Impact of Respiratory Training in Lymphoma Survivors

University of Colorado Denver (CU Denver)

Status: Terminated

Conditions: Hodgkin Lymphoma; Non Hodgkin Lymphoma

Treatments: Device: Inspiratory muscle strength training; Device: Sham Inspiratory muscle strength training

Study type: Interventional

Funder types: Other

Identifiers

NCT05938127

22-1216.cc

NCI-2023-03997 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1 participants in 2 patient groups

Lymphoma Survivors IMST

Experimental group

Description:

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

Treatment:

Device: Inspiratory muscle strength training

Lymphoma Survivors sham IMST

Experimental group

Description:

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

Treatment:

Device: Sham Inspiratory muscle strength training