Impact of Respiratory Training in Lymphoma Survivors

Not Applicable

Recruiting

• Conditions: Non Hodgkin Lymphoma; Hodgkin Lymphoma
• Interventions: Device: Sham Inspiratory muscle strength training; Device: Inspiratory muscle strength training

• Registration Number: NCT05938127
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-10
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-16
• Study Start: 2024-12
• Primary Completion: 2025-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lymphoma Survivors sham IMST	Sham Inspiratory muscle strength training	Participants will undergo a version of the BfitBwell Cancer Exercise Program physical assessment, which assesses physical fitness and function.
Lymphoma Survivors IMST	Inspiratory muscle strength training	Participants will undergo a version of the BfitBwell Cancer Exercise Program physical assessment, which assesses physical fitness and function.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.
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. Scores start at 0 with no upper range. Higher scores indicate more minutes of activity per week.
Molecular Markers - Acetylcholine-stimulated basal reactive oxygen species production	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. 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.
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.
Hospital Anxiety and Depression Scale (HADS)	5 months	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.
Molecular Markers - Acetylcholine-stimulated production of nitric oxide	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. 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.
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.
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.
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.

Trial Locations

Locations (2)

Anschutz Health and Wellness; 🇺🇸 Aurora, Colorado, United States

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States