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Trial Title:
Impact of Respiratory Training in Lymphoma Survivors
NCT ID:
NCT05938127
Condition:
Hodgkin Lymphoma
Non Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
Single (Care Provider)
Intervention:
Intervention type:
Device
Intervention name:
Inspiratory muscle strength training
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
Arm group label:
Lymphoma Survivors IMST
Other name:
IMST
Intervention type:
Device
Intervention name:
Sham Inspiratory muscle strength training
Description:
Low-resistance inspiratory muscle strength training
Arm group label:
Lymphoma Survivors sham IMST
Other name:
Sham IMST
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.
Criteria for 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)
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anschutz Health and Wellness
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jared Scorsone
Phone:
720-724-9601
Email:
jared.scorsone@cuanschutz.edu
Contact backup:
Last name:
Ryan J Marker, PT, PhD
Facility:
Name:
University of Colorado Cancer Center
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jared Scorsone
Phone:
7207249601
Email:
jared.scorsone@cuanschutz.edu
Contact backup:
Last name:
Ryan Marker, PT, PhD
Start date:
December 2024
Completion date:
January 2026
Lead sponsor:
Agency:
University of Colorado, Denver
Agency class:
Other
Source:
University of Colorado, Denver
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05938127
