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テーラーメイドの身体活動介入による運動能力の向上 (PALS)

2026年11月5日 更新者:Wake Forest University Health Sciences

治療中のリンパ腫患者におけるテーラーメイドの身体活動介入による運動能力の改善

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

105

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • North Carolina
      • Winston-Salem、North Carolina、アメリカ、27157
        • Wake Forest Baptist Comprehensive Cancer Center
    • Virginia
      • Richmond、Virginia、アメリカ、23298
        • Virginia Commonwealth University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~85年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

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

Exclusion Criteria:

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:独身

武器と介入

参加者グループ / アーム
介入・治療
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.

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.

Maximal peak VO2 (to monitor the body's oxygen consumption) and 6-minute exercise walking test.

Images of the heart will be taken.

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.

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.

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.

Maximal peak VO2 (to monitor the body's oxygen consumption) and 6-minute exercise walking test.

Images of the heart will be taken.

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.

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.

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.

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
Change in Peak VO2
時間枠:At baseline and 6 months after study intervention

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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Peak Exercise Cardiac Output
時間枠:At baseline and 6 months after study intervention

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
時間枠:At baseline and 6 months after study intervention

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
時間枠:At baseline and 6 months after study intervention

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
時間枠:At baseline and 6 months after study intervention

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)
時間枠:At baseline and 6 months after study intervention

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
時間枠:At baseline and 6 months after study intervention

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
時間枠:At baseline and 6 months after study intervention

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
時間枠:At baseline, 3 months and 6 months after study intervention

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)
時間枠:At baseline, 3 months and 6 months after study intervention

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
時間枠:At baseline, 3 months and 6 months after study intervention

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
時間枠:At baseline, 3 months and 6 months after study intervention

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
時間枠:At baseline, 3 months and 6 months after study intervention

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
時間枠:At baseline, 3 months and 6 months after study intervention

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
時間枠:At baseline, 3 months and 6 months after study intervention

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
時間枠:At baseline, 3 months and 6 months after study intervention

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:William Hundley, MD、Wake Forest Baptist Comprehensive Cancer Center

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年3月1日

一次修了 (実際)

2026年10月12日

研究の完了 (推定)

2027年3月31日

試験登録日

最初に提出

2022年10月20日

QC基準を満たした最初の提出物

2022年10月25日

最初の投稿 (実際)

2022年10月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月12日

QC基準を満たした最後の更新が送信されました

2026年11月5日

最終確認日

2026年11月1日

詳しくは

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

米国FDA規制機器製品の研究

はい

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