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FOCUS Guidelines and Adherence to Physical Activity in Ageing Women.

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ClinicalTrials.gov Identifier: NCT03981965
Recruitment Status : Completed
First Posted : June 11, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Fundación para la Investigación del Hospital Clínico de Valencia
Information provided by (Responsible Party):
Antonio Cano Sanchez, University of Valencia

Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 11, 2019
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE April 1, 2017
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
Adherence [ Time Frame: 6 months ]
Level of adherence to the program as assessed by attendance to the physical activity sessions
Change History Complete list of historical versions of study NCT03981965 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • 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.
  • Cognitive function [ Time Frame: 6 months ]
    Measures as per ACE-III questionnaire
  • Mood status [ Time Frame: 6 months ]
    Measures as per HAD questionnaire
  • Social activities [ Time Frame: 6 months ]
    Measures as per Saint Louis questionnaire
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Frailty [ Time Frame: 6 months ]
    Changes in frailty as assessed by the Fried index
  • Cognitive function [ Time Frame: 6 months ]
    Measures as per ACE-III questionnaire
  • Mood status [ Time Frame: 6 months ]
    Measures as per HAD questionnaire
  • Social activities [ Time Frame: 6 months ]
    Measures as per Saint Louis questionnaire
  • Quality of life with Ryff scale [ Time Frame: 6 months ]
    Measures as per Ryff scale
  • Sleep quality [ Time Frame: 6 months ]
    Measures as per Athens Insomnia scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FOCUS Guidelines and Adherence to Physical Activity in Ageing Women.
Official Title  ICMJE Impact of FOCUS Guidelines on Adherence to Physical Activity in Ageing Women.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Frail Elderly Syndrome
  • Mood
  • Quality of Life
  • Cognitive Decline
  • Social Interaction
  • Adherence, Patient
Intervention  ICMJE Other: Physical activity
Physical activity as described previously.
Study Arms  ICMJE
  • 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.

    Intervention: Other: Physical activity
  • 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.
    Intervention: Other: Physical activity
  • No Intervention: Inactive
    Women of similar clinical characteristic who did not participate in the PA program.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2019)
90
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 30, 2018
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03981965
Other Study ID Numbers  ICMJE FOCUS_Valencia
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Antonio Cano Sanchez, University of Valencia
Study Sponsor  ICMJE University of Valencia
Collaborators  ICMJE Fundación para la Investigación del Hospital Clínico de Valencia
Investigators  ICMJE
Principal Investigator: Antonio Cano Sánchez, MD University of Valencia
PRS Account University of Valencia
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP