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)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Joel Puente Fernández, PhD Student
- Número de teléfono: +34626610821
- Correo electrónico: jp2979a@gre.ac.uk
Copia de seguridad de contactos de estudio
- Nombre: Fernando J Naclerio, Dr
- Número de teléfono: +44 (0)20 8331 8441
- Correo electrónico: F.J.Naclerio@greenwich.ac.uk
Ubicaciones de estudio
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Avery Hill, London.
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London, Avery Hill, London., Reino Unido, SE9 2BT
- University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
Otros nombres:
The information about it has been detailed in advance.
Otros nombres:
This intervention has also been described in advance.
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Comparador activo: 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.
Otros nombres:
This intervention has also been described in advance.
Otros nombres:
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Comparador falso: 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.
Otros nombres:
This intervention has also been described in advance.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Fat Mass
Periodo de tiempo: Through study completion, an average of 1 year.
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Assessment of the total adipose tissue via Bioelectrical Impedance.
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Through study completion, an average of 1 year.
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Fat-free Mass
Periodo de tiempo: Through study completion, an average of 1 year.
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Assessment of the total lean mass via Bioelectrical Impedance.
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Through study completion, an average of 1 year.
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Health Perception questionnaire
Periodo de tiempo: 6 weeks.
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Short Form of 12 questions. Higher scores mean better outcomes (score from 0 to 100). |
6 weeks.
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Pittsburgh Sleep Quality Index
Periodo de tiempo: 6 weeks.
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Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5). |
6 weeks.
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Stress Level and Mental Health
Periodo de tiempo: 6 weeks.
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Short Form of 4 questions. Higher scores mean worse outcomes (score from 1 to 5). |
6 weeks.
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Adherence to a Mediterranean Diet (PREDIMED questionnaire)
Periodo de tiempo: 6 weeks.
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Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5). |
6 weeks.
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International Physical Activity Questionnaire
Periodo de tiempo: 6 weeks.
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7 questions. Higher scores mean better outcomes (score from 1 to 5). |
6 weeks.
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Single-Leg balance
Periodo de tiempo: 6 Weeks
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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
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Upper-Body push strength
Periodo de tiempo: 6 Weeks
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Number of push-ups in 15 seconds. The score will be the number of Push-Ups performed (higher scores mean better outcomes). |
6 Weeks
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Lower-body mechanical power
Periodo de tiempo: 6 Weeks
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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
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Recovery
Periodo de tiempo: 6 Weeks
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Adherence to the treatment (regular training, supplement intake and healthy eating)
Periodo de tiempo: 6 weeks
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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.
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6 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Fernando J Naclerio, Dr, University of Greenwich
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UGreenwich2
Información sobre medicamentos y dispositivos, documentos del estudio
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