Hodgkin LymphomaNCT05938127
Impact of Respiratory Training in Lymphoma Survivors
A study testing Inspiratory muscle strength training in people with Hodgkin Lymphoma and Non Hodgkin Lymphoma, run by University of Colorado, Denver at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hodgkin Lymphoma, Non Hodgkin Lymphoma
- What is being tested?
- Inspiratory muscle strength training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Sep 2024to 9 Dec 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Anschutz Health and Wellness
Aurora, Colorado, 80045
University of Colorado Cancer Center
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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
- Being tested
- Inspiratory muscle strength training, Sham Inspiratory muscle strength training
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle strength trainingDevice
Also called IMST
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
Sham Inspiratory muscle strength trainingDevice
Also called Sham IMST
Low-resistance inspiratory muscle strength training
| Study group | Role | What they receive |
|---|---|---|
| Pre-Randomization | Experimental | Participants who withdrew from the study prior to group randomization (prior to visit 2). Receives: Device: Inspiratory muscle strength training; Device: Sham Inspiratory muscle strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Participants Recruited
Count of number of participants recruited into the study
Measured: 12 weeks
Enrolled Participants Per Month
Average number of participants enrolled per month of the study
Measured: 12 weeks
Valid Assessments Per Participant
Adherence to 75% of the program will be deemed acceptable
Measured: 12 weeks
Session Attendance Per Participant
Adherence to 75% of the program will be deemed acceptable
Measured: 12 weeks
Total Participants Completing the Intervention
Adherence to 75% of the program will be deemed acceptable
Measured: 12 weeks
Systolic Blood Pressure
Resting systolic blood pressure, collected in triplicate at Visit 2.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 months
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start16 Sep 2024
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Why it stopped: Low Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Marker, PT, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938127
- Sponsor's protocol ID
- 22-1216.cc
- Other IDs
- NCI-2023-03997
- Status last verified
- Feb 2026
- First submitted
- 30 Jun 2023
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No