Impact of Respiratory Training in Lymphoma Survivors

NCT ID: NCT05938127

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-16
• Study Completion Date: 2024-11-14

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.

Conditions

Hodgkin Lymphoma; Non Hodgkin Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Lymphoma Survivors IMST

Participants will undergo a version of the BfitBwell Cancer Exercise Program physical assessment, which assesses physical fitness and function.

Group Type: EXPERIMENTAL

Inspiratory muscle strength training

Intervention Type: DEVICE

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

Lymphoma Survivors sham IMST

Participants will undergo a version of the BfitBwell Cancer Exercise Program physical assessment, which assesses physical fitness and function.

Group Type: EXPERIMENTAL

Sham Inspiratory muscle strength training

Intervention Type: DEVICE

Low-resistance inspiratory muscle strength training

Interventions

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

Intervention Type: DEVICE

Sham Inspiratory muscle strength training

Low-resistance inspiratory muscle strength training

Intervention Type: DEVICE

Other Intervention Names

IMST; Sham IMST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Marker, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Anschutz Health and Wellness

Aurora, Colorado, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Countries

United States

Other Identifiers

NCI-2023-03997

Identifier Type: OTHER

Identifier Source: secondary_id

22-1216.cc

Identifier Type: -

Identifier Source: org_study_id