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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Show all 12Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Inspiratory Muscle Strength Training and Personalized Exercise Prescription on Metabolism, Cardiovascular Function, and Cardiorespiratory Fitness in Lymphoma Survivors
- ClinicalTrials.gov ID
- NCT05938127
- Acronym / sponsor ID
- 22-1216.cc
- Conditions
- Hodgkin Lymphoma, Non Hodgkin Lymphoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-Randomization | Experimental | Device: Inspiratory muscle strength training, Device: Sham Inspiratory muscle strength trainingParticipants who withdrew from the study prior to group randomization (prior to visit 2). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- oSecond active cancer diagnosis
- oPlanned active cancer treatment or change in current treatment in the next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle strength trainingAlso: IMSTHigh-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 | Device | Pre-Randomization |
| Sham Inspiratory muscle strength trainingAlso: Sham IMSTLow-resistance inspiratory muscle strength training | Device | Pre-Randomization |
Primary outcome
Total Participants Recruited
Time frame: 12 weeks
Count of number of participants recruited into the study
Enrolled Participants Per Month
Time frame: 12 weeks
Average number of participants enrolled per month of the study
Valid Assessments Per Participant
Time frame: 12 weeks
Adherence to 75% of the program will be deemed acceptable
Session Attendance Per Participant
Time frame: 12 weeks
Adherence to 75% of the program will be deemed acceptable
Total Participants Completing the Intervention
Time frame: 12 weeks
Adherence to 75% of the program will be deemed acceptable
Systolic Blood Pressure
Time frame: 12 weeks
Resting systolic blood pressure, collected in triplicate at Visit 2.
5 secondary outcomes
Cardiorespiratory Fitness (CRF) Will be Assessed Via Estimated VO2max
Time frame: 12 weeks
Physical Function Primarily Assessed by the 6MWT
Time frame: 5 months
Metabolomics Analyses Will be Performed on Blood Samples
Time frame: 5 months
Functional Assessment of Cancer Therapy - General (FACT-G, Assessing Quality of Life)
Time frame: 5 months
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue)
Time frame: 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Marker, PT, PhD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Participants Recruited (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.