Clinical trial NCT03981965: FOCUS Guidelines and Adherence to Physical Activity in Ageing Women.
Official title: Impact of FOCUS Guidelines on Adherence to Physical Activity in Ageing Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Mood
Quality of Life
Cognitive Decline
Social Interaction
Adherence, Patient
Keywords: physical activity
adherence
Frailty
Mood
Socialisation
Quality of life
Cognition
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Fundación para la Investigación del Hospital Clínico de Valencia
First posted: 2019-06-11
Enrollment: 90
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups were designed for a 24 week duration of the study. Two groups performed physical activity in two 12-week periods. A health professional acted as a supervisor during the first period. The second period was autonomous, with women providing mutual support through whatsapp, a mobile phone based social network. The first group followed the guidelines emanated from the FOCUS European project. The third group was an inactive control.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence: Level of adherence to the program as assessed by attendance to the physical activity sessions.
timeFrame: 6 months
Secondary outcomes:
measure: Frailty: changes in frailty as assessed by the Fried index
timeFrame: 6 months
measure: Cognitive function
timeFrame: 6 months
measure: Mood status
timeFrame: 6 months
measure: Social activities
timeFrame: 6 months
measure: Psychological well-being as measured by the 52-item Ryff scale
timeFrame: 6 months
measure: Sleep quality, measured as per Athens Insomnia scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hosp Clinico Universitario-INCLIVA
Study officials:
affiliation: University of Valencia
name: Antonio Cano Sánchez, MD
role: PRINCIPAL_INVESTIGATOR
References: