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)
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Joel Puente Fernández, PhD Student
- 電話番号：+34626610821
- メール：jp2979a@gre.ac.uk
研究連絡先のバックアップ
- 名前：Fernando J Naclerio, Dr
- 電話番号：+44 (0)20 8331 8441
- メール：F.J.Naclerio@greenwich.ac.uk
研究場所
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Avery Hill, London.
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London、Avery Hill, London.、イギリス、SE9 2BT
- University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
The information about it has been detailed in advance.
他の名前：
This intervention has also been described in advance.
他の名前：
|
|
アクティブコンパレータ：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.
他の名前：
This intervention has also been described in advance.
他の名前：
|
|
偽コンパレータ：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.
他の名前：
This intervention has also been described in advance.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Fat Mass
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adherence to the treatment (regular training, supplement intake and healthy eating)
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Fernando J Naclerio, Dr、University of Greenwich
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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