Home Based Exercise Program for Elderly Cancer Patients
Single Institution Randomized Controlled Study of a Home Based Exercise Program to Reduce Functional Decline, Cancer Related Fatigue (CRF and Improve Quality of Life for the Elderly Gynecologic Oncology Patient)
Implementation of a home based exercise program to reduce functional decline, cancer related fatigue (CRF) and improve quality of life in the elderly gynecologic oncology patient
Problem:
Can prevention of CRF and loss of function improve QOL in the elderly gynecologic oncology patient undergoing chemotherapy?
Support:
Fatigue and its impact on QOL is a major concern with the elderly patient receiving chemotherapy. When compared to younger adults QOL is more important than gain in survival for elderly patients. (Eyigor, et al., 2010).
The National Comprehensive Cancer Network recommends exercise as the most effective intervention for cancer related fatigue.
Methods:
This is a single institution randomized controlled study to evaluate a home based exercise program in elderly gynecologic oncology patients undergoing chemotherapy. Subjects will be randomized to the intervention group or to the control group receiving usual care.
Intervention group will receive a home exercise program 3 days weekly consisting of 30mins of strength and aerobic activity, utilizing a follow along exercise DVD and patient log to assist with compliance.
The two groups will be compared by 1) objective PT assessment with the Berg Balance and 6 minute walk test (before or after) Cycle 1 and 6, 2) subjective nursing assessment with the NHANES (National Health and Nutrition Examination Survey) and FACIT- F (Functional Assessment of Chronic Illness Therapy: Fatigue) prior to Cycle 1 (baseline),4 (midpoint), and following cycle 6 (completion).
Conclusion:
PT directed home exercise program may improve CRF, functional decline, and QOL in elderly gynecologic oncology patients undergoing chemotherapy.
調査の概要
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
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North Carolina
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Raleigh、North Carolina、アメリカ、27609
- Duke Raleigh Cancer Center
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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:
- Endometrial, Ovarian, Cervix, Vaginal Cancer Initiating Chemotherapy
- Age greater than or equal to 65yrs
- ECOG (Eastern Cooperative Oncology Group) performance status less than 3
- No current physical therapy intervention
- English speaking
Exclusion Criteria:
- Non-gynecologic malignancy
- Recurrent cancer
- Receiving radiation alone
- Gait or balance disturbance
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：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Intervention
Subjects randomized to intervention will receive Physical Therapist instructed exercise teaching.
They will receive a home exercise DVD and flip ring of exercises.
Subjects will be asked to perform home exercise 3 days weekly consisting of 13 strengthening/stretching exercises and 20 mins of aerobic exercise, walking or seated aerobics using ergometer.
Subjects will record their exercise on a log and return on day 1 of every cycle.
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Subjects randomized to intervention will receive Physical Therapist instructed exercise teaching.
They will receive a home exercise DVD and flip ring of exercises.
Subjects will be asked to perform home exercise 3 days weekly consisting of 13 strengthening/stretching exercises and 20 mins of aerobic exercise, walking or seated aerobics using ergometer.
Subjects will record their exercise on a log and return on day 1 of every cycle.
|
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介入なし：Observation
Subjects randomized to observation will only have physical therapy assessment using the Berg Balance Test and 6min Walk Test at baseline and end point.
These subjects will not receive any exercise teaching.
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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 |
|---|---|---|
|
Reduction in Cancer Related Fatigue (CRF)
時間枠：Baseline, +/- 7days of 4th chemo cycle (mid point), +/- 7 days of 3 weeks after 6th cycle (end point)
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CRF will be evaluated using the FACIT-F tool.
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Baseline, +/- 7days of 4th chemo cycle (mid point), +/- 7 days of 3 weeks after 6th cycle (end point)
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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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Quality of Life Improvement (QOL)
時間枠：Baseline, +/- 7days of cycle 4 of treatment (mid point), +/- 7 days of 3rd week after cycle 6 (end point)
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QOL will be evaluated using the NHANES and FACIT-F tools.
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Baseline, +/- 7days of cycle 4 of treatment (mid point), +/- 7 days of 3rd week after cycle 6 (end point)
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Reduction in Physical Functional Decline
時間枠：Baseline and +/- 7days of 3 weeks post 6th cycle (end point)
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Physical function will be evaluated using the Berg Balance Test and 6 Min Walk Test
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Baseline and +/- 7days of 3 weeks post 6th cycle (end point)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Alicia S. Johnson, ADN-RN、Duke University
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
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