FOCUS Guidelines and Adherence to Physical Activity in Ageing Women.

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Frail Elderly Syndrome; Cognitive Decline; Adherence, Patient; Mood; Social Interaction
• Intervention / Treatment: Other: Physical activity

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Hosp Clinico Universitario-INCLIVA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Physical activity; 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.	Other: Physical activity; Physical activity as described previously.
No Intervention: Inactive; Women of similar clinical characteristic who did not participate in the PA program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence: Level of adherence to the program as assessed by attendance to the physical activity sessions.	Attendance will be measured as a percentage of the total number of sessions.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty: changes in frailty as assessed by the Fried index	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	Measures as per ACE-III questionnaire	6 months
Mood status	Measures as per HAD questionnaire	6 months
Social activities	Measures as per Saint Louis questionnaire	6 months
Psychological well-being as measured by the 52-item Ryff scale	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	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

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Fundación para la Investigación del Hospital Clínico de Valencia
• Investigators: Principal Investigator: Antonio Cano Sánchez, MD, University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: physical activity; Quality of life; adherence; Cognition; Frailty; Mood; Socialisation
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: FOCUS_Valencia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No