Trial Outcomes & Findings for Impact of Respiratory Training in Lymphoma Survivors (NCT NCT05938127)
NCT ID: NCT05938127
Last Updated: 2026-02-27
Results Overview
Resting systolic blood pressure, collected in triplicate at Visit 2.
TERMINATED
NA
1 participants
12 weeks
2026-02-27
Participant Flow
Recruitment and accrual lower than expected. One participant enrolled before study terminated.
Patient withdrew prior to randomization. No baseline measures were analyzed.
Participant milestones
| Measure |
Pre-Randomization
Participants who withdrew from the study prior to group randomization (prior to visit 2)
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient withdrew prior to randomization. No baseline measures were analyzed.
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 12 weeksPopulation: Patient withdrew after visit one and prior to randomization. No baseline measures were analyzed.
Count of number of participants recruited into the study
Outcome measures
| Measure |
Pre-Randomization
n=1 Participants
Participants who withdrew from the study prior to group randomization (prior to visit 2).
|
|---|---|
|
Total Participants Recruited
|
1 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Participants who withdrew from the study prior to group randomization (prior to visit 2).
Average number of participants enrolled per month of the study
Outcome measures
| Measure |
Pre-Randomization
n=1 Participants
Participants who withdrew from the study prior to group randomization (prior to visit 2).
|
|---|---|
|
Enrolled Participants Per Month
|
NA participants
One participant consented but was never randomized. The study did not accrue any further patients and was closed due to low accrual.
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Participants who withdrew from the study prior to group randomization (prior to visit 2).
Adherence to 75% of the program will be deemed acceptable
Outcome measures
| Measure |
Pre-Randomization
n=1 Participants
Participants who withdrew from the study prior to group randomization (prior to visit 2).
|
|---|---|
|
Valid Assessments Per Participant
|
0 Assessments
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Participants who withdrew from the study prior to group randomization (prior to visit 2).
Adherence to 75% of the program will be deemed acceptable
Outcome measures
| Measure |
Pre-Randomization
n=1 Participants
Participants who withdrew from the study prior to group randomization (prior to visit 2).
|
|---|---|
|
Session Attendance Per Participant
|
0 Sessions
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Participants who withdrew from the study prior to group randomization (prior to visit 2).
Adherence to 75% of the program will be deemed acceptable
Outcome measures
| Measure |
Pre-Randomization
n=1 Participants
Participants who withdrew from the study prior to group randomization (prior to visit 2).
|
|---|---|
|
Total Participants Completing the Intervention
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
Resting systolic blood pressure, collected in triplicate at Visit 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Only one participant enrolled and subsequently withdrew. No non-feasibility measures were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 monthsPopulation: Only one participant enrolled and subsequently withdrew. No non-feasibility measures were analyzed.
Participants will be instructed to walk as far as possible in a six minute period on an indoor track.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 monthsPopulation: Only one participant enrolled and subsequently withdrew. No non-feasibility measures were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 monthsPopulation: Only one participant enrolled and subsequently withdrew. No non-feasibility measures were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 monthsPopulation: Only one participant enrolled and subsequently withdrew. No non-feasibility measures were analyzed.
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.
Outcome measures
Outcome data not reported
Adverse Events
Pre-Randomization
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place