Hodgkin Lymphoma, Non Hodgkin Lymphoma
Conditions
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.
Interventions
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
DEVICESham Inspiratory muscle strength training
Low-resistance inspiratory muscle strength training
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Participants Recruited | 12 weeks | Count of number of participants recruited into the study |
| Enrolled Participants Per Month | 12 weeks | Average number of participants enrolled per month of the study |
| Valid Assessments Per Participant | 12 weeks | Adherence to 75% of the program will be deemed acceptable |
| Session Attendance Per Participant | 12 weeks | Adherence to 75% of the program will be deemed acceptable |
| Total Participants Completing the Intervention | 12 weeks | Adherence to 75% of the program will be deemed acceptable |
| Systolic Blood Pressure | 12 weeks | Resting systolic blood pressure, collected in triplicate at Visit 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiorespiratory Fitness (CRF) Will be Assessed Via Estimated VO2max | 12 weeks | 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. Scores range from 0-108 with 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. Scores range from 0-52 with higher scores indicate lower levels of fatigue. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRyan Marker, PT, PhD
University of Colorado, Denver
Participant flow
Recruitment details
Recruitment and accrual lower than expected. One participant enrolled before study terminated.
Pre-assignment details
Patient withdrew prior to randomization. No baseline measures were analyzed.
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
None listed