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Physical Activity, Fatigue, Sleep, and Inflammation (ABLE)

7. marts 2016 opdateret af: University of Alabama at Birmingham

Physical Activity Benefits After Breast Cancer: Exploring Cytokine Mechanisms

The purpose of the study is to examine the benefits of physical activity for breast cancer survivors related to muscle strength, tiredness, and sleep quality. Also, the study will determine the potential role of inflammation in these benefits.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Our previous research has shown that increases in physical activity can improve the health and well-being of breast cancer survivors. The current study will determine whether the physical activity increases are adequate for improved health by measuring physical activity (accelerometer and self-report), muscle strength, fatigue, and sleep. Moreover, few studies have examined cytokine changes in cancer survivors after participation in a physical activity behavior change intervention with a mechanistic focus on cytokines which may influence the muscle strength, fatigue, and sleep response to the intervention.

Seventy-four female, breast cancer survivors are being recruited within a 50-miles radius of Springfield, IL. Participants will be in the study for approximately 5 months. Participants will be asked to complete a questionnaire at the beginning of the study and 3 months later. A blood sample will be drawn to determine serum cytokine levels.

Volunteers will be randomly assigned to 1 of 2 study groups. The intervention group will participate in a 3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands.

This randomized controlled trial includes the following study aims:

Study aim 1: The intervention group will be compared with the control group to examine the change in physical activity, muscle strength, fatigue, and sleep dysfunction before and after participation in a physical activity intervention.

Study aim 2: To investigate mechanisms that may underlie the effects of the physical activity intervention on muscle strength, fatigue, and sleep, we will compare the intervention group with the control group in terms of changes in cytokine markers of inflammation and evaluate whether such changes are consistent with and may mediate changes in muscle strength, fatigue, and sleep dysfunction.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

49

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Illinois
      • Springfield, Illinois, Forenede Stater, 62702
        • Southern Illinois University School of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Female, 30 to 70 years of age, with first diagnosis of ductal carcinoma in situ (DCIS) or Stage I or Stage II breast cancer
  • If chemotherapy or radiation therapy was received, the patient must be at least 4 weeks status post final primary treatment administration to allow treatment related cytokine changes to resolve. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc.
  • If the patient has undergone a surgical procedure, she must be at least 8 weeks post-procedure.
  • English speaking
  • Medical clearance for participation provided by primary care physician or oncologist
  • Postmenopausal
  • Average fatigue over the past week of ≥ 3 on a 1 to 10 Likert scale or sleep dysfunction ≥ 1 on a 0 to 3 Likert scale
  • Participating, on average, in no more than 20 minutes of physical activity on two or fewer days per week during the past six months
  • Willing to abstain from "as needed" medications for 7 days prior to each blood draw. "As needed" medications are defined as any medicine (prescription or over-the-counter) that is taken sporadically as needed for specific complaints rather than taken at regularly scheduled intervals (e.g., daily).

Exclusion Criteria:

  • Metastatic or recurrent breast cancer
  • Inability to ambulate without assistance
  • Unstable angina
  • New York Heart Association class II, III, or IV congestive heart failure
  • Uncontrolled asthma
  • Interstitial lung disease
  • Current use of steroids
  • Having been told by a physician to only do exercise prescribed by a physician
  • Dementia or organic brain syndrome
  • Schizophrenia or active psychosis
  • Connective tissue or rheumatologic disease [i.e., Systemic lupus erythematosus, rheumatoid arthritis, amyloidosis, Reiter's syndrome, psoriatic arthritis, mixed connective tissue disease, Sjögren's syndrome, progressive systemic sclerosis, CREST syndrome, polymyositis, dermatomyositis, vasculitis, polymyalgia rheumatic, temporal arteritis]
  • Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
  • Do not live or work less than 50 miles from the study site
  • Lack of transportation to the study site
  • Changes in usual medications expected during the study time period
  • Plan to move residence out of the local area during the 5 months of the study
  • Plan to travel out of the local area for vacation during the first 4 weeks of the intervention or plan to travel out of the local area for more than a week during the last 8 weeks of the intervention
  • Contraindication to participation in physical activity (i.e., moderate intensity walking and strength training with resistance bands)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
no physical activity intervention
Eksperimentel: Exercise intervention
3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands
3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands
Andre navne:
  • dyrke motion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
physical activity
Tidsramme: baseline and 3 months
The intervention group will be compared with the control group to examine the change in physical activity, before and after participation in a physical activity intervention. Participants are in the study for approximately 5 months. Assessments will be conducted at baseline, and following the 3 month exercise intervention.
baseline and 3 months
muscle strength
Tidsramme: baseline and 3 months
The intervention group will be compared with the control group to examine the change in muscle strength before and after participation in a physical activity intervention.
baseline and 3 months
fatigue
Tidsramme: baseline and 3 months
The intervention group will be compared with the control group to examine the change in fatigue before and after participation in a physical activity intervention.
baseline and 3 months
sleep dysfunction
Tidsramme: baseline and 3 months
The intervention group will be compared with the control group to examine the change in sleep dysfunction before and after participation in a physical activity intervention.
baseline and 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
inflammatory markers (serum cytokine levels)
Tidsramme: baseline and 3 months
The study will also examine whether changes in inflammatory markers mediate improvements in the outcome measures of muscle strength, fatigue, and sleep dysfunction. Blood samples with no potential for extraction of DNA will be collected.
baseline and 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2010

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

17. juni 2010

Først indsendt, der opfyldte QC-kriterier

17. juni 2010

Først opslået (Skøn)

22. juni 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ROG-SCCI-10-004-1
  • R21CA135017-01A2 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Brystkræft

Kliniske forsøg med 3 month physical activity intervention

3
Abonner