Impact of Respiratory Training in Lymphoma Survivors
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lymphoma Survivors IMST Participants will undergo a version of the BfitBwell Cancer Exercise Program physical assessment, which assesses physical fitness and function. |
Device: Inspiratory muscle strength training
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
Other Names:
|
| Experimental: Lymphoma Survivors sham IMST Participants will undergo a version of the BfitBwell Cancer Exercise Program physical assessment, which assesses physical fitness and function. |
Device: Sham Inspiratory muscle strength training
Low-resistance inspiratory muscle strength training
Other Names:
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Outcome Measures
Primary Outcome Measures
- Total Participants Recruited [2 years]
Count of number of participants recruited into the study
- Enrolled Participants per Month [2 years]
Average number of participants enrolled per month of the study
- Valid Assessments per Participant [5 months]
Adherence to 75% of the program will be deemed acceptable
- Session Attendance per Participant [5 months]
Adherence to 75% of the program will be deemed acceptable
- Total Participants Completing the Intervention [2 years]
Adherence to 75% of the program will be deemed acceptable
- Systolic Blood Pressure [5 months]
Resting systolic blood pressure, collected in triplicate
Secondary Outcome Measures
- Molecular Markers [5 months]
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. We will measure acetylcholine-stimulated production of nitric oxide (NO) and 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 [5 months]
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 [5 months]
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 [5 months]
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) [5 months]
A 27-item scale commonly used to assess overall quality of life in the general cancer survivor population. Higher scores indicate higher quality of life.
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) [5 months]
A 13-item scale commonly used to assess cancer-related fatigue in cancer survivors. Higher scores indicate lower levels of fatigue.
- Godin Leisure Time Physical Activity Questionnaire [5 months]
A 6-item scale asking participants the amount of time spent in light, moderate, and vigorous physical activity during the past week
- Hospital Anxiety and Depression Scale (HADS) [5 months]
14 item scale indicating levels of anxiety and depression in clinical populations. Higher scores indicate higher levels of anxiety and depression.
- Cardiac risk factors will be collected from medical history forms [5 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 - 80
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Primary cancer diagnosis of lymphoma
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Able and willing to participate in a supervised exercise program at the Anschutz Health and Wellness Center
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Provides a signed physician exercise clearance form
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SBP > 120 mmHg
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Completion of curative cancer treatment over 12 months prior (individuals on maintenance therapy will be included)
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Possession of a smartphone compatible with the IMST training application (available on both Android and Apple).
Exclusion Criteria:
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oSecond active cancer diagnosis
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oPlanned active cancer treatment or change in current treatment in the next 6 months
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Severe obesity (BMI > 40 kg/m2) or underweight (BMI < 18.5 kg/m2)
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Unstable weight (> 3 kg change in body mass in last 3 months)
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Significant metabolic disorder (e.g. diabetes type II)
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Uncontrolled thyroid disease
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Recent changes in hypertensive medication (within last 3 months)
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Greater than 100 min of self-reported regular exercise per week
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Any medical condition that would impact the safety of, or participation in, an exercise program, including:
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Significant pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, or interstitial lung disease
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Known cardiovascular disease, significant hypertension (> 180/120), or a recent cardiac event (within past 6 months)
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Orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries
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Advanced rheumatoid arthritis or chronic widespread pain conditions such as fibromyalgia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anschutz Health and Wellness | Aurora | Colorado | United States | 80045 |
| 2 | University of Colorado Cancer Center | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
Investigators
- Principal Investigator: Ryan Marker, PT, PhD, University of Colorado, Denver
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-1216.cc
- NCI-2023-03997