運動トレーニングと腎移植 (EXTRA)
腎移植患者における運動トレーニングの生理学的および分子的効果
The goal of this clinical trial is to investigate the physiological and molecular effects of exercise training in transplant recipients. The main questions it aims to answer are:
- Can exercise training improve physical fitness and muscle strength in transplant recipients?
- Can exercise training modulate inflammatory profile, hormones, lipid profile, and exercise-induced molecules in transplant recipients?
- Can exercise training improve blood pressure and endothelial health in transplant patients?
Participants will be invited to an exercise training program 6-month after their transplant surgery. Body composition, physical assessment, and blood draw will be assessed at baseline and 24-weeks after exercise or control regimen.
Researchers will compare exercise group vs. routine care group to see if exercise training impact the health-related outcomes of this population.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
The study will involve inviting participants to join an exercise training program six months after their transplant surgery. The research will include baseline assessments and measurements, such as body composition, physical assessment, and blood draws. These assessments will be conducted both at the beginning of the study and 24 weeks after participants have undergone either the exercise regimen or a control regimen.
The research team will compare two groups: the exercise group and the routine care group. The goal is to examine whether participating in an exercise training program has a significant impact on various health-related outcomes in transplant recipients when compared to individuals receiving standard care.
This clinical trial seeks to understand the potential benefits of exercise training on physical fitness, quality of life, inflammatory and molecular profiles, as well as cardiovascular health in individuals who have undergone organ transplantation. The comparison between the exercise group and the routine care group will provide valuable insights into the effectiveness of exercise interventions for this specific population.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
参加基準
適格基準
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:
- Medical Authorization:
- Stable Health Status
- Medication Consistency
- No History of Severe Cardiovascular Events
- No Major Orthopedic Issues
- Non-Smokers or Consistent Smoking Habits
- Ability to Comply with Study Protocols
Exclusion Criteria:
- Inability to Comply
- Cognitive disorders
- Unwillingness to Continue
- Unstable Health Conditions
- Physical limitations during the protocol
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：ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：Exercise training group
The training programs will encompass three phases, with a gradual progression in both intensity and duration. Each phase will span a duration of four weeks, culminating in a comprehensive 24-week training regimen. |
Participants will engage in combined training five times a week, with activities including 2 minutes of stationary marching and a set of 15 repetitions for squats, bilateral hip abduction, plantar flexion, floor abdominal exercises, and arm flexion with the knee close to the ground. Additionally, twice a week on non-consecutive days, volunteers partake in 20 minutes of aerobic walking. The second program starts with a 2-minute stationary march, followed by 2 sets of 12 repetitions for free squats, hip abduction, plantar flexion, stiff-legged deadlifts, arm flexion with knee support, floor abdominal exercises, and concludes with 30 minutes of aerobic exercise. The third program starts with a 2-minute stationary march, followed by 3 sets of 12 repetitions for free squats, hip abduction, plantar flexion, stiff-legged deadlifts, arm flexion, floor abdominal exercises, and includes thrice-weekly aerobic sessions lasting 30 minutes each.
他の名前：
|
|
介入なし：Control group
Control group will continue their usual care without exercise interventions. |
|
|
アクティブコンパレータ：Continue exercise
Following the 24-week training regimen, patients will have the option to decide whether they wish to continue their exercise training. This group will include individuals who choose to persist with their exercise routine. |
Following the 24-week training regimen, patients will have the option to decide whether they wish to continue their exercise training. This group will include individuals who choose to persist with their exercise routine. |
|
アクティブコンパレータ：Discontinue exercise
Following the 24-week training regimen, patients will have the option to decide whether they wish to continue their exercise training. This group will comprise individuals who opted not to continue their exercise routine. |
Following the 24-week training regimen, patients will have the option to decide whether they wish to continue their exercise training. This group will comprise individuals who opted not to continue their exercise routine. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physical fitness - VO2peak
時間枠：Baseline, after 24-weeks and at the end of the protocol
|
Cardiopulmonary test |
Baseline, after 24-weeks and at the end of the protocol
|
|
Isometric muscle strength
時間枠：Baseline, after 24-weeks and at the end of the protocol
|
Handgrip strength |
Baseline, after 24-weeks and at the end of the protocol
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Inflammatory profile
時間枠：Baseline, after 24-weeks and at the end of the protocol
|
Interleukin 6, interleukin 10, and tumor necrosis factor |
Baseline, after 24-weeks and at the end of the protocol
|
|
Urea-to-creatinine ratio
時間枠：Baseline, after 24-weeks and at the end of the protocol
|
Urea and creatinine will be combined to report urea-to-creatinine ratio |
Baseline, after 24-weeks and at the end of the protocol
|
|
Blood glucose
時間枠：Baseline, after 24-weeks and at the end of the protocol
|
Fasting blood glucose levels |
Baseline, after 24-weeks and at the end of the protocol
|
|
Graft rejection
時間枠：Through study completion, an average of 2 years
|
Number of patients that rejected their graft |
Through study completion, an average of 2 years
|
協力者と研究者
協力者
協力者
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 79266224.1.0000.0029
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Data obtained through this study may be provided to qualified researchers with academic interest in exercise and transplantation. Data or samples shared will be coded. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
IPD 共有時間枠
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
IPD 共有アクセス基準
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
IPD 共有サポート情報タイプ
- SAP
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。