Long-term Intervention Effects of a Personalized, Home-based Exercise Program and Nutritional Advice, Along With the Inclusion of a Pre-workout Multi-ingredient Supplement on the Body Composition, Functional Capacity and Quality of Life of Middle-aged and Older Adults (40-70 Years)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The methodology will follow a Home-based, online, double-blinded, randomised, long-term design. The participants recruited will be active, middle-aged and older healthy adults. The supplement intake will be a Pre-workout supplement intake or a placebo intake. The exercise training will be a Progressive Resistance Training, with sessions of ~1 hour (3 times/week). The intervention will last for a minimum of one year and the possibility to prolong it to another one (two years of intervention) if the adherence to the treatment was higher to the 75% of the participants (of, at least, 85% of the training sessions and supplementation intake).
The outcomes that will be assessed are: Body composition (fat mass and fat-free mass), physical performance (short test designed by Go Fit Lab: single-leg standing balance, upper-body strength - maximum number of push-ups repetitions in 15 seconds -, lower-body mechanical power - vertical jump -, agility/velocity - 30 seconds of static running at maximum velocity -, recovery assessment - 60 seconds monitoring of heart rate after the previous test -), Happiness Score (designed by Go Fit, including different self-reported validated tests, such as: Par-Q+, ACSM Cardiovascular Risk Factors Questionnaire, SF-12 for quality of life and self-perceived health status, PSS-4 Stress and mental health, Pittsburgh Sleeping Quality test, PREDIMED test: adherence to Mediterranean diet eating patterns, and the IPAQ short form), and for every workout: Self-perceived energy feeling (Questionnaire: Energy Level, Fatigue, Alertness and Focus for the Task), Rate of Perceived Exertion (OMNI RES Scale and Borg Scale) and adherence to regular physical exercise practise, healthy nutritional patterns, and supplement intake.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Joel Puente Fernández, PhD Student
- Numéro de téléphone: +34626610821
- E-mail: jp2979a@gre.ac.uk
Sauvegarde des contacts de l'étude
- Nom: Fernando J Naclerio, Dr
- Numéro de téléphone: +44 (0)20 8331 8441
- E-mail: F.J.Naclerio@greenwich.ac.uk
Lieux d'étude
-
-
Avery Hill, London.
-
London, Avery Hill, London., Royaume-Uni, SE9 2BT
- University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Healthy adults (no current injuries or illnesses which may interfere with the project).
- Recreationally active adults (a minimum of 3 and a maximum of 5 days of training sessions per week: combining resistance and endurance).
Exclusion Criteria:
- Participants younger than 40 or older than 70 years old.
- Participants with hard injuries, disabilities or pathologies.
- People taking medication or other supplements which may interfere with the multi-ingredient pre-workout or the training sessions.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Multi-Ingredient Pre-workout Supplement
This group of participants will intake a multi-ingredient supplement around ~15 minutes before every workout. The nutritional information of the supplement is: ~90 Kcal. for 25g of powder: carbohydrates -isomaltulose, fructose, maltodextrin- 15 g, essential amino-acids -Beta-alanine: 2.5g, L-arginine AKG: 2.5g, L-Leucine: 800mg, Taurine: 500mg, L-citrulline: 500mg- 6.8 g, Creatine monohydrate: 2.0g, Guarana Extract: 800mg, total caffeine: 160mg, and Magnesium: 112.5mg. They will also follow a previously designed progressive resistance training (3 times a week, around 1 hour a day, consisting of different exercises). Also, they will receive a specific guideline with simple tips to improve their nutritional patterns. The training sessions and the nutritional guideline will be the same for the three groups. |
Every important issue has been detailed before.
Autres noms:
The information about it has been detailed in advance.
Autres noms:
This intervention has also been described in advance.
Autres noms:
|
|
Comparateur actif: Isocaloric Placebo
This group of participants will intake an isocaloric (only carbohydrates: Maltodextrin) supplement comparator, around ~15 minutes before every workout. The nutritional information of the supplement is: ~90 Kcal. for 23g of powder. They will also follow a previously designed progressive resistance training (3 times a week, around 1 hour a day, consisting of different exercises). Also, they will receive a specific guideline with simple tips to improve their nutritional patterns. The training sessions and the nutritional guideline will be the same for the three groups. |
The information about it has been detailed in advance.
Autres noms:
This intervention has also been described in advance.
Autres noms:
|
|
Comparateur factice: Control
These participants will drink a non-caloric admixture with the same taste, texture and flavour. They will also follow a previously designed progressive resistance training (3 times a week, around 1 hour a day, consisting of different exercises). Also, they will receive a specific guideline with simple tips to improve their nutritional patterns. The training sessions and the nutritional guideline will be the same for the three groups. |
The information about it has been detailed in advance.
Autres noms:
This intervention has also been described in advance.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fat Mass
Délai: Through study completion, an average of 1 year.
|
Assessment of the total adipose tissue via Bioelectrical Impedance.
|
Through study completion, an average of 1 year.
|
|
Fat-free Mass
Délai: Through study completion, an average of 1 year.
|
Assessment of the total lean mass via Bioelectrical Impedance.
|
Through study completion, an average of 1 year.
|
|
Health Perception questionnaire
Délai: 6 weeks.
|
Short Form of 12 questions. Higher scores mean better outcomes (score from 0 to 100). |
6 weeks.
|
|
Pittsburgh Sleep Quality Index
Délai: 6 weeks.
|
Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5). |
6 weeks.
|
|
Stress Level and Mental Health
Délai: 6 weeks.
|
Short Form of 4 questions. Higher scores mean worse outcomes (score from 1 to 5). |
6 weeks.
|
|
Adherence to a Mediterranean Diet (PREDIMED questionnaire)
Délai: 6 weeks.
|
Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5). |
6 weeks.
|
|
International Physical Activity Questionnaire
Délai: 6 weeks.
|
7 questions. Higher scores mean better outcomes (score from 1 to 5). |
6 weeks.
|
|
Single-Leg balance
Délai: 6 Weeks
|
Standing in one leg only, be capable of holding the position for 15 seconds. Performed with the dominant leg at first and the non-dominant leg afterwards. Score from 1 to 15 (higher scores mean better outcomes). |
6 Weeks
|
|
Upper-Body push strength
Délai: 6 Weeks
|
Number of push-ups in 15 seconds. The score will be the number of Push-Ups performed (higher scores mean better outcomes). |
6 Weeks
|
|
Lower-body mechanical power
Délai: 6 Weeks
|
Jump height with countermovement. The jump will be performed from a standing position, lateral to the wall and jumping to touch the wall as high as possible (with chalk in their finger-prints to mark the height they touched the wall). The score will be the height of the jump (higher scores mean better outcomes). |
6 Weeks
|
|
Recovery
Délai: 6 Weeks
|
Static running in 1m2 square as fast as possible for 30 seconds and immediately after, Heart Rate will be monitored for 1 minute The score will be the difference from the Maximum Heart Rate minus the Heart Rate after 1 minute recovery (higher scores mean better outcomes). |
6 Weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adherence to the treatment (regular training, supplement intake and healthy eating)
Délai: 6 weeks
|
The compliance with the training and supplementation protocols will be measured constantly, as well as the healthy eating patterns.
Those participants who have spent 7 days or more in a row without training or taking the supplement, as well as a final accomplishment of the 85% will be discarded from the final analysis.
|
6 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Fernando J Naclerio, Dr, University of Greenwich
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UGreenwich2
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .