Adherence, Patient, Cognitive Decline, Frail Elderly Syndrome, Mood, Quality of Life, Social Interaction
Conditions
Keywords
physical activity, adherence, Frailty, Mood, Socialisation, Quality of life, Cognition
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.
Interventions
OTHERPhysical activity
Physical activity as described previously.
Sponsors
Fundación para la Investigación del Hospital Clínico de Valencia
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function | 6 months | Measures as per ACE-III questionnaire |
| Mood status | 6 months | Measures as per HAD questionnaire |
| 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. |
| 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. |
| Social activities | 6 months | Measures as per Saint Louis questionnaire |
Countries
Spain
Outcome results
None listed