Clinical trial NCT05938127: 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
Overall status: TERMINATED
Phase: NA
Conditions: Hodgkin Lymphoma
Non Hodgkin Lymphoma
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Total Participants Recruited
timeFrame: 2 years
measure: Enrolled Participants per Month
timeFrame: 2 years
measure: Valid Assessments per Participant
timeFrame: 5 months
measure: Session Attendance per Participant
timeFrame: 5 months
measure: Total Participants Completing the Intervention
timeFrame: 2 years
measure: Systolic Blood Pressure
timeFrame: 5 months
Secondary outcomes:
measure: Molecular Markers - Acetylcholine-stimulated production of nitric oxide
timeFrame: 5 months
measure: Molecular Markers - Acetylcholine-stimulated basal reactive oxygen species production
timeFrame: 5 months
measure: Cardiorespiratory Fitness (CRF) will be assessed via estimated VO2max
timeFrame: 5 months
measure: Physical function primarily assessed by the 6MWT
timeFrame: 5 months
measure: Metabolomics analyses will be performed on blood samples
timeFrame: 5 months
measure: Functional Assessment of Cancer Therapy - General (FACT-G, assessing quality of life)
timeFrame: 5 months
measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue)
timeFrame: 5 months
measure: Godin Leisure Time Physical Activity Questionnaire
timeFrame: 5 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 5 months
measure: Cardiac risk factors will be collected from medical history forms
timeFrame: 5 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Anschutz Health and Wellness
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Ryan Marker, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: