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)
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Fat-free Mass
研究概览
简要总结
The purpose of this study is to analyse the potential benefits of ingesting a commercially available pre-workout multi-ingredient supplement providing ~90 Kcal. for 25g of powder: carbohydrates -isomaltulose, fructose, maltodextrin- 15 g, essential amino-acids -Beta-alanine -L-arginine AKG, L-Leucine, Taurine, L-citrulline- 6.8 g, Creatine monohydrate: 2g, Guarana Extract: 800mg, total caffeine: 160mg, and Magnesium: 112.5mg) vs Placebo CHO intake on body composition, physical performance, Happiness Score (specially designed by our sponsor company, including different self-reported and validated tests on their short form) and every workout: Self-perceived energy feeling and adherence to the intervention.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Every participant will be randomized to any of the groups. The principal investigator will be blinded for the supplement and allocation of the participants until the end of the analysis of the results after the intervention. Therefore, an external and third researcher will send the supplements to every participant and will keep the record of the randomised allocation of each of them until the end of the analysis of the last outcomes assessments collection.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Fat-free Mass
时间窗: Through study completion, an average of 1 year.
Assessment of the total lean mass via Bioelectrical Impedance.
Upper-Body push strength
时间窗: 6 Weeks
Number of push-ups in 15 seconds. The score will be the number of Push-Ups performed (higher scores mean better outcomes).
Health Perception questionnaire
时间窗: 6 weeks.
Short Form of 12 questions. Higher scores mean better outcomes (score from 0 to 100).
Pittsburgh Sleep Quality Index
时间窗: 6 weeks.
Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5).
Lower-body mechanical power
时间窗: 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).
Fat Mass
时间窗: Through study completion, an average of 1 year.
Assessment of the total adipose tissue via Bioelectrical Impedance.
Stress Level and Mental Health
时间窗: 6 weeks.
Short Form of 4 questions. Higher scores mean worse outcomes (score from 1 to 5).
Adherence to a Mediterranean Diet (PREDIMED questionnaire)
时间窗: 6 weeks.
Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5).
International Physical Activity Questionnaire
时间窗: 6 weeks.
7 questions. Higher scores mean better outcomes (score from 1 to 5).
Recovery
时间窗: 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).
Single-Leg balance
时间窗: 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).
次要结局
- Adherence to the treatment (regular training, supplement intake and healthy eating)(6 weeks)
研究者
Joel Puente
Principal Investigator
University of Greenwich