FOCUS Guidelines and Adherence to Physical Activity in Ageing Women.

Sponsor

University of Valencia (Other)

Overall Status

Completed

CT.gov ID

NCT03981965

Collaborator

Fundación para la Investigación del Hospital Clínico de Valencia (Other)

Enrollment

Location

Arms

11.9

Actual Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Frail Elderly Syndrome Mood Quality of Life Cognitive Decline Social Interaction Adherence, Patient	Other: Physical activity	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 1, 2017

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Mar 30, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Adherence: Level of adherence to the program as assessed by attendance to the physical activity sessions. [6 months]
Attendance will be measured as a percentage of the total number of sessions.

Secondary Outcome Measures

Frailty: changes in frailty as assessed by the Fried index [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.
Cognitive function [6 months]
Measures as per ACE-III questionnaire
Mood status [6 months]
Measures as per HAD questionnaire
Social activities [6 months]
Measures as per Saint Louis questionnaire
Psychological well-being as measured by the 52-item Ryff scale [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.
Sleep quality, measured as per Athens Insomnia scale [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.