NCT04732078

Brief Summary

Today's world is characterized among other things by a progressive increase in the aging population, due to a decrease in the birth rate and an increase in life expectancy. In developed countries, the number of older people is increasing, largely due to significant advances in health sciences and new life habits. The aim of this study is to describe an active population over 60 years old, which complies with the concept of successful aging, in order to know its characteristics both at a physical and mental health level and to be able to make recommendations from physiotherapy. Active people over 60 years of age recruited from two associations (Amics de la Nau Gran, and Hogares) from the city of Valencia, Spain will be part of the study. Pain was assessed using the Visual Analogue Scale, the level of physical activity performed using the IPAQ questionnaire, quality of life using the SF-12v2, sleep quality using the Pittsburg questionnaire, and mood using the depression scale and Goldberg's anxiety, as well as functional tests to assess respiratory status.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

February 4, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2021

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

January 25, 2021

Last Update Submit

February 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Health status

    By the SF-12 Health Questionnaire (version 2). This questionnaire is an abbreviated version of the SF-36, with an approximate duration of 2 minutes and made up of 12 different items that address different physical and mental aspects of the person (physical role, emotional role, social role, physical function, mental health , limiting pain, vitality and general health). It uses the Likert scale and each item has different response options ranging from 3 to 6. The maximum score that can be obtained is 100 points.

    day 1

Secondary Outcomes (7)

  • Intensity of Pain

    day 1

  • Mental State

    day 1

  • Level of Physical Activity

    day 1

  • Sleep quality

    day 1

  • Mood State

    day 1

  • +2 more secondary outcomes

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Active people over 60 years of age recruited from two associations from the city of Valencia, Spain will be part of the study.

You may qualify if:

  • That they obtain in the IPAQ questionnaire on physical activity values belonging to category 2 (moderate level of physical activity) or 3 (high level of physical activity), that is, belonging to the group of ACTIVE people.
  • That they are suitable in the Lobo Mini Cognitive Exam, with a score greater than or equal to 24 (with an adequate level of cognition, necessary to carry out the study).
  • Meet the characteristics of "successful aging" (not having suffered in the last two years stroke or cerebrovascular accident, arteriosclerosis, angina, acute myocardial infarction, cancer, diabetes, chronic respiratory disease, chronic cardiovascular disease, neurological disease or psychological alteration).

You may not qualify if:

  • Under 60 years not active according to the IPAQ
  • Score less than 24 in the Lobo Mini Cognitive Exam (MEC),
  • Those people who due to their physical condition cannot carry out the tests with guarantees of safety.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gemma Victoria Espí-López

Valencia, 46010, Spain

Location

Study Officials

  • Gemma V Espí López, Dr

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 1, 2021

Study Start

February 4, 2021

Primary Completion

March 30, 2021

Study Completion

April 17, 2021

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations