work-induced fatigue, will be obtained by e Need for Recovery Scale (NFR).
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up to 4 months
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Fatigue
Tidsramme: up to 4 months
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1 RM test is the maximum amount of weight lifted once while performing a standardized exercise for muscle groups - elbow , knee and ankle flexors and extensors, trunk.
A weight according to the maximum capacity is chosen.
If a replay is completed, find the value of 1RM.
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up to 4 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Musculoskeletal symptoms
Tidsramme: Outcome measures will be assessed at baseline and after 4 months.
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Musculoskeletal symptoms (pain, tingling or numbness) will be assessed using the Nordic Questionnaire for Musculoskeletal.
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Outcome measures will be assessed at baseline and after 4 months.
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Level of physical activity
Tidsramme: Outcome measures will be assessed at baseline and after 4 months.
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Questionnaire Baeck will be used to identify the level of habitual physical activity
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Outcome measures will be assessed at baseline and after 4 months.
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Perceived exposure
Tidsramme: Outcome measures will be assessed at baseline and after 4 months.
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The perception of workers risk factors that may contribute to the development of musculoskeletal complaints will be evaluated through the Job Factors Questionnaire.
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Outcome measures will be assessed at baseline and after 4 months.
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Physical Fitness Assessment
Tidsramme: Outcome measures will be assessed at baseline and after 4 months.
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The physical assessment will be consider adipometry (body fat percentage) others variables.
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Outcome measures will be assessed at baseline and after 4 months.
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Productivity
Tidsramme: Outcome measures will be assessed at baseline and after 4 months.
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Productivity is measured by a single item General Health Questionnaire and Performance at Work
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Outcome measures will be assessed at baseline and after 4 months.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Rosimeire S Padula, Universidade Cidade de Sao Paulo
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Santos HG, Chiavegato LD, Valentim DP, Padula RS. Effectiveness of a progressive resistance exercise program for industrial workers during breaks on perceived fatigue control: a cluster randomized controlled trial. BMC Public Health. 2020 Jun 3;20(1):849. doi: 10.1186/s12889-020-08994-x.
- Santos HG, Chiavegato LD, Valentim DP, da Silva PR, Padula RS. Resistance training program for fatigue management in the workplace: exercise protocol in a cluster randomized controlled trial. BMC Public Health. 2016 Dec 22;16(1):1218. doi: 10.1186/s12889-016-3872-5.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. oktober 2015
Primær fullføring (Faktiske)
12. desember 2016
Studiet fullført (Faktiske)
3. mars 2017
Datoer for studieregistrering
Først innsendt
19. juni 2014
Først innsendt som oppfylte QC-kriteriene
23. juni 2014
Først lagt ut (Anslag)
24. juni 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. april 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. april 2019
Sist bekreftet
1. april 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 454.709
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .