Exercise in Improving Mobility and Reducing Fatigue and/or Weakness in Older Cancer Survivors
A RENEW Intervention for Elderly Cancer Survivors
RATIONALE: Exercise may help improve mobility and relieve fatigue and/or weakness in cancer survivors. It is not yet known whether exercise is more effective than standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors.
PURPOSE: This randomized clinical trial is studying exercise to see how well it works compared to standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors.
調査の概要
状態
詳細な説明
OBJECTIVES:
- Compare the perception of, and the patterns of change in fatigue, weakness, physical activity level, and functional status in elderly cancer survivors who undergo Resistance Exercise via Negative-Eccentric Work (RENEW) vs standard care.
- Compare changes in muscle structure, function (strength + power production and metabolic function) and mobility.
- Evaluate the patient's adherence to and satisfaction with the RENEW intervention.
OUTLINE: This is a prospective, randomized, controlled, longitudinal study. Patients are randomized to 1 of 2 intervention arms.
- Arm I: Patients undergo resistance exercise via negative-eccentric work (RENEW), using a special seated stationary leg exercise machine, 3 times a week for up to 12 weeks. Exercise exertion and duration is gradually increased weekly for the first 4-5 weeks of RENEW.
- Arm II: Patients receive standard care. In both arms, fatigue, weakness, physical activity, functional status, muscle structure and function, and mobility are assessed at baseline and then at 12 weeks after completion of study intervention. Fatigue and weakness are also assessed weekly during study intervention. Patients in arm I also undergo isometric strength assessment weekly during RENEW and assessment of adherence to and satisfaction with RENEW at 12 weeks after completion of RENEW.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Utah
-
Salt Lake City、Utah、アメリカ、84112
- Huntsman Cancer Institute at University of Utah
-
-
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
DISEASE CHARACTERISTICS:
- Survivor of breast, prostate, colon, lung, lymphoma, ovarian, bladder, or esophageal cancer with no evidence of disease
- At least moderate levels of fatigue and/or weakness
Impaired mobility but ambulatory and medically able to participate in an exercise regimen
- No impaired knee flexion, defined as < 90º
PATIENT CHARACTERISTICS:
- Folstein Mini-Mental Status Examination score ≥ 23
- No extreme claustrophobia
- No diagnosed chronic fatigue syndrome/disorder
No neurological impairments, including the following:
- Central nervous system disorder (e.g., multiple sclerosis or Parkinson's disease)
- Neurological insult (cerebrovascular attack) that manifests in a mobility disorder
- No myopathic disease (e.g., focal myopathy) that effects skeletal muscle structure/function
- No rheumatological disease that has an effect on muscle and/or mobility (e.g., polymyalgia rheumatica)
PRIOR CONCURRENT THERAPY:
More than 6 months since prior regular aerobic or resistance exercise
- Regular exercise defined as 2-3 times per week
- At least 6 months since prior cancer treatment (surgery, radiation, and/or chemotherapy )
- No concurrent cancer-related treatment other than hormonal therapy
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:支持療法
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:独身
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 |
---|---|---|
Patient perception and pattern of change
時間枠:3 months of training followed by 6 and 12 months of no formal training
|
To explore the participant's perception and pattern of change in fatigue, weakness, physical activity level and functional status
|
3 months of training followed by 6 and 12 months of no formal training
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Structural and function changes
時間枠:3 months of training followed by 6 and 12 months of no formal training
|
To explore whether changes in muscle structure and function (strength and power production and metabolic function) and mobility occur following twelve weeks of training with RENEW
|
3 months of training followed by 6 and 12 months of no formal training
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Paul C. LaStayo, PhD, PT、University of Utah
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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
- 14551
- P30CA042014 (米国 NIH グラント/契約)
- R21CA114523 (米国 NIH グラント/契約)
- UUMC-R21CA114523
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
米国で製造され、米国から輸出された製品。
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。
exercise interventionの臨床試験
-
University of Erlangen-Nürnberg Medical SchoolKlinikum Nürnberg完了
-
Shanghai Jiao Tong University School of Medicine積極的、募集していない
-
University of MichiganNational Institute on Drug Abuse (NIDA)募集
-
University of TorontoUniversity Health Network, Toronto; University of Western Ontario, Canada; Institute for Clinical... と他の協力者完了
-
University of PittsburghCenters for Disease Control and Preventionまだ募集していません暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
-
University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了