ClinicalTrials.gg
RecruitingNCT06842849Updated Sep 11, 2026

Impact of a Physical Exercise Program in a Rural Area

An interventional study of Exercise program in Old Age; Debility, sponsored by University of Valencia. Recruiting at 1 site in Spain. Open to participants aged 59 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by University of Valencia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Ages
59 Years and older
Sex
All
01

Study summary

With this work we want to assess whether there are differences in the amount of physical activity per week, measured by accelerometry in 3 groups of subjects, where one group (G1) has been carrying out a PA program called "Enguera Sé Saludable" for a year. another group (G2) newly introduced to the same exercise program, and a control group (G3) that does not carry out an exercise program but declared itself active.

Read the detailed description

Active aging, according to the World Health Organization (WHO), involves making the most of everything that contributes to physical, mental and social well-being throughout life, thus promoting improved quality of life, functionality and longevity in the most advanced stages of life, seeking to minimize disability. To achieve active aging, older people must remain active in all aspects: physical, social and mental. For this reason, the WHO recommends that older adults engage in moderate to vigorous physical activity (MVPA) of 150 minutes a week The objetive, To assess whether there are differences in the amount of MVPA per week, measured by accelerometry in 3 groups of subjects, where one group (G1) had been carrying out a PA program called "Enguera Sé Saludable" for a year, another group (G2 ) newly inserted into the same exercise program, and a control group (G3) that did not carry out an exercise program but declared itself active.

Analytical quasi-experimental study, with 3 groups. A group (G1) over 59 years of age, of both sexes who have been doing PA since the year before the start of the study, within the "Enguera Be Healthy" Program in the municipality of Enguera. Another group (G2) of both sexes, newly enrolled in the same exercise program over 59 years of age. A control group (G3) of 59 years of both sexes who do not carry out the exercise program, inhabitants of Enguera and apparently active. The data analyzed was obtained from the placement of an Actigraph model GT3X BT accelerometer for a week and the collection of data from the various instruments such as the measurement of blood pressure and weight using the Tanita BC Scale. -545N, the Tinetti scale, the Time Up \& Go test, the Monopodal Test, the SPPB test, the Sit to Stand Test, the Borg scale, the IPAQ questionnaire and the FHSQ questionnaire.

02

Conditions studied

  • Old Age; Debility

Keywords

  • old adults
  • exercise
  • accelerometry
03

In context

Frailty

1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.

This study's planned enrollment of 140 is above the median of 81 across 767 interventional studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

University of Valencia is the lead sponsor of 357 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
59 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults over 59 years of age.
  • Patients who comply with accelerometer times for 7 days.
  • Patients who correctly complete the accelerometer registration sheet.
  • Patients who complete the

Exclusion criteria

Exclusion Criteria:

  • Patients who do not wear the accelerometer 600 minutes a day for at least 3 days on weekdays and 480 minutes for at least 1 day on the weekend.
  • Patients who suffer from illness during data collection.
  • Patients who do not wear the accelerometer for 7 days. Be in IPAQ category 1 (low level of AF).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Exercise T0

    Carrying out an exercise program one year in progress

    Other: Exercise program

  • Experimental
    Exercise T1

    Carrying out an exercise program without prior exercise

    Other: Exercise program

  • No intervention
    Control

    Control

Interventions

  • OtherExercise program

    Multimodal and multicompetent exercise program 2 days a week for 60 minutes and 1 day of walking exercise for 60 minutes.

06

What researchers measure

Primary outcomes

  1. MVPA

    Mooderate to vigorous amount of activity. Assess the amount of moderate to vigorous exercise during accelerometry for one week.

    Time frame: 1 year

Secondary outcomes

  1. Up & Go

    Evaluate basic mobility in older people and their probable gait and balance disorders. 1. Tell the elderly person to sit in the chair with their back supported by the backrest. 2\. Ask the person to get up from the chair, walk at a normal pace for a distance of 3 meters, have the person turns around, walks back to the chair and sits down again. 3. Measure the time the older person takes the test. Timing begins when the person He starts to get up from the chair and ends when he returns to the chair and sits down. 4\. Give a test try Normal: \<10 seconds. * Mild mobility disability: 11-13 seconds. * High risk of falls: \>13 seconds

    Time frame: 1 year

  2. Tinetti

    Test that analyzes certain variables to evaluate gait and balance. The higher the score, the better the performance. The highest score of the gait subscale is 12, for balance 16. The sum of both scores for fall risk. The higher the score\>the lower the risk \<19 High risk of falls

    Time frame: 1 year

  3. SPBB

    Short Physical Performance Battery is an instrument that evaluates three aspects of mobility: balance, walking speed and strength of movement. limbs or lower extremities to get up from a chair. Supports the probable detection of outcomes adverse events such as mortality and institutionalization, as well as their association with disability.

    Time frame: 1 YEAR

  4. Sit to Stand Test

    Assesses the functional strength of the lower limbs, A chair was required on a flat surface and the subject was asked not to lean on his arms to get up and sit down, therefore, he was given a test opportunity with the instruction not to lean on. The patient is informed that the test consists of performing as many repetitions as possible of getting up and sitting down in a chair during a period of 60 seconds and that the time elapsed to the tenth repetition of getting up and sitting down will be timed at the same time. .

    Time frame: 1 year

  5. IPAQ

    To estimate the level of mobility of older people. It includes seven questions that ask how often, for how long, and with what intensity the individual performed both moderate and vigorous activities during the past week, questions about time spent walking, and time spent sitting.

    Time frame: 1 year

  6. FHSQ

    Specific to foot health, measuring quality of life based on foot pain, functional competence, footwear, and overall foot health. The first section consists of 13 questions measuring. The second section consists of 20 questions with Likert-type responses in 4 items. In the last section, the individual's sociodemographic information is collected. Regarding the interpretation of the results, given that the questionnaire does not provide a total score, the individual's responses must be entered into a computer application that will quantify a score from 0 to 100, with 0 being the worst state of health and 100 being the best.

    Time frame: 1 year

  7. Bood pressure

    systolic and diastolic blood pressure measurement

    Time frame: 1 year

  8. Sex

    Sex

    Time frame: o week , basaline

  9. BMC

    Body mass index

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06842849
Responsible party
CARMEN GARCÍA GOMARIZ (Assistant Professor of Nursing, University of Valencia) — Principal investigator
First posted
Feb 24, 2025
Start date
Oct 22, 2025
Primary completion
Jul 30, 2026
Completion
Dec 31, 2026 (estimated)
Last update
Sep 11, 2026

Study contacts

CARMEN GARCÍA GOMARIZ, Phd
Contact
Carmen.garcia-gomariz@uv.es
637787861
CARMEN GARCÍA GOMARIZ
Contact
Carmen.garcia-gomariz@uv.es
637787861
CARMEN GARCÍA GOMARIZ
principal investigator · UNIVERSITAT DE VALÉNCIA DEPARTAMENTO D'INFERMERIA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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