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De trainingscapaciteit verbeteren met een op maat gemaakte fysieke activiteitsinterventie (PALS)

5 november 2026 bijgewerkt door: Wake Forest University Health Sciences

Verbetering van de inspanningscapaciteit met een op maat gemaakte fysieke activiteitsinterventie bij lymfoompatiënten die een behandeling ondergaan

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

105

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • North Carolina
      • Winston-Salem, North Carolina, Verenigde Staten, 27157
        • Wake Forest Baptist Comprehensive Cancer Center
    • Virginia
      • Richmond, Virginia, Verenigde Staten, 23298
        • Virginia Commonwealth University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: 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.

Diagnostische toets: Cardiopulmonary exercise testing

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

Diagnostische toets: MRI scan

Images of the heart will be taken.

Gedragsmatig: Quality of Life 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.

Gedragsmatig: 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.

Ander: Blood draws

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.
Experimenteel: 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.
Diagnostische toets: Cardiopulmonary exercise testing

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

Diagnostische toets: MRI scan

Images of the heart will be taken.

Gedragsmatig: Quality of Life 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.

Gedragsmatig: 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.

Ander: Blood draws

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Peak VO2
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Peak Exercise Cardiac Output
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Wake Forest University Health Sciences

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: William Hundley, MD, Wake Forest Baptist Comprehensive Cancer Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2023

Primaire voltooiing (Werkelijk)

12 oktober 2026

Studie voltooiing (Geschat)

31 maart 2027

Studieregistratiedata

Eerst ingediend

20 oktober 2022

Eerst ingediend dat voldeed aan de QC-criteria

25 oktober 2022

Eerst geplaatst (Werkelijk)

27 oktober 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

5 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB00087763
  • 4R33CA226960-03 (Subsidie/contract van de Amerikaanse NIH)
  • WFBCCC 98622 (Andere identificatie: Wake Forest Baptist Comprehensive Cancer Center)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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