- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01707693
A Lifestyle Physical Activity Intervention for Older Sedentary Women (LPAW)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Arkansas
-
Little Rock, Arkansas, Verenigde Staten, 72205
- University of Arkansas for Medical Sciences
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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
|
Actieve vergelijker: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Accelerometer Vector Magnitude Counts
Tijdsspanne: 3 and 6 months
|
motion data counts calculated from three axes
|
3 and 6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Step of Counts (Per Day)
Tijdsspanne: 3 and 6 months
|
Number of steps that a person takes per day
|
3 and 6 months
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Self-Efficacy
Tijdsspanne: 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)
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Leanne L Lefler, PhD, University of Arkansas
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 135603
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Coronaire hartziekte
-
University Hospital TuebingenVoltooidHeart Assist-apparaatDuitsland
-
Carmel Medical CenterOnbekendPneumoperitoneum | Heart Output StoornisIsraël
-
Region SkaneAanmelden op uitnodigingHartfalen New York Heart Association (NYHA) Klasse II | Hartfalen New York Heart Association (NYHA) Klasse IIIZweden
-
University of ChicagoVoltooidHartfalen | Heart Assist-apparaat | HyponatremischVerenigde Staten
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University... en andere medewerkersNog niet aan het wervenHartfalen, systolisch | Hartfalen met verminderde ejectiefractie | Hartfalen New York Heart Association Klasse IV | Hartfalen New York Heart Association Klasse IIIPolen
-
Triple-Gene, LLCIntrexon Corporation; Precigen, IncVoltooidHart-en vaatziekten | Hartfalen | Heart-Assist-apparaatVerenigde Staten
-
Lawson Health Research InstituteVoltooidArteriosclerose van Arterial Coronary Artery Bypass GraftCanada
-
Deutsches Herzzentrum MuenchenVoltooidArteriosclerose van Arterial Coronary Artery Bypass GraftDuitsland
-
University of WashingtonAmerican Heart AssociationVoltooidHartfalen, congestief | Mitochondriale verandering | Hartfalen New York Heart Association Klasse IVVerenigde Staten
-
Novartis PharmaceuticalsVoltooidPatiënten die de behandelingsperiode van 12 maanden van de kernstudie met succes hebben afgerond (de Novo Heart-ontvangers) die geïnteresseerd waren om behandeld te worden met EC-MPS
Klinische onderzoeken op Lifestyle Physical Activity Intervention
-
University of California, San FranciscoVoltooidDarmkanker | EndeldarmkankerVerenigde Staten
-
Ming-Yuan ChihVoltooid
-
University of Alabama at BirminghamNational Cancer Institute (NCI)Werving
-
The Miriam HospitalOnbekendHartinfarct | Sedentaire levensstijl | Ischemische aanval, voorbijgaand | OefeningVerenigde Staten
-
Cairo UniversityAanmelden op uitnodiging
-
Istituto Ortopedico RizzoliUniversity of BolognaActief, niet wervendVerbeter de levenskwaliteitItalië
-
Istanbul Kültür UniversityIngetrokkenFysieke activiteitsniveau | Bewustwording van fysieke activiteit
-
St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences OrganizationVoltooid
-
Nigde Omer Halisdemir UniversityPamukkale UniversityVoltooid