Back to resultsImpact of Respiratory Training in Lymphoma Survivors
Primary Purpose
Hodgkin Lymphoma, Non Hodgkin Lymphoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inspiratory muscle strength training
Sham Inspiratory muscle strength training
Sponsored by
About this trial
This is an interventional basic science trial for Hodgkin Lymphoma
Eligibility Criteria
Inclusion Criteria: Age 18 - 80 Primary cancer diagnosis of lymphoma Able and willing to participate in a supervised exercise program at the Anschutz Health and Wellness Center Provides a signed physician exercise clearance form SBP > 120 mmHg Completion of curative cancer treatment over 12 months prior (individuals on maintenance therapy will be included) Possession of a smartphone compatible with the IMST training application (available on both Android and Apple). Exclusion Criteria: oSecond active cancer diagnosis oPlanned active cancer treatment or change in current treatment in the next 6 months Severe obesity (BMI > 40 kg/m2) or underweight (BMI < 18.5 kg/m2) Unstable weight (> 3 kg change in body mass in last 3 months) Significant metabolic disorder (e.g. diabetes type II) Uncontrolled thyroid disease Recent changes in hypertensive medication (within last 3 months) Greater than 100 min of self-reported regular exercise per week Any medical condition that would impact the safety of, or participation in, an exercise program, including: Significant pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, or interstitial lung disease Known cardiovascular disease, significant hypertension (> 180/120), or a recent cardiac event (within past 6 months) Orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries Advanced rheumatoid arthritis or chronic widespread pain conditions such as fibromyalgia
Sites / Locations
- Anschutz Health and Wellness
- University of Colorado Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lymphoma Survivors IMST
Lymphoma Survivors sham IMST
Arm Description
Participants will undergo a version of the BfitBwell Cancer Exercise Program physical assessment, which assesses physical fitness and function.
Participants will undergo a version of the BfitBwell Cancer Exercise Program physical assessment, which assesses physical fitness and function.
Outcomes
Primary Outcome Measures
Total Participants Recruited
Count of number of participants recruited into the study
Enrolled Participants per Month
Average number of participants enrolled per month of the study
Valid Assessments per Participant
Adherence to 75% of the program will be deemed acceptable
Session Attendance per Participant
Adherence to 75% of the program will be deemed acceptable
Total Participants Completing the Intervention
Adherence to 75% of the program will be deemed acceptable
Systolic Blood Pressure
Resting systolic blood pressure, collected in triplicate
Secondary Outcome Measures
Molecular Markers - Acetylcholine-stimulated production of nitric oxide
Serum will be used to perform experiments in which purchased cultured endothelial cells will be exposed to 10% serum from human subjects for 24 hours. The investigators will measure acetylcholine-stimulated production of nitric oxide (NO) in endothelial cells following serum incubation. Serum will be collected via venipuncture performed at the CTRC and stored at -80°C until analysis.
Molecular Markers - Acetylcholine-stimulated basal reactive oxygen species production
Serum will be used to perform experiments in which purchased cultured endothelial cells will be exposed to 10% serum from human subjects for 24 hours. The investigators will measure acetylcholine-stimulated basal reactive oxygen species (ROS) production in endothelial cells following serum incubation. Serum will be collected via venipuncture performed at the CTRC and stored at -80°C until analysis.
Cardiorespiratory Fitness (CRF) will be assessed via estimated VO2max
This will be measured by the Tecumseh Step Test. Participants step on and off an 8" step for 3 min, at a metronome-controlled pace of 24 steps/min. Afterward, they immediately sit down, and heart rate is recorded at 30 s and 1 min after completion (using Polar F4 heart rate monitors). These recovery heart rates are then entered into a predictive formula, along with patient biometric information (age, weight, gender), to calculate an estimated VO2max.
Physical function primarily assessed by the 6MWT
Participants will be instructed to walk as far as possible in a six minute period on an indoor track.
Metabolomics analyses will be performed on blood samples
Metabolomics analyses will be performed on blood samples collected during a standardized aerobic exercise session. Samples will be collected before exercise, immediately after, and after 30 min of recovery. Samples will be collected with patient-centric Tasso+ devices (Tasso, Inc) which minimize the discomfort of collection.
Functional Assessment of Cancer Therapy - General (FACT-G, assessing quality of life)
A 27-item scale commonly used to assess overall quality of life in the general cancer survivor population. Scores range from 0-108 with higher scores indicate higher quality of life.
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue)
A 13-item scale commonly used to assess cancer-related fatigue in cancer survivors. Scores range from 0-52 with higher scores indicate lower levels of fatigue.
Godin Leisure Time Physical Activity Questionnaire
A 6-item scale asking participants the amount of time spent in light, moderate, and vigorous physical activity during the past week. Scores start at 0 with no upper range. Higher scores indicate more minutes of activity per week.
Hospital Anxiety and Depression Scale (HADS)
14 item scale indicating levels of anxiety and depression in clinical populations. Scores range from 0-21 for anxiety and depression scales. Higher scores indicate higher levels of anxiety and depression.
Cardiac risk factors will be collected from medical history forms
These risk factors will be included in secondary analyses to assess if participants at higher known risk of cardiac disease differ in their response to the intervention.
Full Information
NCT ID
NCT05938127
First Posted
June 30, 2023
Last Updated
July 28, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT05938127
Brief Title
Impact of Respiratory Training in Lymphoma Survivors
Official Title
The Impact of Inspiratory Muscle Strength Training and Personalized Exercise Prescription on Metabolism, Cardiovascular Function, and Cardiorespiratory Fitness in Lymphoma Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
High-resistance inspiratory muscle strength training (IMST) is a time-efficient (~5 minutes/day) form of exercise that employs an affordable, handheld device which impedes inspiratory breathing to train the diaphragm and accessory respiratory muscles and has demonstrated improvements in both cardiovascular health (9 mmHg reduction in systolic blood pressure, 45% improvement in vascular endothelial function) and improve exercise tolerance (12% increase in treadmill exercise time) in generally healthy midlife/older adults. Therefore, this approach may circumvent preventative hurdles to exercise, and augment the effects of exercise for capable survivors.
Detailed Description
Cancer survivorship has been steadily improving as a result of earlier detection and improved therapies. Behind cancer recurrence, the primary cause of morbidity and mortality among survivors stems from the onset of cardiovascular disease that arises in part due to cardiotoxic chemo and radiation therapies. The increased risk of cardiovascular disease is particularly high in specific survivor populations, such as lymphoma survivors. Although exercise has been demonstrated to improve both recovery after cancer therapy and quality of life, both physical and logistical hurdles may prohibit certain patients from accessing this intervention. High-resistance inspiratory muscle strength training (IMST) is a time-efficient (~5 minutes/day) form of exercise that employs an affordable, handheld device which impedes inspiratory breathing to train the diaphragm and accessory respiratory muscles and has demonstrated improvements in both cardiovascular health (9 mmHg reduction in systolic blood pressure, 45% improvement in vascular endothelial function) and improve exercise tolerance (12% increase in treadmill exercise time) in generally healthy midlife/older adults. Therefore, this approach may circumvent preventative hurdles to exercise, and augment the effects of exercise for capable survivors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Non Hodgkin Lymphoma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lymphoma Survivors IMST
Arm Type
Experimental
Arm Description
Participants will undergo a version of the BfitBwell Cancer Exercise Program physical assessment, which assesses physical fitness and function.
Arm Title
Lymphoma Survivors sham IMST
Arm Type
Experimental
Arm Description
Participants will undergo a version of the BfitBwell Cancer Exercise Program physical assessment, which assesses physical fitness and function.
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle strength training
Other Intervention Name(s)
IMST
Intervention Description
High-resistance inspiratory muscle strength training (IMST) is a time-efficient (~5 minutes/day) form of exercise that employs an affordable, handheld device which impedes inspiratory breathing to train the diaphragm and accessory respiratory muscles
Intervention Type
Device
Intervention Name(s)
Sham Inspiratory muscle strength training
Other Intervention Name(s)
Sham IMST
Intervention Description
Low-resistance inspiratory muscle strength training
Primary Outcome Measure Information:
Title
Total Participants Recruited
Description
Count of number of participants recruited into the study
Time Frame
2 years
Title
Enrolled Participants per Month
Description
Average number of participants enrolled per month of the study
Time Frame
2 years
Title
Valid Assessments per Participant
Description
Adherence to 75% of the program will be deemed acceptable
Time Frame
5 months
Title
Session Attendance per Participant
Description
Adherence to 75% of the program will be deemed acceptable
Time Frame
5 months
Title
Total Participants Completing the Intervention
Description
Adherence to 75% of the program will be deemed acceptable
Time Frame
2 years
Title
Systolic Blood Pressure
Description
Resting systolic blood pressure, collected in triplicate
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Molecular Markers - Acetylcholine-stimulated production of nitric oxide
Description
Serum will be used to perform experiments in which purchased cultured endothelial cells will be exposed to 10% serum from human subjects for 24 hours. The investigators will measure acetylcholine-stimulated production of nitric oxide (NO) in endothelial cells following serum incubation. Serum will be collected via venipuncture performed at the CTRC and stored at -80°C until analysis.
Time Frame
5 months
Title
Molecular Markers - Acetylcholine-stimulated basal reactive oxygen species production
Description
Serum will be used to perform experiments in which purchased cultured endothelial cells will be exposed to 10% serum from human subjects for 24 hours. The investigators will measure acetylcholine-stimulated basal reactive oxygen species (ROS) production in endothelial cells following serum incubation. Serum will be collected via venipuncture performed at the CTRC and stored at -80°C until analysis.
Time Frame
5 months
Title
Cardiorespiratory Fitness (CRF) will be assessed via estimated VO2max
Description
This will be measured by the Tecumseh Step Test. Participants step on and off an 8" step for 3 min, at a metronome-controlled pace of 24 steps/min. Afterward, they immediately sit down, and heart rate is recorded at 30 s and 1 min after completion (using Polar F4 heart rate monitors). These recovery heart rates are then entered into a predictive formula, along with patient biometric information (age, weight, gender), to calculate an estimated VO2max.
Time Frame
5 months
Title
Physical function primarily assessed by the 6MWT
Description
Participants will be instructed to walk as far as possible in a six minute period on an indoor track.
Time Frame
5 months
Title
Metabolomics analyses will be performed on blood samples
Description
Metabolomics analyses will be performed on blood samples collected during a standardized aerobic exercise session. Samples will be collected before exercise, immediately after, and after 30 min of recovery. Samples will be collected with patient-centric Tasso+ devices (Tasso, Inc) which minimize the discomfort of collection.
Time Frame
5 months
Title
Functional Assessment of Cancer Therapy - General (FACT-G, assessing quality of life)
Description
A 27-item scale commonly used to assess overall quality of life in the general cancer survivor population. Scores range from 0-108 with higher scores indicate higher quality of life.
Time Frame
5 months
Title
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue)
Description
A 13-item scale commonly used to assess cancer-related fatigue in cancer survivors. Scores range from 0-52 with higher scores indicate lower levels of fatigue.
Time Frame
5 months
Title
Godin Leisure Time Physical Activity Questionnaire
Description
A 6-item scale asking participants the amount of time spent in light, moderate, and vigorous physical activity during the past week. Scores start at 0 with no upper range. Higher scores indicate more minutes of activity per week.
Time Frame
5 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
14 item scale indicating levels of anxiety and depression in clinical populations. Scores range from 0-21 for anxiety and depression scales. Higher scores indicate higher levels of anxiety and depression.
Time Frame
5 months
Title
Cardiac risk factors will be collected from medical history forms
Description
These risk factors will be included in secondary analyses to assess if participants at higher known risk of cardiac disease differ in their response to the intervention.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 - 80
Primary cancer diagnosis of lymphoma
Able and willing to participate in a supervised exercise program at the Anschutz Health and Wellness Center
Provides a signed physician exercise clearance form
SBP > 120 mmHg
Completion of curative cancer treatment over 12 months prior (individuals on maintenance therapy will be included)
Possession of a smartphone compatible with the IMST training application (available on both Android and Apple).
Exclusion Criteria:
oSecond active cancer diagnosis
oPlanned active cancer treatment or change in current treatment in the next 6 months
Severe obesity (BMI > 40 kg/m2) or underweight (BMI < 18.5 kg/m2)
Unstable weight (> 3 kg change in body mass in last 3 months)
Significant metabolic disorder (e.g. diabetes type II)
Uncontrolled thyroid disease
Recent changes in hypertensive medication (within last 3 months)
Greater than 100 min of self-reported regular exercise per week
Any medical condition that would impact the safety of, or participation in, an exercise program, including:
Significant pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, or interstitial lung disease
Known cardiovascular disease, significant hypertension (> 180/120), or a recent cardiac event (within past 6 months)
Orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries
Advanced rheumatoid arthritis or chronic widespread pain conditions such as fibromyalgia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jared Scorsone
Phone
7207249601
Email
jared.scorsone@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Marker, PT, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anschutz Health and Wellness
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jared Scorsone
Phone
720-724-9601
Email
jared.scorsone@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Ryan J Marker, PT, PhD
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jared Scorsone
Phone
720-724-9601
Email
jared.scorsone@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Ryan Marker, PT, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Respiratory Training in Lymphoma Survivors
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