- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04630977
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)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Joel Puente Fernández, PhD Student
- Numero di telefono: +34626610821
- Email: jp2979a@gre.ac.uk
Backup dei contatti dello studio
- Nome: Fernando J Naclerio, Dr
- Numero di telefono: +44 (0)20 8331 8441
- Email: F.J.Naclerio@greenwich.ac.uk
Luoghi di studio
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Avery Hill, London.
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London, Avery Hill, London., Regno Unito, SE9 2BT
- University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
The information about it has been detailed in advance.
Altri nomi:
This intervention has also been described in advance.
Altri nomi:
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Comparatore attivo: 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.
Altri nomi:
This intervention has also been described in advance.
Altri nomi:
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Comparatore fittizio: 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.
Altri nomi:
This intervention has also been described in advance.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Fat Mass
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Adherence to the treatment (regular training, supplement intake and healthy eating)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: Fernando J Naclerio, Dr, University of Greenwich
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
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Altri numeri di identificazione dello studio
- UGreenwich2
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