FOCUS Guidelines and Adherence to Physical Activity in Ageing Women.
Impact of FOCUS Guidelines on Adherence to Physical Activity in Ageing Women.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Valencia, Espanja, 46010
- Hosp Clinico Universitario-INCLIVA
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Active Comparator: 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.
|
|
Ei väliintuloa: Inactive
Women of similar clinical characteristic who did not participate in the PA program.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Adherence: Level of adherence to the program as assessed by attendance to the physical activity sessions.
Aikaikkuna: 6 months
|
Attendance will be measured as a percentage of the total number of sessions.
|
6 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Frailty: changes in frailty as assessed by the Fried index
Aikaikkuna: 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
Aikaikkuna: 6 months
|
Measures as per ACE-III questionnaire
|
6 months
|
|
Mood status
Aikaikkuna: 6 months
|
Measures as per HAD questionnaire
|
6 months
|
|
Social activities
Aikaikkuna: 6 months
|
Measures as per Saint Louis questionnaire
|
6 months
|
|
Psychological well-being as measured by the 52-item Ryff scale
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Antonio Cano Sánchez, MD, University of Valencia
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- FOCUS_Valencia
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .