Frail Elderly SyndromeNCT03981965
FOCUS Guidelines and Adherence to Physical Activity in Ageing Women.
A study testing Physical activity in people with Frail Elderly Syndrome and Mood, run by University of Valencia at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 50 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome, Mood, Quality of Life
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2017to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community living postmenopausal women capable of performing the physical activity program and with ability to sign the informed consent.
Who cannot join
- Physical or psychological deficiencies incapacitating subjects to participate in the established physical program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of FOCUS Guidelines on 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.
Read the 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.
- Conditions
- Frail Elderly Syndrome, Mood, Quality of Life, Cognitive Decline, Social Interaction, Adherence, Patient
- Being tested
- Physical activity
- Keywords
- physical activity, adherence, Frailty, Mood, Socialisation, Quality of life, Cognition
- Medical subject headings
- Cognitive Dysfunction, Patient Compliance, Motor Activity, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Physical activity as described previously.
| Study group | Role | What they receive |
|---|---|---|
| Focus guidelines | Experimental | 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. Receives: Other: Physical activity |
| Active group | Active comparator | 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. Receives: Other: Physical activity |
| Inactive | No intervention | Women of similar clinical characteristic who did not participate in the PA program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
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.
Measured: 6 months
Cognitive function
Measures as per ACE-III questionnaire
Measured: 6 months
Mood status
Measures as per HAD questionnaire
Measured: 6 months
Social activities
Measures as per Saint Louis questionnaire
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start1 Apr 2017
- Primary completion1 Sep 2017
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación para la Investigación del Hospital Clínico de Valencia
- Responsible party
- Principal investigator, Antonio Cano Sanchez, University of Valencia
- Investigators
- Antonio Cano Sánchez, MD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981965
- Sponsor's protocol ID
- FOCUS_Valencia
- Status last verified
- Jun 2019
- First submitted
- 7 Jun 2019
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of FOCUS Guidelines on Adherence to Physical Activity in Ageing Women.
- ClinicalTrials.gov ID
- NCT03981965
- Acronym / sponsor ID
- FOCUS_Valencia
- Conditions
- Frail Elderly Syndrome, Mood, Quality of Life, Cognitive Decline, Social Interaction, Adherence, Patient
- Keywords
- physical activity, adherence, Frailty, Mood, Socialisation, Quality of life, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Fundación para la Investigación del Hospital Clínico de Valencia
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Focus guidelines | Experimental | Other: Physical activityParticipants 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. |
| Active group | Active comparator | Other: Physical activityParticipants 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. |
| Inactive | No intervention | –Women of similar clinical characteristic who did not participate in the PA program. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Community living postmenopausal women capable of performing the physical activity program and with ability to sign the informed consent.
Key exclusion criteria (1 listed)
- Physical or psychological deficiencies incapacitating subjects to participate in the established physical program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityPhysical activity as described previously. | Other | Active group, Focus guidelines |
Primary outcome
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.
6 secondary outcomes
Frailty: changes in frailty as assessed by the Fried index
Time frame: 6 months
Cognitive function
Time frame: 6 months
Mood status
Time frame: 6 months
Social activities
Time frame: 6 months
Psychological well-being as measured by the 52-item Ryff scale
Time frame: 6 months
Sleep quality, measured as per Athens Insomnia scale
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Cano Sánchez, MD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Frail Elderly Syndrome and Mood, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence: Level of adherence to the program as assessed by attendance to the physical activity sessions. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.