Impact of Respiratory Training in Lymphoma Survivors

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

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 Overview

• Status: Terminated
• Conditions: Hodgkin Lymphoma; Non Hodgkin Lymphoma
• Intervention / Treatment: Device: Inspiratory muscle strength training; Device: Sham Inspiratory muscle strength training

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
    • Aurora, Colorado, United States, 80045
      • Anschutz Health and Wellness

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pre-Randomization; Participants who withdrew from the study prior to group randomization (prior to visit 2).

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; Other Names: IMST; Device: Sham Inspiratory muscle strength training; Low-resistance inspiratory muscle strength training; Other Names: Sham IMST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Participants Recruited	Count of number of participants recruited into the study	12 weeks
Enrolled Participants Per Month	Average number of participants enrolled per month of the study	12 weeks
Valid Assessments Per Participant	Adherence to 75% of the program will be deemed acceptable	12 weeks
Session Attendance Per Participant	Adherence to 75% of the program will be deemed acceptable	12 weeks
Total Participants Completing the Intervention	Adherence to 75% of the program will be deemed acceptable	12 weeks
Systolic Blood Pressure	Resting systolic blood pressure, collected in triplicate at Visit 2.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	12 weeks
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
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Ryan Marker, PT, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Actual): December 9, 2024
• Study Completion (Actual): December 9, 2024

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Non-Hodgkin; Hodgkin Disease
• Other Study ID Numbers: 22-1216.cc; NCI-2023-03997 (Other Identifier: CTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes