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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-03997 | Other Identifier | CTRP |
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Low Accrual
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Randomization | Experimental | Participants who withdrew from the study prior to group randomization (prior to visit 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
oSecond active cancer diagnosis
oPlanned active cancer treatment or change in current treatment in the next 6 months
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Marker, PT, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anschutz Health and Wellness | Aurora | Colorado | 80045 | United States | ||
| University of Colorado Cancer Center |
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Patient withdrew prior to randomization. No baseline measures were analyzed.
Recruitment and accrual lower than expected. One participant enrolled before study terminated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-Randomization | Participants who withdrew from the study prior to group randomization (prior to visit 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only one participant enrolled and subsequently withdrew before randomization. No baseline measures were analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-Randomization | Participants who withdrew from the study prior to group randomization. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Only one participant enrolled and subsequently withdrew. No baseline measures were analyzed. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Participants Recruited | Count of number of participants recruited into the study | Patient withdrew after visit one and prior to randomization. No baseline measures were analyzed. | Posted | Count of Participants | Participants | 12 weeks |
|
|
No participants were treated or analyzed; therefore, no adverse events were collected or reported.
No participants were treated or analyzed; therefore, no adverse events were collected or reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-Randomization | Participants who withdrew from the study prior to group randomization (prior to Visit 2). |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Marker | University of Colorado | 3037240819 | ryan.marker@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2024 | Nov 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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|
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| Sham Inspiratory muscle strength training | Device | Low-resistance inspiratory muscle strength training |
|
|
| 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. | 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. | 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. | 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. | 5 months |
| Aurora |
| Colorado |
| 80045 |
| United States |
Patient withdrew prior to randomization. No baseline measures were analyzed.
| Participants |
| No |
|
| Sex/Gender, Customized | Only one participant enrolled and subsequently withdrew. No baseline measures were analyzed. | Patient withdrew prior to randomization. No baseline measures were analyzed. | Participants | No |
|
| Race/Ethnicity, Customized | Only one participant enrolled and subsequently withdrew. No baseline measures were analyzed. | Patient withdrew prior to randomization. No baseline measures were analyzed. | Participants | No |
|
|
| Primary | Enrolled Participants Per Month | Average number of participants enrolled per month of the study | Participants who withdrew from the study prior to group randomization (prior to visit 2). | Posted | Number | participants | 12 weeks |
|
|
|
| Primary | Valid Assessments Per Participant | Adherence to 75% of the program will be deemed acceptable | Participants who withdrew from the study prior to group randomization (prior to visit 2). | Posted | Number | Assessments | 12 weeks |
|
|
|
| Primary | Session Attendance Per Participant | Adherence to 75% of the program will be deemed acceptable | Participants who withdrew from the study prior to group randomization (prior to visit 2). | Posted | Number | Sessions | 12 weeks |
|
|
|
| Primary | Total Participants Completing the Intervention | Adherence to 75% of the program will be deemed acceptable | Participants who withdrew from the study prior to group randomization (prior to visit 2). | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Primary | Systolic Blood Pressure | Resting systolic blood pressure, collected in triplicate at Visit 2. | Only one participant enrolled and subsequently withdrew prior to randomization (visit 2). Participant withdrew prior to collection of systolic blood pressure. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points. | Posted | 12 weeks |
|
|
| Secondary | 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. | Only one participant enrolled and subsequently withdrew. No non-feasibility measures were analyzed. | Posted | 12 weeks |
|
|
| Secondary | 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. | Only one participant enrolled and subsequently withdrew. No non-feasibility measures were analyzed. | Posted | 5 months |
|
|
| Secondary | 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. | Only one participant enrolled and subsequently withdrew. No non-feasibility measures were analyzed. | Posted | 5 months |
|
|
| Secondary | 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. | Only one participant enrolled and subsequently withdrew. No non-feasibility measures were analyzed. | Posted | 5 months |
|
|
| Secondary | 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. | Only one participant enrolled and subsequently withdrew. No non-feasibility measures were analyzed. | Posted | 5 months |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |