Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Resistance Exercise Effects on Fear Avoidance and Physical Function in Obese Older Adults With Low Back Pain

12. februar 2014 oppdatert av: University of Florida

Resistance Exercise Effects on Fear Avoidance Beliefs and Physical Function in Obese, Older Adults With Chronic Low Back Pain

The purpose of this study is to determine if a 4 month resistance exercise program reduces the severity of low back pain, pain-related fear avoidance and improves mobility compared to standard care.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

72

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Florida
      • Gainesville, Florida, Forente stater, 32607
        • UF&Shands Orthopaedics and Sports Medicine Institute

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

60 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • chronic low back pain for >6 months
  • >3 pain episodes per week
  • waist circumferences ≥102 cm for men
  • waist circumferences ≥ 88 cm for women
  • willing and able to participate in regular exercise for 14 weeks
  • using pain medications to control low back pain
  • free of abnormal cardiovascular responses during a screening graded maximal walk test

Exclusion Criteria:

  • unable to walk
  • participating in regular resistance exercise training (>3X week) in the past 6 months
  • pain symptoms are too severe and prevent strength testing or walking
  • acute back injury
  • spinal stenosis that precludes walking one block due to neurogenic claudication
  • back surgery within the past 2 years
  • current use of weight loss interventions (drugs; exercise interventions)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Standard care
Subjects will receive normal medical care and follow up during the four month study period if assigned to this group.
Annen: normal medical care and follow up
physical activity/ nutrition guidelines will be provided and reviewed with the participant as part of standard care; telephone contact will be made weekly to encourage adherence to the health guidelines
Aktiv komparator: Isolated Lumbar Resistance Exercise Program
Lumbar extension exercise protocol to increase strength and reduce pain.
Annen: Isolated Lumbar Resistance Exercise Program
lumbar extension, two set of 10-15 repetitions, once a week for two weeks; lumbar extension, one set of 10-15 repetitions, three times a week, week 3 to 4 months
Aktiv komparator: Total Body Resistance Exercise Program
Training protocol for 1 set for each exercise: leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, calf press and abdominal curl
Annen: Total Body Resistance Exercise Program
exercises: leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, calf press and abdominal curl, one set of 10-12 repetitions, three time per week, week one to 4 months

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
10 centimeter Visual Analog Scale (VAS); Change from Baseline at 1, 2, 3 and 4 Months
Tidsramme: Baseline, 1, 2, 3 and 4 Months
The VAS scale will range from 0-10 cm, where a rating of "0" reflects no pain, and a "10" rating represents "worst pain imaginable. Subjects will complete the VAS at the indicated time intervals to document any change in their pain levels.
Baseline, 1, 2, 3 and 4 Months
Tampa Scale of Kinesiophobia (TSK); Change from Baseline at 1, 2, 3 and 4 Months
Tidsramme: Baseline, 1, 2, 3 and 4 Months
Fear avoidance beliefs will be measured using the 11 item TSK. Subjects will complete the TSK at the indicated time intervals to document any change in their fear avoidance beliefs.
Baseline, 1, 2, 3 and 4 Months
Fear-Avoidance Beliefs Questionnaire (FABQ); Change from Baseline at 1, 2, 3 and 4 Months
Tidsramme: Baselinje, 1, 2, 3 and 4 Months
The FABQ is a tool based on theories of fear and avoidance behavior and focuses specifically on beliefs about how physical activity and work affect low back pain. Subjects will complete the FABQ at the indicated time intervals to document any change in their fear and avoidance behavior.
Baselinje, 1, 2, 3 and 4 Months
Pain Catastrophizing Scale (PCS); Change from Baseline at 1, 2, 3 and 4 Months
Tidsramme: Baseline, 1, 2, 3 and 4 Months
The PCS will be used to assess the effect of the chronic back pain on rumination on pain symptoms and helplessness. Subjects will complete the PCS at the indicated time intervals to document any change in their thoughts of their pain symptoms.
Baseline, 1, 2, 3 and 4 Months
Modified Oswestry Disability Index (ODI); Change from Baseline at 1, 2, 3 and 4 Months
Tidsramme: Baseline, 1, 2, 3 and 4 Months
The ODI is responsive to intervention treatments for low back pain, is reliable, and corresponds well with several global patient disability measures. Subjects will complete the ODI at the indicated time intervals to document any change in their low back pain.
Baseline, 1, 2, 3 and 4 Months
Roland Disability Survey (RDS); Change from Baseline at 1, 2, 3 and 4 Months
Tidsramme: Baseline, 1, 2, 3, and 4 Months
The RDS assesses physical disability and mental function with low back pain; this survey is sensitive to treatment interventions, and is reproducible and consistent and correlated well with other global ratings and disability measures. Subjects will complete the RDS at the indicated time intervals to document any change in their physical disability and mental function with their low back pain.
Baseline, 1, 2, 3, and 4 Months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Graded Treadmill Exercise Test; Change from Baseline at 4 Months
Tidsramme: Baseline and 4 Months
Maximal aerobic fitness, or oxygen consumption (VO2max) will be determined using a walking symptom-limited graded exercise test. Subjects will complete the exercise test at the indicated time intervals to document any change in their aerobic fitness.
Baseline and 4 Months
Chair Rise Time, Stair Climb Time and Gait Assessment; Change from Baseline at 4 Months
Tidsramme: Baseline and 4 Months
Chair rise time will be measured as the participant moves from a sitting to a full standing position. The time to walk up one flight of stairs will be measured by having the participants walk up one flight of stairs consisting of 12 steps as quickly as possible. Gait will be assessed by having the participants walk across a 26' portable walkway. Subjects will complete these motions at the indicated time intervals to document any change.
Baseline and 4 Months
7-day Pedometer Test; Change from Baseline at 4 Months
Tidsramme: 7 day period at Baseline and 4 Months
Community ambulation will be estimated using a 7-day pedometer test in which participants will wear a StepWatch® step activity monitor. Subjects will complete this test at the indicated time intervals to document any change in their ambulation.
7 day period at Baseline and 4 Months
Ultrasound Muscle Thickness; Change from Baseline at 4 Months
Tidsramme: Baseline and 4 Months
The ultrasound technique that will be used to capture muscle thickness changes in the paraspinal and multifidus muscles. Subjects will be tested at the indicated time intervals to document any change.
Baseline and 4 Months
Muscle Strength; Change from Baseline at 1, 2, 3 and 4 Months
Tidsramme: Baseline, 1, 2, 3 and 4 Months
Assessments of strength (1 repetition maximum, 1-RM) will be determined for all muscle groups trained. Subjects will be assessed at the indicated time intervals to document any change.
Baseline, 1, 2, 3 and 4 Months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Florida

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

1. november 2010

Primær fullføring (Faktiske)

1. februar 2014

Studiet fullført (Faktiske)

1. februar 2014

Datoer for studieregistrering

Først innsendt

5. november 2010

Først innsendt som oppfylte QC-kriteriene

29. november 2010

Først lagt ut (Anslag)

30. november 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

14. februar 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. februar 2014

Sist bekreftet

1. februar 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 258-2010

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. .

Abonnere