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Effectiveness of Group Walking Sessions for Increasing Activity in People With Peripheral Arterial Disease (The Group Oriented Arterial Leg Study [GOALS])

tiistai 27. lokakuuta 2015 päivittänyt: Mary McDermott, Northwestern University

Increasing Activity in Peripheral Arterial Disease

Lower extremity peripheral arterial disease (PAD) is a disease in which fatty build-up, or plaque, accumulates in the arteries of the legs. People with lower extremity PAD often experience leg pain while walking, which is caused by reduced blood flow to the legs. Regular walking has significant benefits for people with blood flow problems in their legs, but previous studies have shown that most men and women with PAD do not walk for exercise on a regular basis. A group home-based walking program may help people with PAD to walk more often and improve their lower extremity functioning. This study will evaluate the effectiveness of a home-based group mediated cognitive behavioral (GMCB) exercise program in helping people with lower extremity PAD to increase their walking frequency and improve their lower leg functioning.

Tutkimuksen yleiskatsaus

Yksityiskohtainen kuvaus

Lower extremity PAD affects between 10% and 15% of people over the age of 65. A person's risk for PAD increases with age but can also be raised by smoking or having diabetes, high blood pressure, high cholesterol, or heart disease. PAD symptoms may include leg pain, foot or toe wounds, and a noticeably lower temperature in the lower legs than in the rest of the body. The specific functional impairments caused by PAD symptoms are associated with increased risks of disability, nursing home placement, mobility loss, hospitalization, and mortality. Supervised exercise rehabilitation programs have been shown to improve walking ability in people with PAD. However, few people with PAD have access to supervised exercise rehabilitation programs because of costs and difficulty traveling to the exercise facility. Home-based exercise programs may be more beneficial than supervised programs in improving lower extremity functioning in people with PAD, but more information is needed to support the effectiveness of at-home rehabilitation. This study will compare the effectiveness of a home-based GMCB exercise program versus general health education sessions in helping people with lower extremity PAD to increase their walking frequency and improve their lower leg functioning.

Participation in this study will last 12 months. The primary outcome will be measured at 6 month follow-up. All participants will undergo a baseline 6-minute walk test on a treadmill and an electrocardiogram (ECG). They will also provide information on their physical activity levels. Participants will then be assigned randomly to receive GMCB sessions or health education sessions. Both groups will attend weekly sessions of their assigned treatment for a 6 month period. During the GMCB sessions, participants will be asked to exercise by walking around a track. There will also be a group discussion, led by a facilitator, who will help participants find ways to increase the frequency of their walking exercise at home. Each GMCB session will last approximately 60 to 75 minutes. Health education sessions will last 60 minutes and will cover health-related topics.

After completing approximately 6 months of treatment, participants in both groups will be telephoned regularly by a study coordinator: they will receive telephone calls every other week during Months 6 to 9 of follow-up and monthly during Months 9 to 12 of follow-up. Participants will be asked to return for follow-up testing at Month 6 and Month 12; outcomes measured at Month 6 are highest priority.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

194

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

    • Illinois
      • Chicago, Illinois, Yhdysvallat, 60611
        • Northwestern University Feinberg School of Medicine

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

25 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  • Have PAD
  • Potential participants with a resting ABI greater than or equal to 0.91 and less than or equal to 1.00 at their baseline visit will be eligible if their ABI drops by at least 20% after the heel-rise test. Potential participants with a resting baseline ABI greater than 0.91 who do not meet criteria for inclusion based on the heel-rise test can be eligible if they have data from a certified non-invasive vascular laboratory that demonstrates presence of lower extremity ischemia. However, more evidence than an abnormal PVR from the non-invasive vascular laboratory is required (for example, a toe brachial index pressure less than 0.60). Finally, potential participants who do not meet the above criteria for inclusion will be eligible if they have an angiogram demonstrating greater than 50% stenosis on one or more lower extremity arterial vessels.

Exclusion Criteria:

  • Below or above knee amputation
  • Wheelchair confinement
  • Uses a walking aid other than a cane (e.g., walker)
  • Unable to return to the medical center at the required visit frequency
  • Greater than Class II New York Heart Association heart failure or angina (symptoms at rest or with minimal exertion)
  • Any increase in angina pectoris symptoms during the 6 months before study entry or angina at rest
  • Presence of a foot ulcer
  • Lower extremity revascularization or major orthopedic surgery during the 3 months before study entry
  • Heart attack or coronary artery bypass grafting during the 3 months before study entry
  • Major medical illnesses, including treatment for cancer (except non-melanoma skin cancer) during the 12 months before study entry
  • Planned lower extremity revascularization within the 12 months after study entry
  • Current participation in another clinical trial
  • Walking for exercise at a level comparable to that targeted in the study's intervention
  • Completion of a cardiac rehabilitation program within 3 months before study entry
  • Coronary ischemia during exercise, defined as ST segment depression greater than 1 mm during the baseline exercise treadmill test, with or without associated chest discomfort
  • Left-bundle branch block or significant ST-T wave changes on the baseline ECG without a perfusion stress test, demonstrating no reversible ischemia within the 3 months before study entry
  • Stopping during the treadmill exercise stress test because of chest pain, shortness of breath, hip or knee arthritis. These individuals will be interviewed by the principal investigator and will be excluded only if it is determined that their walking performance (based in part on the treadmill test) is limited by a comorbidity other than leg ischemia.
  • Unable to walk at least 50 feet without stopping during the 6-minute walk test
  • Stopping during the 6-minute walk test for symptoms other than ischemic leg symptoms
  • Mini-Mental Status Examination (MMSE) score of less than 23 or psychiatric illness
  • Failure to complete a study run-in period
  • Parkinson's disease
  • Requires oxygen with exertion.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Yksittäinen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 1
Participants will receive treatment with group mediated cognitive behavioral sessions.
GMCB will include weekly group exercise sessions, lasting approximately 60 to 75 minutes each for a 6 month period. During these sessions, participants will be asked to exercise by walking around a track. There will also be a group discussion, led by a facilitator, who will help participants find ways to increase the frequency of their walking exercise at home. After completing the GMCB sessions, which will last about 6 months, participants will be telephoned regularly by a study coordinator for another 6 months.
Active Comparator: 2
Participants will receive treatment with health education sessions.
Health education will include weekly educational sessions on a health-related topic, lasting approximately 60 minutes each. After completing the health education sessions, which will last about 6 months, participants will be telephoned regularly by a study coordinator for another 6 months.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Aikaikkuna
6-minute walk test at 6 month follow-up
Aikaikkuna: Measured at baseline and Month 6 follow-up
Measured at baseline and Month 6 follow-up

Toissijaiset tulostoimenpiteet

Tulosmittaus
Aikaikkuna
Treadmill walking performance
Aikaikkuna: Measured at baseline and Month 6 follow-up
Measured at baseline and Month 6 follow-up
Health-related quality of life measures
Aikaikkuna: Measured at baseline, Month 6, and Month 12 follow-up
Measured at baseline, Month 6, and Month 12 follow-up
Physical activity levels
Aikaikkuna: Measured at baseline, Month 6, and Month 12 follow-up
Measured at baseline, Month 6, and Month 12 follow-up
6-minute walk test at Month 12 follow-up
Aikaikkuna: Measured at Month 12 follow-up
Measured at Month 12 follow-up

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Tutkijat

  • Päätutkija: Mary M. McDermott, MD, Northwestern University

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Sunnuntai 1. kesäkuuta 2008

Ensisijainen valmistuminen (Todellinen)

Lauantai 1. joulukuuta 2012

Opintojen valmistuminen (Todellinen)

Keskiviikko 1. toukokuuta 2013

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 5. kesäkuuta 2008

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 5. kesäkuuta 2008

Ensimmäinen Lähetetty (Arvio)

Maanantai 9. kesäkuuta 2008

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Torstai 29. lokakuuta 2015

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 27. lokakuuta 2015

Viimeksi vahvistettu

Torstai 1. lokakuuta 2015

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muut tutkimustunnusnumerot

  • 586
  • R01HL088589-01 (Yhdysvaltain NIH-apuraha/sopimus)
  • HL088589-01

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