NCT03981965

FOCUS Guidelines and Adherence to Physical Activity in Ageing Women.

Impact of FOCUS Guidelines on Adherence to Physical Activity in Ageing Women.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: University of Valencia · Academic / Other
• Sex: Female
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The study aimed at assessing whether the guidelines from the European project FOCUS had an effect on adherence to a physical activity program in older women. The program consisted of two 12-week periods, in which women followed a set of pre-specified exercises (1 hour, twice per week). The first period was supervised by a monitor while the second was autonomous. Support groups, in which the contact between participants was established through information and communication technologies (social-network through the mobile phone), were set up to maintain engagement between participants. Women were randomized to three arms consisting of 2 intervention groups, with and without the FOCUS guidelines, and a sedentary control. Secondary outcomes included a battery of dimensions affecting physical performance, psychological status, and quality of life.

Detailed description

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.

Conditions

• Frail Elderly Syndrome
• Mood
• Quality of Life
• Cognitive Decline
• Social Interaction
• Adherence, Patient

Interventions

Type	Name	Description
OTHER	Physical activity	Physical activity as described previously.

Timeline

• Start date: 2017-04-01
• Primary completion: 2017-09-01
• Completion: 2018-03-30
• First posted: 2019-06-11
• Last updated: 2019-06-12

Locations

1 site across 1 country: Spain