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Completed

NCT Number: NCT03981965

FOCUS Guidelines and 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical activity

Other

Physical activity as described previously.

Primary outcomes

  1. Adherence: Level of adherence to the program as assessed by attendance to the physical activity sessions.

    Time frame: 6 months

    Attendance will be measured as a percentage of the total number of sessions.

Secondary outcomes

  1. Frailty: changes in frailty as assessed by the Fried index

    Time frame: 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.

  2. Cognitive function

    Time frame: 6 months

    Measures as per ACE-III questionnaire

  3. Mood status

    Time frame: 6 months

    Measures as per HAD questionnaire

  4. Social activities

    Time frame: 6 months

    Measures as per Saint Louis questionnaire

  5. Psychological well-being as measured by the 52-item Ryff scale

    Time frame: 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.

  6. Sleep quality, measured as per Athens Insomnia scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Fundación para la Investigación del Hospital Clínico de Valencia

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jun 11, 2019
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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