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- Essai clinique NCT04708873
Effect of High Intensity Aerobic & Resistance Interval Training on Body Composition, Visceral Adiposity and Myocardial Function in Overweight and Obese Adults
12 janvier 2021 mis à jour par: Foundation University Islamabad
The obesity epidemic, predisposing to cardio-metabolic diseases, has increased two-folds over the last decade with a global alarming cost of obesity-associated illnesses, thus representing a grave peril for the survival of public health care systems.
It is need of the time to develop evidence-based, time-efficient and cost-effective strategies to prevent and manage obesity.
This study would compare the effects of 2 types of exercise regimes providing data on their beneficial effects on body composition and myocardial function along with reducing the central adiposity.
This study may also be used as a novel intervention strategy for primary prevention of cardiovascular and metabolic diseases by modification of a major risk factor i.e. obesity in Pakistani population, consequently reducing the burden of morbidity and mortality from cardiometabolic diseases.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
Obesity is one of the major public health issues of this century.
Over the last decade, the prevalence of obesity has increased globally, making it an emerging epidemic and threatening the survival of health care systems.
Obesity has long been recognized as the major factor predisposing to cardio-metabolic diseases.The positive role of structured exercise for reducing the mortality and morbidity rates of obese and sedentary adults is well established.
But exercise engagement is seen to be quite low in obese adults mainly due to lack of time and non-adherence to exercise training programs.
Current trends are now focusing towards another type of exercise regime known as high intensity interval training (HIIT), which is composed of repetitive short to long (< 45 sec to 4 min) bouts of high intensity exercise alternating with rest or recovery periods.
Resistance training can also stimulate changes in body composition indices as well as maintain the reduced fat mass after training.
Thus resistance exercises are recommended as an adjunct for obesity management by reduction in risk factors.
Hence, this study is designed to determine the effects of high intensity interval training in combination with resistance exercises verses moderate intensity continuous training on multiple outcome variables including body composition parameters, visceral adiposity, lipid profile and myocardial function in overweight and obese adult population of Pakistan.
Afte r obtaining written informed consent from paricipants, they will be screened using 2020 PAR-Q plus and randomly allocated to one of the 2 groups.
A self-structured demographic sheet would be employed for recording demographics and required data including the findings of lab investigations.
Then participants will be required to undergo all the physical assessment measures such as anthropometric data, 6 minute walk test, lipid profile, body composition analysis and echocardiography.
Physical activity levels and QOL would be assessed by filling IPAQ and SF 36 respectively.
Exercise training plans would be performed thrice a week on alternate days for a total duration of 10 weeks.
All measurements (anthropometric, cardiac, blood and body composition analyses) would be performed at baseline and later after the 10 weeks intervention period.
Exercise intensity will be determined by individualized target heart rate zones using Karvonen formula.
Strength training intensity will be determined based on 1-RM.
Necessary adjustments to speed/grade and resistance will be made over the course of the intervention to ensure that target heart rate zones are achieved at all times.
Apart from the exercise programs, a general similar dietary guidance by a nutritionist would also be provided to both of the groups to avoid unhealthy dietary habits.
Type d'étude
Interventionnel
Inscription (Anticipé)
52
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Federal
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Islamabad, Federal, Pakistan, 46000
- Recrutement
- Foundation University Institute of Rehabilitation Sciences.
-
Contact:
- Zara Khalid, PhD*
- Numéro de téléphone: +92 333 5415822
- E-mail: zara.khalid@fui.edu.pk
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 55 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Individuals categorized as Overweight (BMI 23.0 to 24.9) and Obese-Class I (BMI 25.0 to 29.9).
- Both males & females willing to participate in the study.
- Otherwise healthy young adults aged 18-35 and middle-aged adults (36-55 years).
- No participation in an exercise or PA program during the last 6 months prior to the study.
- Participants able to complete 6-minute walk test as sub-maximal evaluation test without provoking sign and symptoms.
Exclusion Criteria:
- Any diagnosed neuromuscular, cardiac, renal, lung, liver disease.
- Individuals with implantable electrical devices such as pacemakers.
- Any physical or psychological dysfunction that hinders participation in the study.
- Individuals already participating in any structured program for weight loss including dietary interventions or usage of nutritional supplements.
- Individuals unable to complete 6 minute walk test due to any reason (dyspnea, fatigue, chest pain etc).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: High Intensity Interval Training Group
Participants in this group will initially undergo continuous aerobic training to achieve a baseline fitness level, after which HIIT and resistance training will be employed.
Warm-up period will be followed by 4 bouts of 4-minute interval treadmill running and stationary bike cycling at 80-95% of the measured HR reserve, interspersed with active recovery phase at 55-70% HRR.
After this resistance exercises will be performed in a circuit fashion for strengthening the upper limbs, lower limbs and trunk.
The session will be ended with a 5-7 minute cool-down period
|
4x4 min intervals of high intensity treadmill running (80-95% of HRR, RPE 7-10 on Borg's category ratio scale of perceived exertion) interspersed with active recovery (slow jogging or fast walking at 50-70% HRR).
HIIT-Resistance exercises 2 sessions per week, RPE 5 (hard) 6-8 RM, 1-3 sets of as many repetitions as possible in 60 seconds, active recovery 20-60 seconds b/w exercises,
|
|
Comparateur actif: Moderate Intensity Continuous Training Group
Participants in this group will also initially undergo continuous aerobic training to achieve a baseline fitness level, after which the intensity will be increased to moderate continuous training achieving 55-70% of HRR.
Every session will be preceded by appropriate warm-up and end with cool down.
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Moderate intensity continuous Aerobic exercises (Stationary cycling for 15-20 min followed by treadmill walking for 15-20 min) at 55-70% 55-70% of HRR, RPE 3-4 on Borg's category ratio scale of perceived exertion.
The session will be preceded by 5-7 minute warm-up & 7-10 min cool-down.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage Body Fat
Délai: 10 weeks
|
Percentage body fat will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and expressed in forms of percentage (%).
|
10 weeks
|
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Visceral fat area
Délai: 10 weeks
|
Visceral fat area will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and expressed in form of centimeter square.
|
10 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Left Ventricular Mass
Délai: 10 weeks
|
Left Ventricular Mass depicting myocardial function will be assessed via Echocardiography
|
10 weeks
|
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Left Ventricular Ejection Fraction
Délai: 10 weeks
|
Left Ventricular Ejection Fraction depicting myocardial function will be assessed via Echocardiography
|
10 weeks
|
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Cholesterol/HDL ratio
Délai: 10 weeks
|
Will be analyzed using Lipid Profile blood testing.
A higher score represents poor outcome.
|
10 weeks
|
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Fat free mass
Délai: 10 weeks
|
Fat free mass will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and will be expressed in kg.
|
10 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
25 novembre 2020
Achèvement primaire (Anticipé)
30 décembre 2021
Achèvement de l'étude (Anticipé)
30 décembre 2021
Dates d'inscription aux études
Première soumission
1 janvier 2021
Première soumission répondant aux critères de contrôle qualité
12 janvier 2021
Première publication (Réel)
14 janvier 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 janvier 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 janvier 2021
Dernière vérification
1 janvier 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FUI/CTR/2020/13
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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