FOCUS Guidelines and Adherence to Physical Activity in Ageing Women.

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03981965
• Other study ID #: FOCUS_Valencia
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: June 2019
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 30, 2018
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Physical activity
Physical activity as described previously.

Locations

Country	Name	City	State
Spain	Hosp Clinico Universitario-INCLIVA	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Fundación para la Investigación del Hospital Clínico de Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cognitive function	Measures as per ACE-III questionnaire	6 months
Secondary	Mood status	Measures as per HAD questionnaire	6 months
Secondary	Social activities	Measures as per Saint Louis questionnaire	6 months
Secondary	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
Secondary	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