Impact of Respiratory Training in Lymphoma Survivors

Hodgkin Lymphoma Clinical Trial

Official title:

The Impact of Inspiratory Muscle Strength Training and Personalized Exercise Prescription on Metabolism, Cardiovascular Function, and Cardiorespiratory Fitness in Lymphoma Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938127
• Other study ID #: 22-1216.cc
• Secondary ID: NCI-2023-03997
• Status: Recruiting
• Phase: N/A
• Start date: December 2024
• Est. completion date: January 2026

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: Jared Scorsone
• Phone: 7207249601
• Email: jared.scorsone[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Lymphoma
• Lymphoma
• Non Hodgkin Lymphoma

Intervention

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
• Sham Inspiratory muscle strength training
Low-resistance inspiratory muscle strength training

Locations

Country	Name	City	State
United States	Anschutz Health and Wellness	Aurora	Colorado
United States	University of Colorado Cancer Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Participants Recruited	Count of number of participants recruited into the study	2 years
Primary	Enrolled Participants per Month	Average number of participants enrolled per month of the study	2 years
Primary	Valid Assessments per Participant	Adherence to 75% of the program will be deemed acceptable	5 months
Primary	Session Attendance per Participant	Adherence to 75% of the program will be deemed acceptable	5 months
Primary	Total Participants Completing the Intervention	Adherence to 75% of the program will be deemed acceptable	2 years
Primary	Systolic Blood Pressure	Resting systolic blood pressure, collected in triplicate	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months