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FOCUS Guidelines and Adherence to Physical Activity in Ageing Women.

Primary Purpose

Frail Elderly Syndrome, Mood, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical activity
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frail Elderly Syndrome focused on measuring physical activity, adherence, Frailty, Mood, Socialisation, Quality of life, Cognition

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Hosp Clinico Universitario-INCLIVA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Focus guidelines

Active group

Inactive

Arm Description

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.

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.

Women of similar clinical characteristic who did not participate in the PA program.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Cognitive function
Measures as per ACE-III questionnaire
Mood status
Measures as per HAD questionnaire
Social activities
Measures as per Saint Louis questionnaire
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.
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.

Full Information

First Posted
June 7, 2019
Last Updated
June 10, 2019
Sponsor
University of Valencia
Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT03981965
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome, Mood, Quality of Life, Cognitive Decline, Social Interaction, Adherence, Patient
Keywords
physical activity, adherence, Frailty, Mood, Socialisation, Quality of life, Cognition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Focus guidelines
Arm Type
Experimental
Arm Description
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.
Arm Title
Active group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Inactive
Arm Type
No Intervention
Arm Description
Women of similar clinical characteristic who did not participate in the PA program.
Intervention Type
Other
Intervention Name(s)
Physical activity
Intervention Description
Physical activity as described previously.
Primary Outcome Measure Information:
Title
Adherence: Level of adherence to the program as assessed by attendance to the physical activity sessions.
Description
Attendance will be measured as a percentage of the total number of sessions.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Frailty: changes in frailty as assessed by the Fried index
Description
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.
Time Frame
6 months
Title
Cognitive function
Description
Measures as per ACE-III questionnaire
Time Frame
6 months
Title
Mood status
Description
Measures as per HAD questionnaire
Time Frame
6 months
Title
Social activities
Description
Measures as per Saint Louis questionnaire
Time Frame
6 months
Title
Psychological well-being as measured by the 52-item Ryff scale
Description
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.
Time Frame
6 months
Title
Sleep quality, measured as per Athens Insomnia scale
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Cano Sánchez, MD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hosp Clinico Universitario-INCLIVA
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

FOCUS Guidelines and Adherence to Physical Activity in Ageing Women.

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