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

12 februari 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

72

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.

Studie Locaties

  • Verenigde Staten
    • Florida
      • Gainesville, Florida, Verenigde Staten, 32607
        • UF&Shands Orthopaedics and Sports Medicine Institute

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

60 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

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: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Standard care
Subjects will receive normal medical care and follow up during the four month study period if assigned to this group.
Ander: 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
Actieve vergelijker: Isolated Lumbar Resistance Exercise Program
Lumbar extension exercise protocol to increase strength and reduce pain.
Ander: 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
Actieve vergelijker: 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
Ander: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
10 centimeter Visual Analog Scale (VAS); Change from Baseline at 1, 2, 3 and 4 Months
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Graded Treadmill Exercise Test; Change from Baseline at 4 Months
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

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

Sponsor

University of Florida

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 november 2010

Primaire voltooiing (Werkelijk)

1 februari 2014

Studie voltooiing (Werkelijk)

1 februari 2014

Studieregistratiedata

Eerst ingediend

5 november 2010

Eerst ingediend dat voldeed aan de QC-criteria

29 november 2010

Eerst geplaatst (Schatting)

30 november 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

14 februari 2014

Laatste update ingediend die voldeed aan QC-criteria

12 februari 2014

Laatst geverifieerd

1 februari 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 258-2010

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