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治験 NCT05595577 (PALS)（対象：非ホジキンリンパ腫、心臓の機能障害、ホジキンリンパ腫、生活の質、ステージI乳癌、ステージII乳がん、ステージIII乳癌）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ウェイクフォレスト大学Improving Exercise Capacity With a Tailored Physical Activity Intervention (PALS)
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05595577 (PALS) は 介入研究 臨床試験 で、非ホジキンリンパ腫、心臓の機能障害、ホジキンリンパ腫、生活の質、ステージI乳癌、ステージII乳がん、ステージIII乳癌 に関するものです。現在は 募集中 で、2023年3月1日 から開始しています。100 名の参加者 の募集が計画されています。この治験は ウェイクフォレスト大学 によって主催され、2026年8月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月11日 です。
概要
The purpose of this research is to test whether participating in either a physical activity intervention or a series of educational classes will help to preserve exercise capability, heart function, brain-based activities (like memory), and quality of life.
Participants will be randomized to 1 of 2 pathways:
- First pathway consists of organized health workshops. These workshops are intended to provide information on topics such as proper nutrition, management of stress, sleep practices, and emphasis on a healthy lifestyle that may help the participants through cancer treatment. This pathway will also test whether stretching may help participants through cancer treatment.
- Second pathway participants will take part in some unsupervised and some potentially supervised moderate activity sessions each week throughout participants' cancer treatment to take place either remotely or in person, depending on availability of facilities at the time visits are scheduled.
詳細説明
Primary Objective: To determine if a >10% difference exists in the % change (i.e., 2.06 ml/kg/min difference) in peak VO2 (volume or amount of oxygen your body consume) from baseline to 6 months of intervention between participants receiving the Physical Activity Intervention (PAI) versus Healthy Living Intervention (HLI).
Secondary Objectives:
- To determine if a >10% difference exists in the % change in peak exercise cardiac output, calculated A-VO2 difference, and pre-exercise measures of left ventricular function from baseline to 6 months of intervention between participants receiving the PAI versus HLI.
- Among these same participants, 1) to compare PAI and HLI groups on their baseline to 3 & 6 months after initiating cancer treatment changes in 6-minWD, Health-Related Quality of Life (HRQOL), fatigue, strength, physical activity, cognitive & physical function, 2) to determine the relationships between the 6-month time-dependent changes in these and peak VO2; and 3) to examine whether time-dependent changes in peak exercise cardiac output and/or calculated arteriovenous oxygen difference are associated with similar time-dependent changes in peak VO2.
- Assess physical activity engagement via accelerometry.
公式タイトル
Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment
疾患／病気
非ホジキンリンパ腫心臓の機能障害ホジキンリンパ腫生活の質ステージI乳癌ステージII乳がんステージIII乳癌その他の研究識別子
- PALS
- IRB00087763
- 4R33CA226960-03 (米国NIHの助成金/契約)
- WFBCCC 98622 (その他の識別子) (Wake Forest Baptist Comprehensive Cancer Center)
NCT番号
開始日
2023-03-01
最終更新日
2025-09-11
終了予定日
2026-08-31
目標参加者数
100
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
Exercise capability
Brain activity
Brain activity
主目的
支持療法
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Physical Activity Intervention Participants will have the ability to attend one to two training sessions per week and 1-2 sessions per week at home (the 4th level of our multi-level intervention) or the location site using the Trainerize application to deliver the exercise prescription. | Exercise with Trainerize Application 1-2 sessions per week consisting of slow 15 minute aerobic warm, 20 minutes of strength training, 15 minutes progressive intensity aerobic exercise and 10 minute cool down (stretching/toning) with elastic bands. 心肺運動負荷試験 Maximal peak VO2 (to monitor the body's oxygen consumption) and 6-minute exercise walking test. MRIスキャン Images of the heart will be taken. 生活の質アンケート Participants will be asked to complete several questionnaires that will measure fatigue, general health, social determinants of health, cognitive function (tasks that assess memory, ability to count, etc.) and physical activity. The questionnaires will take 15-40 minutes to complete. Cognitive and Brain Function Questionnaires Participants will be asked to complete several questionnaires that will measure fatigue, general health, social determinants of health, cognitive function (tasks that assess memory, ability to count, etc.) and physical activity. The questionnaires will take 15-40 minutes to complete. 採血 Approximately 2 teaspoons of blood withdrawn from either a vein in your arm or a currently placed central line port-a-cath. A portion of blood from each visit will be used to collect information about blood cell count. |
実験的Healthy Living Intervention (Control Arm) Participants randomized to the control arm will participate in organized health workshops. Each session will last 60 minutes and will be offered on location and virtually (e.g., Zoom) over 6 months. Participants will meet once a week for the first 4 weeks, biweekly for 3 months, and once a month for the last 2 months for a total of 12 sessions. | 心肺運動負荷試験 Maximal peak VO2 (to monitor the body's oxygen consumption) and 6-minute exercise walking test. MRIスキャン Images of the heart will be taken. 生活の質アンケート Participants will be asked to complete several questionnaires that will measure fatigue, general health, social determinants of health, cognitive function (tasks that assess memory, ability to count, etc.) and physical activity. The questionnaires will take 15-40 minutes to complete. Cognitive and Brain Function Questionnaires Participants will be asked to complete several questionnaires that will measure fatigue, general health, social determinants of health, cognitive function (tasks that assess memory, ability to count, etc.) and physical activity. The questionnaires will take 15-40 minutes to complete. 採血 Approximately 2 teaspoons of blood withdrawn from either a vein in your arm or a currently placed central line port-a-cath. A portion of blood from each visit will be used to collect information about blood cell count. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in Peak VO2 | An analysis of covariance (ANCOVA) model will be used to assess post-intervention group differences in VO2, adjusted for baseline peak VO2. | At baseline and 6 months after study intervention |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in Peak Exercise Cardiac Output | Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach. | At baseline and 6 months after study intervention |
Change in Calculated A-V Oxygen Levels | Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach. | At baseline and 6 months after study intervention |
Changes in Measurements of Pre-exercise Left Ventricular Function | Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach. | At baseline and 6 months after study intervention |
Change in Neurocognitive Function - Hopkins Verbal Learning Test | The Hopkins Verbal Learning Test (HVLT-R) consists of memorization of a list of words to test the ability to recall immediately after memorization (immediate recall) and after a 20-minute delay (delayed recall). This test has three parts and two alternate forms. Total scores could range from 0 to 30. Lower raw scores indicate difficulties with the task. | At baseline and 6 months after study intervention |
Change in Neurocognitive Function - Controlled Oral Word Association Test (COWAT) | The Controlled Oral Word Association Test is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). COWAT is measured by calculating the total number of acceptable words produced for at the given letter of the alphabet. Errors and perseverations (word repetitions) are not included in this score. | At baseline and 6 months after study intervention |
Change in Neurocognitive Function - Digit Span-Backward Test | The digit span backward test is used to assess working memory. Participants are given a series of digits and asked to repeat them backward. The item score is the sum of the scores on the two trials for that item (range=0-2). The total raw score for backwards digit span is the sum of the item scores; maximum backwards digit span total raw score is 16 points. | At baseline and 6 months after study intervention |
Change in Neurocognitive Function - Trail Making Test | The Trail Making Test (TMT) asks patients to connect consecutive "targets" (numbers and/or letters) on a page arranged in a specific geometric pattern. Scoring is based on time taken to complete the test (e.g. 35 seconds yielding a score of 35) with lower scores being better. | At baseline and 6 months after study intervention |
Change in 6-Minute Walk Distance | Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach. | At baseline, 3 months and 6 months after study intervention |
Health-Related Quality of Life Questionnaire (FACT-Lym or FACT-B) | FACT-Lym is 42-item questionnaire to assess the quality of life for lymphoma patients. 5-point Likert scale - 0 (not at all) to 4 (very much). Subscale domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Lymphoma Subscale. Some items are reverse scored. Subscales scores are added to get the total score. The higher the score, the better the quality of life. Scores can range from 0-168.
FACT-B is a 37-item Functional Assessment of Cancer Therapy-Breast (FACT-B) that measures five domains of health-related quality of life in breast cancer patients. These include physical, social, emotional and functional well being on a Likert scale 0-4 with (not at all) to 4 (very much). The higher the score, the better quality of life. Scores can range from 0-148. | At baseline, 3 months and 6 months after study intervention |
Fatigue Questionnaire | Questionnaire to assess the difference in the level of fatigue participants experience will performing study interventions. 5-point Likert scale - 0 (not at all) to 4 (very much). The higher the score the higher level of fatigue participants experience. Score range 0-52. | At baseline, 3 months and 6 months after study intervention |
Change in Physical Activity Levels - Godin Leisure Time Exercise Questionnaire | The questionnaire is a 4-item measure used to classify participants' activity levels during a typical 7-day period based on how many times on average participants exercise more than 15 minutes during their free time of strenuous, moderate or mild exercise. | At baseline, 3 months and 6 months after study intervention |
Change in Physical Function - Balance Test | Participants will be asked to maintain balance for up to 30 seconds in three positions characterized by a progressive narrowing of the base support: heel of one foot beside the big toe of the other foot (semi-tandem position), heel of one foot in front of and touching the toes of the other foot (tandem position), and single leg stand. | At baseline, 3 months and 6 months after study intervention |
Change in Physical Function - Chair Stand Test | The repeated chair stand test will be performed using a straight-backed chair placed with its back against a wall. Participants will be first asked to stand from a sitting position without using their arms. If they can perform the task, they will then be asked to stand up and sit down five times as quickly as possible. The time to complete the task will be recorded. | At baseline, 3 months and 6 months after study intervention |
Change in Physical Function - 4-Meter Walk Gait Speed Test | The gait speed test will assess the participant's ability to walk 4 meters. Participants will be instructed to start at a marked walking course with toes touching the start line and when cued to start, will begin walking at their usual speed. The time to walk from the starting line to the end of the 4-meter walk will be recorded | At baseline, 3 months and 6 months after study intervention |
Change in Physical Function - Grip Strength | Grip strength will be assessed using an isometric handgrip dynamometer while the participant is seated with the head facing straight ahead. The elbow should be bent at a 90 degree angle and the wrist should be at the mid-prone position. The participant should exert maximally and quickly (about 1 second) and two trials should be made alternately with each hand, with at least 30 seconds between trials for the same hand (recorded in kilograms). | At baseline, 3 months and 6 months after study intervention |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
To be considered eligible, participants must meet all of the following criteria:
- Individuals aged 18- 85 years
- Diagnosed with stage I-IV Hodgkin's or non-Hodgkin's lymphoma or stage I-III breast cancer
- Expected to receive an anthracycline based chemotherapeutic regimen or other potentially cardiotoxic cancer therapies (e.g. chemotherapy regimens [anthracyclines, trastuzumab, rituximab]), immuno-therapies (immune checkpoint inhibitors [ICI's]) or radiation (within 8 weeks of completion of radiation).29-31
- Ability to speak and understand English
- Capacity to walk at least 2 city blocks (~.2 miles) on a flat surface
- Expected survival beyond 6 months.
- Must have an assistant that will help perform the home-based testing activities
If the patient meets any of these criteria they are excluded from the study:
- Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
- Recent history of alcohol or drug abuse, inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion (unless approved by the participant's physician and the Principal Investigator) NOTE: In the setting of active inflammation, participation will not be approved. If chronic disease is present and stable as judged by the participant's physician and the PI, participation will be approved.
- Contraindications to MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices (unless approved by the participant's physician and the Principal Investigator)
- Pregnant
- Unstable angina
- Contraindication for exercise training or testing
- Inability to exercise on a treadmill or stationary cycle
- Significant ventricular arrhythmias (>20 PVCs/min due to gating difficulty)
- Atrial fibrillation with uncontrolled ventricular response
- Acute myocardial infarction within 28 days
- Inability to provide informed consent
ウェイクフォレスト大学325 件のアクティブな治験を探索アメリカ国立がん研究所3030 件のアクティブな治験を探索試験中央連絡先
連絡先: Study Coordinator, 336-758-3027, [email protected]
連絡先: Pamela J. Grizzard, 804-628-6234, [email protected]
2 1カ国の場所
North Carolina
Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, 27157, United States
W G Hundley, MD, 研究責任者
募集中
Virginia
Virginia Commonwealth University, Richmond, Virginia, 23298, United States
W. G. Hundley, MD, 研究責任者
募集中