FOCUS Guidelines and Adherence to Physical Activity in Ageing Women.
Impact of FOCUS Guidelines on Adherence to Physical Activity in Ageing Women.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The objectives of the study consisted of assessing i) whether the use of the Guidelines derived from the European project FOCUS had an effect on the adherence to a physical activity (PA) program (primary objective), and ii) the effect of the program, which included 2 h/week of PA, on a group of dimensions related with general health, frailty, psycho-cognitive parameters, and quality of life (QoL) (secondary objectives).
The study comprised 24 weeks in which a group of 90 postmenopausal women were randomised to three arms, two in which participants were performing PA, and one control (no intervention).
The first PA group followed the FOCUS guidelines, in which women received monthly health talks and had an internet mailbox to facilitate contact with health professionals.
The PA program consisted of a twice per week 1-hour session along 24 weeks. This period was divided into two parts, a first supervised phase in which women followed group sessions under direct supervision of a monitor, and a second period in which the groups of women followed the same exercise pattern, but autonomously. A mobile phone support system (social network whatsapp) was used for inter-connection and mutual support during the autonomous period. Assessments were performed at baseline and then at 12 weeks and 24 weeks, representing the completion of the supervised and the autonomous periods, respectively.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Valencia, Spanje, 46010
- Hosp Clinico Universitario-INCLIVA
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
Community living postmenopausal women capable of performing the physical activity program and with ability to sign the informed consent.
Exclusion Criteria:
Physical or psychological deficiencies incapacitating subjects to participate in the established physical program.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Focus guidelines
Participants enrolled in a 2-phase physical activity program divided in 2 phases as described above. Briefly, The activity consisted in a 1-h set of exercises twice per week. The first 12-week phase was performed in group under the direct supervision of a health monitor. The second 12-week phase was autonomous, and consisted of the same physical performance while maintaining virtual link through a social network based on the mobile phone. The FOCUS guidelines provided 2 features, the participation in monthly health talks provided by the principal investigator and the availability of a virtual mailbox to transmit any comment or suggestion. |
Physical activity as described previously.
|
|
Actieve vergelijker: Active group
Participants enrolled in a 2-phase physical activity program divided into 2 phases as described above.
This group lacked the monthly talks and did not have access to the virtual mailbox.
|
Physical activity as described previously.
|
|
Geen tussenkomst: Inactive
Women of similar clinical characteristic who did not participate in the PA program.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Adherence: Level of adherence to the program as assessed by attendance to the physical activity sessions.
Tijdsspanne: 6 months
|
Attendance will be measured as a percentage of the total number of sessions.
|
6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Frailty: changes in frailty as assessed by the Fried index
Tijdsspanne: 6 months
|
Changes in frailty as assessed by the Fried index, which has 5 dimensions and describes a robust state (negative for all the three criteria) in addition to the pre-frail (positive for 1 or 2 criteria) and frail (positive at least in 3 criteria) status.
|
6 months
|
|
Cognitive function
Tijdsspanne: 6 months
|
Measures as per ACE-III questionnaire
|
6 months
|
|
Mood status
Tijdsspanne: 6 months
|
Measures as per HAD questionnaire
|
6 months
|
|
Social activities
Tijdsspanne: 6 months
|
Measures as per Saint Louis questionnaire
|
6 months
|
|
Psychological well-being as measured by the 52-item Ryff scale
Tijdsspanne: 6 months
|
The Ryff scale includes 52 items designed to measure six constructs of psychological well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance.
Higher total scores indicate higher psychological well-being.
Respondents rate statements on a scale of 1 to 6, where 1 indicates strong disagreement and 6 indicates strong agreement.
|
6 months
|
|
Sleep quality, measured as per Athens Insomnia scale
Tijdsspanne: 6 months
|
The Athens scale aims at assessing the insomnia symptoms in individuals with sleep disorders.
The scale measures 8 factors, which are intended to measure nocturnal sleep (5 factors) and daytime sleep-related disorders.
Factors are rated from 0 till 3 and the cumulative score gives the final outcome.
A cut-off score of 6 or higher is considered equivalent to the diagnosis of insomnia.
|
6 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Antonio Cano Sánchez, MD, University of Valencia
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
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
- FOCUS_Valencia
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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 .