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Improving Exercise Capacity With a Tailored Physical Activity Intervention (PALS)

Primary Purpose

Non Hodgkin Lymphoma, Heart; Functional Disturbance, Hodgkin Lymphoma

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise with Trainerize application

Cardiopulmonary exercise testing

MRI scan

Quality of Life Questionnaires

Cognitive and Brain Function Questionnaires

Blood draws

About this trial

This is an interventional supportive care trial for Non Hodgkin Lymphoma focused on measuring Exercise capability, Brain activity

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
Expected to receive an anthracycline based chemotherapeutic regimen or other potentially cardiotoxic cancer therapies (e.g. chemotherapy regimens [anthracyclines, trastuzumab]), 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)
Claustrophobia
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

Sites / Locations

Wake Forest Baptist Comprehensive Cancer CenterRecruiting
Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Physical Activity Intervention

Healthy Living Intervention (Control Arm)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Peak Exercise Cardiac Output

Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.

Change in Calculated A-V Oxygen Levels

Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.

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.

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.

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.

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.

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.

Change in 6-Minute Walk Distance

Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.

Health-Related Quality of Life Questionnaire (FACT-Lym)

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

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.

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.

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.

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.

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

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).

Full Information

NCT ID

NCT05595577

First Posted

October 20, 2022

Last Updated

July 24, 2023

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05595577

Brief Title

Improving Exercise Capacity With a Tailored Physical Activity Intervention

Acronym

PALS

Official Title

Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma Patients Undergoing Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2023 (Actual)

Primary Completion Date

September 1, 2025 (Anticipated)

Study Completion Date

September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Hodgkin Lymphoma, Heart; Functional Disturbance, Hodgkin Lymphoma, Quality of Life

Keywords

Exercise capability, Brain activity

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

All images will be processed offline by an image analyst blinded to study group

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Physical Activity Intervention

Arm Type

Experimental

Arm Description

Arm Title

Healthy Living Intervention (Control Arm)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Exercise with Trainerize application

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Cardiopulmonary exercise testing

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

MRI scan

Intervention Description

Images of the heart will be taken.

Intervention Type

Behavioral

Intervention Name(s)

Quality of Life Questionnaires

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive and Brain Function Questionnaires

Intervention Description

Intervention Type

Other

Intervention Name(s)

Blood draws

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Peak VO2

Description

An analysis of covariance (ANCOVA) model will be used to assess post-intervention group differences in VO2, adjusted for baseline peak VO2.

Time Frame

At baseline and 6 months after study intervention

Secondary Outcome Measure Information:

Title

Change in Peak Exercise Cardiac Output

Description

Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.

Time Frame

At baseline and 6 months after study intervention

Title

Change in Calculated A-V Oxygen Levels

Description

Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.

Time Frame

At baseline and 6 months after study intervention

Title

Changes in Measurements of Pre-exercise Left Ventricular Function

Description

Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.

Time Frame

At baseline and 6 months after study intervention

Title

Change in Neurocognitive Function - Hopkins Verbal Learning Test

Description

Time Frame

At baseline and 6 months after study intervention

Title

Change in Neurocognitive Function - Controlled Oral Word Association Test (COWAT)

Description

Time Frame

At baseline and 6 months after study intervention

Title

Change in Neurocognitive Function - Digit Span-Backward Test

Description

Time Frame

At baseline and 6 months after study intervention

Title

Change in Neurocognitive Function - Trail Making Test

Description

Time Frame

At baseline and 6 months after study intervention

Title

Change in 6-Minute Walk Distance

Description

Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.

Time Frame

At baseline, 3 months and 6 months after study intervention

Title

Health-Related Quality of Life Questionnaire (FACT-Lym)

Description

Time Frame

At baseline, 3 months and 6 months after study intervention

Title

Fatigue Questionnaire

Description

Time Frame

At baseline, 3 months and 6 months after study intervention

Title

Change in Physical Activity Levels - Godin Leisure Time Exercise Questionnaire

Description

Time Frame

At baseline, 3 months and 6 months after study intervention

Title

Change in Physical Function - Balance Test

Description

Time Frame

At baseline, 3 months and 6 months after study intervention

Title

Change in Physical Function - Chair Stand Test

Description

Time Frame

At baseline, 3 months and 6 months after study intervention

Title

Change in Physical Function - 4-Meter Walk Gait Speed Test

Description

Time Frame

At baseline, 3 months and 6 months after study intervention

Title

Change in Physical Function - Grip Strength

Description

Time Frame

At baseline, 3 months and 6 months after study intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Expected to receive an anthracycline based chemotherapeutic regimen or other potentially cardiotoxic cancer therapies (e.g. chemotherapy regimens [anthracyclines, trastuzumab]), 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) Claustrophobia 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Study Coordinator

Phone

336-758-3728

scnorton@wakehealth.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Hundley, MD

Organizational Affiliation

Wake Forest Baptist Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest Baptist Comprehensive Cancer Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

W G Hundley, MD

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

W. G. Hundley, MD

12. IPD Sharing Statement

Plan to Share IPD

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Improving Exercise Capacity With a Tailored Physical Activity Intervention

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