Physical Activity Clinical Trial
Official title:
Effect of a Multicomponent Intervention on Physical Fitness and Metabolic Risk Markers in Children and Adolescents: A Pilot Study
Verified date | September 2016 |
Source | Federal University of Paraíba |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
The aim of this study was: to evaluate the effectiveness of a multicomponent pilot intervention in improving physical fitness (PF) and metabolic risk markers in children and adolescents; and examine if possible changes in PF are associated with metabolic risk markers in children and adolescents exposed to intervention. For such, a multicomponent pilot intervention was performed, consisting of sessions of physical exercise and nutrition education.The study included 35 children and adolescents (ages 7-13) divided into two groups: a intervention group (INT, n = 17) and a control one (CONT, n = 18). The sample underwent two moments of data collection (T0 and T1). The 1-hour exercise sessions were held based on an intensity above 65% of maximum HR. To assess the metabolic risk markers, analyzes of total cholesterol, HDL-C fraction, LDL-c fraction, triglycerides, blood glucose, insulin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were conducted in T0 and T1. Physical activity (PA) was assessed by accelerometry (Actigraph, GT3-X model, Florida) for 10 consecutive days. The health related PF components were evaluated throw different tests 20m Shuttle-run Test; handgrip dynamometry (TKK 5101 tightening D; Tokyo Japan); standing feet jump Test; Abdominal Test; trunk extension test; and body mass index (BMI) was calculated. Motor fitness was assessed by coordinations Test für Kinder - KTK. To assess food consumption, a 24-hour recall was held. For statistical analysis, the t-Student test and General Linear Model (GLM) - ANCOVA for repeated measures test with post-hoc Bonferroni (p <0.05) were performed. Multilinear regressions were done to analyse associations between measured outcomes.
Status | Completed |
Enrollment | 35 |
Est. completion date | November 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 7 Years to 13 Years |
Eligibility |
Inclusion Criteria: - volunteered to participate in the study - Excess weight / obesity for experimental group - Aged 7 to 13 years Exclusion Criteria: - No complete evaluation protocol |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Clarice Maria de Lucena Martins |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cardiorespiratory fitness | Shuttle-run Test 20m - participants ran between two lines 20m away, keeping the rhythm corresponding to the audio signals from a prerecorded CD. The initial speed was 8.5km / h and increased 0.5km / h every minute (one minute corresponds to one stage). Participants were instructed to run in a straight line, at their own pace, and returning at the end of each beep. The test was completed when the participant failed to reach the final lines simultaneously with the audio signals on two consecutive occasions, or when it ended the test due to fatigue. The procedure was done previously described by Leger et al (1988). | 3-months | Yes |
Primary | Muscle strength of the upper limbs | Pinch manual - using a manual dynamometer with adjustable pinch (TKK 5101 Grip D; Takey, Tokyo Japan). The participant held a gradual and continuous hold for at least two seconds, with the right and left hand, with the elbow in full extension as standard procedure described above (CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC). NATIONAL CENTER FOR HEALTH STATISTICS ( NCHS), 2011). The test was conducted twice on each hand and recorded the maximum score achieved in kilograms. For analysis it computed the average value between the measurements of each hand. | 3-months | Yes |
Primary | muscle strength of the lower limbs: | jump test with feet together - from an initial position with your feet parallel, immediately behind a line drawn on the ground, the participant leaped forward as much as possible, on a hard, non-slip surface. The test was performed twice and the best score was recorded in centimeters. | 3-months | Yes |
Primary | Abdominal endurance: | Test repetitions of abdominal - was to make the largest possible number of sit-ups, up to a maximum of 75 for one minute. Lying on a mattress with your knees bent, arms straight, palms face down and his head resting on the mattress. a banner was placed with a width of 11.5 cm, under the performer's knees. This track was used to determine the route to be traveled by sliding your hands on the mattress. | 3-months | Yes |
Primary | Flexibility of the trunk: | trunk extension test - consisted of starting from the prone position, with legs and outstretched arms and hands under the thighs, raise trunk controllably up to a maximum of 30 cm (measured between your chin and the mattress). There were two attempts and validated the best of them. | 3-months | Yes |
Primary | Flexibility of the lower limbs: | Test sit and reach - was to achieve the greatest distance possible with your hands, one over the other, with the participant barefoot, with the left leg bent and the other with the foot flat on the measuring bench. There were two attempts for each leg and used the average value between the two attempts for each leg. | 3-months | Yes |
Primary | Body composition: | body mass index (BMI) - was calculated using the formula (weight / height) 2. | 3-months | Yes |
Secondary | Cholesterol Markers | Blood samples from the participants were collected after a nocturnal 12 hour-fasting, by laboratory specialists, through peripheral puncture in the cubital vein. The analysis of CT, HDL-C was carried out by spectrophotometry (Cobas Integra 400 Plus) with Roche® kits. The LDL-C fraction was indirectly calculated using the Friedewald formula (1972). | 3-months | Yes |
Secondary | Hepatic markers | Blood samples from the participants were collected after a nocturnal 12 hour-fasting, by laboratory specialists, through peripheral puncture in the cubital vein.The aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels were determined by enzyme kinetic assay for spectrophotometrically obtained after centrifugation 10 minutes / 3500 rpm. | 3-months | Yes |
Secondary | Insulin | Blood samples from the participants were collected after a nocturnal 12 hour-fasting, by laboratory specialists, through peripheral puncture in the cubital vein. Insulin was determined by Luminex-100 IS (Integrated System: Luminex Corporation, Austin, TX, USA), using the Linco Human Gut Hormone panel kit (Linco Research Inc., MO, USA). The insulin resistance was determined by HOMA-IR | 3-months | Yes |
Secondary | Triglycerides | Blood samples from the participants were collected after a nocturnal 12 hour-fasting, by laboratory specialists, through peripheral puncture in the cubital vein. The analysis of TGL, was carried out by spectrophotometry (Cobas Integra 400 Plus) with Roche® kits. | 3-months | Yes |
Secondary | Glucose | Blood samples from the participants were collected after a nocturnal 12 hour-fasting, by laboratory specialists, through peripheral puncture in the cubital vein. The analysis of glucose was carried out by spectrophotometry (Cobas Integra 400 Plus) with Roche® kits. | 3-months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Active, not recruiting |
NCT03903874 -
Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt
|
N/A | |
Recruiting |
NCT03662438 -
HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)
|
N/A | |
Withdrawn |
NCT04540523 -
Home-Based Exergaming Intervention
|
N/A | |
Recruiting |
NCT03250000 -
Changes in Microcirculation and Functional Status During Exacerbation of COPD
|
N/A | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
Completed |
NCT05019482 -
Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time
|
N/A | |
Completed |
NCT03253406 -
Health Wearables and College Student Health
|
N/A | |
Not yet recruiting |
NCT05985460 -
A Very Brief Intervention to Increase the Intention to Practice Physical Activity
|
N/A | |
Completed |
NCT03700736 -
The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups
|
N/A | |
Completed |
NCT03380143 -
Whole-of-Community Youth Population Physical Activity
|
N/A | |
Completed |
NCT03170921 -
Psychophysiological Characterization of Different Capoeira Performances in Experienced Individuals
|
N/A | |
Completed |
NCT04973813 -
Active Choice Intervention About Physical Activity for Physically Inactive Adults
|
N/A | |
Completed |
NCT03982095 -
Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
|
||
Completed |
NCT03271112 -
Frailty Prevention in Elders From Reunion Island
|
N/A | |
Completed |
NCT05670223 -
Healthy Activities Improve Lives
|
N/A | |
Completed |
NCT04894929 -
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement
|
N/A | |
Recruiting |
NCT04578067 -
Empowering Immigrant Women for Active and Healthy Lifestyle
|
N/A | |
Completed |
NCT03297567 -
Physical Therapy Guidelines For Hospitalized Elderly
|
N/A |