- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06842849
Impact of a Physical Exercise Program in a Rural Area
Impact of a Physical Exercise Program on the Physical, Podiatric and Mental Health of the Adult Population in a Rural Area
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: CARMEN GARCÍA GOMARIZ, PhD
- Phone Number: 637787861
- Email: Carmen.garcia-gomariz@uv.es
Study Contact Backup
- Name: CARMEN GARCÍA GOMARIZ
- Phone Number: 637787861
- Email: Carmen.garcia-gomariz@uv.es
Study Locations
-
-
-
Valencia, Spain, 46010
- Recruiting
- Universitat de València
-
Contact:
- CARMEN GARCÍA GOMARIZ, PhD
- Phone Number: 637787861
- Email: Carmen.garcia-gomariz@uv.es
-
Contact:
- CARMEN GARCÍA GOMARIZ
- Phone Number: 637787861
- Email: Carmen.garcia-gomariz@uv.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 informed consent
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Exercise T0
Carrying out an exercise program one year in progress
|
Multimodal and multicompetent exercise program 2 days a week for 60 minutes and 1 day of walking exercise for 60 minutes.
|
|
Experimental: Exercise T1
Carrying out an exercise program without prior exercise
|
Multimodal and multicompetent exercise program 2 days a week for 60 minutes and 1 day of walking exercise for 60 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MVPA
Time Frame: 1 year
|
Mooderate to vigorous amount of activity.
Assess the amount of moderate to vigorous exercise during accelerometry for one week.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Up & Go
Time Frame: 1 year
|
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.
|
1 year
|
|
Tinetti
Time Frame: 1 year
|
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
|
1 year
|
|
SPBB
Time Frame: 1 YEAR
|
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. |
1 YEAR
|
|
Sit to Stand Test
Time Frame: 1 year
|
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. .
|
1 year
|
|
IPAQ
Time Frame: 1 year
|
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.
|
1 year
|
|
FHSQ
Time Frame: 1 year
|
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.
|
1 year
|
|
Bood pressure
Time Frame: 1 year
|
systolic and diastolic blood pressure measurement
|
1 year
|
|
Sex
Time Frame: o week , basaline
|
Sex
|
o week , basaline
|
|
BMC
Time Frame: 1 year
|
Body mass index
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: CARMEN GARCÍA GOMARIZ, UNIVERSITAT DE VALÉNCIA DEPARTAMENTO D'INFERMERIA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Behavior
- Frailty
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Resistance Training
Other Study ID Numbers
- ESS_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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