- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07662551
Effectiveness of a Physical Activity Program (EPAP)
Effectiveness of a Physical Activity Program in Adults and the Elderly
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Pará
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Castanhal, Pará, Brazil, 68746-630
- Universidade Federal do Pará
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults
- Older adults
- Over 50 years of age of both sexes
- Participating in an extension program at Federal University of Pará
- Self-reported diagnosis of hypertension.
Exclusion Criteria:
- Participants who did not agree with the study
- Participants Who have low attendance in classes (below 50%).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group (IG)
The IG followed this protocol: Week 1 - Day 1: thirty minutes of aerobic resistance exercises and 30 minutes of balance exercises; Day 2: 30 minutes of balance exercises. Week 2 - Day 1: thirty minutes of strength exercises for upper and lower limbs and 30 minutes of balance exercises; Day 2: 30 minutes of balance exercises. After week 2, the training returned to week 1 until completing ten weeks. The balance exercises used in the classes were static and dynamic, with 6 to 7 exercises and a duration of 30 to 45 minutes. In the first three weeks, the balance exercises were performed with two sets of 12 to 15 repetitions. From the fourth week onwards, there was a progression to three sets of 12 repetitions, and in the last four weeks, the exercises were performed with four sets of 12 repetitions. |
Participants who were randomized to the intervention group performed 10 weeks of body balance exercise.
Participants who were randomized to the intervention or control group performed 10 weeks of multicomponent exercise.
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Active Comparator: Control
Week 1 - Days 1 and 2: 30 minutes of aerobic endurance exercises and 30 minutes of flexibility exercises. Week 2: Days 1 and 2: 30 minutes of strength training for upper and lower limbs and 30 minutes of balance exercises. After week 2, the training returned to week 1 until completing the ten weeks. |
Participants who were randomized to the intervention or control group performed 10 weeks of multicomponent exercise.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in lower limb muscle strength
Time Frame: Baseline and after 10 weeks
|
The assessments included tests of lower limb strength (sit-to-stand test) - In this test, the participant must sit down and stand up from a chair.
The total number of repetitions in 30 seconds is recorded.
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Baseline and after 10 weeks
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Change in upper limb strength
Time Frame: Baseline and 10 weeks
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Upper limb strength (forearm flexion test) - The forearm flexion test assesses upper body strength using two-kilogram dumbbells for women and four-kilogram dumbbells for men, a chair with a backrest (without armrests), and a stopwatch.
The participant must be seated against the chair with an upright posture, performing the greatest number of bicep curls with their dominant hand in thirty seconds.
|
Baseline and 10 weeks
|
|
Change in lower limb flexibility
Time Frame: Baseline and 10 weeks
|
Lower limb flexibility (sit-and-reach test) - With the leg extended (but not overextended), the participant slowly leans forward, keeping the spine as straight as possible and the head aligned with the spine.
The participant attempts to touch their toes by sliding their hands, one on top of the other, with the tips of their middle fingers, down the extended leg.
The evaluator uses a 45 cm ruler and records the distance (cm) to the toes (minimum result) or the distance (cm) that can be reached beyond the toes (maximum result).
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Baseline and 10 weeks
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Change in body balance
Time Frame: Baseline and 10 weeks
|
agility/dynamic balance (sit-to-walk 2.44m and return to sit test) - The person being evaluated starts in a seated position in a chair with an upright posture, hands on thighs and feet on the floor with one foot slightly in front of the other.
At the signal, the person being evaluated gets up from the chair (they can push off with their thighs or the chair), walks as quickly as possible around the cone, returns to the chair and sits down.
For reliable timing, the evaluator should start the stopwatch at the signal movement, whether or not the person has started moving, and stop the stopwatch the exact moment the person sits down in the chair.
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Baseline and 10 weeks
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Change in upper limb flexibility
Time Frame: Baseline and 10 weeks
|
Upper limb flexibility (behind-the-back reach test) - Standing, the subject places their preferred hand on the same shoulder, palm open and fingers extended, reaching as far as possible to the middle of their back (elbow pointing upwards).
The hand of the other arm is placed behind the back, palm upwards, reaching upwards as far as possible in an attempt to touch or overlap the extended middle fingers of both hands.
Without moving the subject's hands, the evaluator helps to verify if the middle fingers of each hand are pointing towards each other.
The overlap distance, or the distance between the tips of the middle fingers, is measured to the nearest centimeter.
Negative results (-) represent the shortest distance between the middle fingers; positive results (+) represent the overlap of the middle fingers.
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Baseline and 10 weeks
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Change in aerobic endurance
Time Frame: Baseline and 10 weeks
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Aerobic endurance (6-minute walk) - At the indicated signal, participants walk as fast as possible (without running) around the course as many times as they can within the time limit.
During the test, participants may stop and rest if necessary, and then resume walking.
The evaluator must move onto the course after all participants have started and must record the elapsed time.
The 6-minute walk test uses a 45.7 m course measured in 4.57 m segments.
The distance covered in the 6-minute interval will be assessed.
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Baseline and 10 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in body mass
Time Frame: Baseline and 10 weeks
|
Body mass (BM) - measurement obtained in kilograms using a digital scale.
|
Baseline and 10 weeks
|
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Height Assessment
Time Frame: Baseline and 10 weeks
|
Height (meters) - will be obtained using a stadiometer.
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Baseline and 10 weeks
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Change in waist circumference
Time Frame: Baseline and 10 weeks
|
waist circumference (WC) - measurement obtained in centimeters using a measuring tape
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Baseline and 10 weeks
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Change in hip circumference
Time Frame: Baseline and 10 weeks
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Hip circumference (HC) - a measurement obtained in centimeters using a measuring tape.
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Baseline and 10 weeks
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Change in Body Mass Index (BMI)
Time Frame: Baseline and 10 weeks
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Body Mass Index (BMI) - will be assessed by dividing body mass in kilograms by height squared in meters.
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Baseline and 10 weeks
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Change in Percentage of fat
Time Frame: Baseline and 10 weeks
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Percentage of fat (%BF) - a measurement obtained as a percentage using a bioimpedance scale.
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Baseline and 10 weeks
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Change in percentage of skeletal muscle
Time Frame: Baseline and 10 weeks
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Percentage of skeletal muscle (%SM) - a measurement obtained as a percentage using a bioimpedance scale.
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Baseline and 10 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPAP
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
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