Impact of Respiratory Training in Lymphoma Survivors

NCT05938127 | Terminated Results DMC FDA Device

• 2 other identifiers: 22-1216.ccNCI-2023-03997
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Hodgkin Lymphoma; Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Cardiorespiratory Fitness (CRF) Will be Assessed Via Estimated VO2max

  12 weeks

• Physical Function Primarily Assessed by the 6MWT

  5 months

• Metabolomics Analyses Will be Performed on Blood Samples

  5 months

• Functional Assessment of Cancer Therapy - General (FACT-G, Assessing Quality of Life)

  5 months

• Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue)

  5 months

Study Arms (1)

Pre-Randomization

EXPERIMENTAL

Participants who withdrew from the study prior to group randomization (prior to visit 2).

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

Interventions

Inspiratory muscle strength training 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

Also known as: IMST

Pre-Randomization

Sham Inspiratory muscle strength training DEVICE

Low-resistance inspiratory muscle strength training

Also known as: Sham IMST

Pre-Randomization

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

Anschutz Health and Wellness

Aurora, Colorado, 80045, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

Study was terminated after enrolling only a single participant (not randomized) due to low accrual. The single participant withdrew from the study prior to group assignment. No valid results can be presented.

Results Point of Contact

• Title: Ryan Marker
• Organization: University of Colorado

ryan.marker@cuanschutz.edu

3037240819

Study Officials

• Ryan Marker, PT, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: September 16, 2024
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)