- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01707693
A Lifestyle Physical Activity Intervention for Older Sedentary Women (LPAW)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Over 98% of older women do not meet national guidelines for physical activity (PA). There is clear evidence that a physically active lifestyle reduces the human and economic cost of heart disease in a dose-response relationship; but current efforts to increase long-term PA in older women are inadequate. The aims of this proposed research are to: 1) determine the feasibility of using an individually tailored motivational counseling intervention method to promote lifestyle physical activity (LPA) in older sedentary women; 2) examine intervention effects by comparing baseline to outcome measures at 3 and 6 months in treatment and information/attention comparison groups; and 3) explore stage of behavior change and self-efficacy and their relationship to LPA, along with functional health.
This will be a single blinded randomized controlled study of sedentary women aged 60 years and older. We will replace "structured aerobic exercise" with lifestyle physical activity (LPA), i.e., self-selected activities performed daily in a purposeful manner to meet the national PA guidelines. A total of 120 older women who are ambulatory and cognitively intact will be recruited from a senior health clinic and randomized to receive either the motivational LPA intervention or information/attention. Women will be assessed at baseline, 3 and 6 months. The theoretically based behavioral intervention is derived from the Transtheoretical Model and other evidence-based physical activity research. We will use a Motivational Interviewing counseling technique delivered by a social worker to individually tailor the LPA intervention to participant preferences, taking into consideration their functional ability and need for information, readiness to change, and self-efficacy. Outcomes of the LPA intervention sessions will include tailored goals and an LPA plan. Intervention participants will also receive the newly developed NIA "Exercise & You" LPA informational booklet with companion digital video disc (DVD) as well as motivational coaching via telephone calls, tapering in frequency for 6 months. The control group will receive the NIA LPA booklet with DVD and attention telephone calls. We will assess changes from baseline in LPA (primary outcome), readiness to change, self-efficacy and function (secondary outcomes) and examine the associations between primary and secondary outcomes in both groups. The allied disciplines of Nursing, Gerontology, Social Work, and Medicine will collaborate to promote PA and cardiovascular health of older women. Undergraduate and graduate student research assistants will contribute to this project. This research has the potential to increase PA of sedentary older women and reduce coronary heart disease risks. If we could increase physical activity in our rapidly growing older population -even modestly, we could make a significant impact to the health of our nation.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Arkansas
-
Little Rock, Arkansas, Förenta staterna, 72205
- University of Arkansas for Medical Sciences
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- women > 60 years of age who are Senior Health clinic patients
- health care provider's approval to participate
- ability to speak/read English
- access to a telephone
Exclusion Criteria:
- report participation in a regular physical activity program
- report an unresolved acute illness, such as pneumonia or flu
- fail screening for capacity to provide informed consent
- fail a simple functional screen or are currently nonambulatory
- are unable to complete activities of daily living
- have uncorrectable severe hearing or vision deficits
- have a history of falls in the past 3 months
- have other unforeseen pathology that precludes safe participation
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Lifestyle Physical Activity Intervention
the women will be randomized to either the LPA Intervention or Information/Attention Comparison groups using a permuted block randomization scheme.
Participants in both groups will be followed longitudinally with repeated assessments of LPA (accelerometer & LPA diary), stage of change, and self-efficacy at baseline and 3 and 6 months; and functional health and well-being (SF36) at baseline and 6 months.
|
Physical Activity Information given plus Behavioral counseling using motivational interviewing & follow-up
|
Aktiv komparator: Information/Attention Comparison
the women will be randomized to either the LPA Intervention or Information/Attention Comparison groups using a permuted block randomization scheme.
Participants in both groups will be followed longitudinally with repeated assessments of LPA (accelerometer & LPA diary), stage of change, and self-efficacy at baseline and 3 and 6 months; and functional health and well-being (SF36) at baseline and 6 months.
|
Physical Activity information given & follow-up, no behavioral counseling
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Accelerometer Vector Magnitude Counts
Tidsram: 3 and 6 months
|
motion data counts calculated from three axes
|
3 and 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Step of Counts (Per Day)
Tidsram: 3 and 6 months
|
Number of steps that a person takes per day
|
3 and 6 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Self-Efficacy
Tidsram: Baseline, 3mths, 6mths
|
Self-Efficacy for Exercise Scale used to estimate the strength of self-efficacy beliefs; The tool contains 9 items with an 0-10 answer format from "Not Confident to Very Confident" and summed numerical ratings; higher scores indicate greater self-efficacy.
|
Baseline, 3mths, 6mths
|
Stage of Change (SOC)
Tidsram: Baseline, 3 and 6 months
|
Exercise Stage of Change information on how ready an individual is to make a change related to participating in physical activity.
It consists of four questions (Yes or No response format) in which the individual is rated on current stage of change
|
Baseline, 3 and 6 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Leanne L Lefler, PhD, University of Arkansas
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 135603
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Kranskärlssjukdom
-
IRCCS Policlinico S. DonatoRekryteringAnomalous aortic origin of the coronary artery (AAOCA)Italien
-
Biotronik AGAvslutadde Novo Lesions in Native coronary arteriesNederländerna, Schweiz, Tyskland, Belgien
-
Region SkaneAnmälan via inbjudanHjärtsvikt New York Heart Association (NYHA) klass II | Hjärtsvikt New York Heart Association (NYHA) klass IIISverige
-
Osaka General Medical CenterAvslutadEmergent coronary procedurJapan
-
Taichung Veterans General HospitalRekryteringKontinuerlig Fetal Heart Beat Monitor och analys efter Spinal AnestesiTaiwan
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan... och andra samarbetspartnersHar inte rekryterat ännuHjärtsvikt, systolisk | Hjärtsvikt Med Minskad Ejection Fraktion | Hjärtsvikt New York Heart Association Klass IV | Hjärtsvikt New York Heart Association Klass IIIPolen
-
University of WashingtonAmerican Heart AssociationAvslutadHjärtsvikt, Kongestiv | Mitokondriell förändring | Hjärtsvikt New York Heart Association Klass IVFörenta staterna
-
Claudia SpiesAvslutadOmskärelse, Meatotomy eller Distal Coronary Correction of HypospadiaTyskland
-
Novartis PharmaceuticalsAvslutadPatienter som framgångsrikt slutfört den 12 månader långa behandlingsperioden i kärnstudien (de Novo Heart Recipients) som var intresserade av att bli behandlad med EC-MPS
-
University Hospital, GasthuisbergOkändTransient Left Ventricular Ballooning SyndromeBelgien
Kliniska prövningar på Lifestyle Physical Activity Intervention
-
Jackie DziewiorAvslutadHypertensiv sjukdom vid graviditetFörenta staterna
-
The Miriam HospitalOkändStroke | Stillasittande livsstil | Ischemisk attack, övergående | TräningFörenta staterna
-
Hospices Civils de LyonAvslutad
-
Centre Hospitalier Universitaire de BesanconRekrytering
-
Wake Forest University Health SciencesNational Heart, Lung, and Blood Institute (NHLBI)AvslutadFysisk aktivitetFörenta staterna
-
Centre Hospitalier Universitaire de Saint EtienneNational Cancer Institute, FranceAvslutadCancer ProstataFrankrike
-
Fatih Sultan Mehmet Training and Research HospitalAktiv, inte rekryterande
-
Duke UniversityVerizon WirelessAvslutadPerifer artärsjukdomFörenta staterna
-
Cairo UniversityAnmälan via inbjudan