FOCUS Guidelines and Adherence to Physical Activity in Ageing Women.

NCT03981965 | Completed

• 1 other identifier: FOCUS_Valencia
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (6)

• Frailty: changes in frailty as assessed by the Fried index

  6 months

• Cognitive function

  6 months

• Mood status

  6 months

• Social activities

  6 months

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

  6 months

Study Arms (3)

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.

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.

Other: Physical activity

Inactive

NO INTERVENTION

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

Interventions

Physical activity OTHER

Physical activity as described previously.

Active group; Focus guidelines

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community living postmenopausal women capable of performing the physical activity program and with ability to sign the informed consent.

You may not qualify if:

• Physical or psychological deficiencies incapacitating subjects to participate in the established physical program.

Sponsors & Collaborators

• University of Valencia: lead
• Fundación para la Investigación del Hospital Clínico de Valencia: collaborator

Study Sites (1)

Hosp Clinico Universitario-INCLIVA

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Patient Compliance; Motor Activity; Frailty

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Antonio Cano Sánchez, MD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Obstetrics and Gynecology

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 11, 2019
• Study Start: April 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: March 30, 2018
• Last Updated: June 12, 2019

Record last verified: 2019-06

Locations

ES (1)