A Phase 3 interventional study of Personalized Exercise Program in Non Small Cell Lung Cancer and Secondary Lung Cancer, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by University of Utah · Phase 3, Interventional, and Treatment
This is a Phase 3 study aimed at investigating the effects of a personalized exercise program (PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients undergoing surgical treatment at the University of Utah and comparing the intervention to the current standard of care (no exercise program).
This is a Phase 3 study aimed at investigating the effects of a personalized exercise program (PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients undergoing surgical treatment at the University of Utah and comparing the intervention to the current standard of care (no exercise program).
Eligible patients will be randomized between two arms (1:1 ratio) prior to the surgery and will be followed for approximately 6 months post-surgery:
Exclusion Criteria:
Behavioral: Personalized Exercise Program
The PEP intervention involves a combination of home-based exercise as well as in-patient exercise. The exercise modes will include basic transfer and calisthenics mobility, aerobic and resistance exercises and will be performed in various postures (supine, sitting, standing and walking) with variable challenges (level walking, bending, inclines, steps and squatting). For patients randomized to the Intervention Group (Group 1), the PEP intervention will be personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (\~30-40 minutes). An exercise education manual, specifically developed for this study, will be used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention.
Mobility Performance - Six Minute Walk (6MW) Distance
Six Minute Walk (6MW) distance is the distance patients can walk indoors on a 25-meter level, smooth-surfaced track over the course of 6 minutes. This outcome will report the mean 6MW distance at hospital discharge (up to 38 days after the initiation of the study intervention), at the 2-Month Post Surgery Visit (up to 5 months from the initiation of the study intervention), and at the 6-Month Post Surgery Visit (up to 9 months from the initiation of the study intervention).
Time frame: Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)
Evaluate the Change Short Physical Performance Battery (SPPB) Score
This outcome will report the results from the Short Physical Performance Battery (SPPB). This secondary outcome measure is associated with the evaluation of improvement in physical performance is the result of the short physical performance battery test. The SPPB score (ranging from 0 to 12) will be obtained for each patient at the time points described above. A score of 0 indicates the worst performance, and a score of 12 indicates the best performance. This outcome will report median SPPB scores at hospital discharge (up to 38 days after the initiation of the study intervention), at the 2-Month Post Surgery Visit (up to 5 months from the initiation of the study intervention), and at the 6-Month Post Surgery Visit (up to 9 months from the initiation of the study intervention).
Time frame: Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)
FACT-L (Functional Assessment of Cancer Therapy-Lung) Questionnaire
The FACT-L (Functional Assessment of Cancer Therapy-Lung) questionnaire assesses health-related quality of life (QOL). Total scores range from 0-136, with lower scores representing worse QOL and higher scores representing better QOL. This outcome measure will report mean FACT-L total scores at Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of the study therapy).
Time frame: Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of the study therapy)
Fatigue Subscale (FS)
This outcome will report the results of the Fatigue Subscale (FS) from the FACIT-F (Chronic Illness Fatigue Scale) questionnaire. The FACIT-F is a self-reported evaluation of fatigue in cancer patients. This questionnaire has patients rank statements regarding physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns from 0 Not at All to 4 Very Much. This outcome will report the FS score from the FACIT-F. The FS has a minimum of 0 and a maximum of 52; the higher the score the better the Quality of Life (QOL). The FS Score is calculated from 13 survey items. Individual items that were "reverse items" (meaning a high value indicates poor QOL) were subtracted from 4. Then all "reverse items" and normal items were added together to calculate the FS score. This assessment was scored according to the FACIT-F Scoring Guidelines (Version 4).
Time frame: Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
This outcome will report the results of the BREQ-3. The questionnaire has 24 items, each item ranging from 0 "Not True for Me" to 4 "Very True for Me". This questionnaire will report 6 sub-scores, Amotivation, External Regulation, Introjected Regulation, Identified Regulation, Integrated Regulation, Intrinsic Regulation. Each sub score is a the average of 4 items, ranging from 0-4 with higher values indicating higher motivation.
Time frame: Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)
| Milestone | Personalized Exercise Program | Standard of Care - No Exercise |
|---|---|---|
| Started | 92 | 90 |
| Completed | 82 | 85 |
| Not completed | 10 | 5 |
| Withdrew: Withdrawal by subject | 7 | 2 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Did not perform 6mw test | 3 | 2 |
| Milestone | Personalized Exercise Program | Standard of Care - No Exercise |
|---|---|---|
| Started | 82 | 85 |
| Completed | 82 | 82 |
| Not completed | 0 | 3 |
| Withdrew: Death | 0 | 3 |
Six Minute Walk (6MW) distance is the distance patients can walk indoors on a 25-meter level, smooth-surfaced track over the course of 6 minutes. This outcome will report the mean 6MW distance at hospital discharge (up to 38 days after the initiation of the study intervention), at the 2-Month Post Surgery Visit (up to 5 months from the initiation of the study intervention), and at the 6-Month Post Surgery Visit (up to 9 months from the initiation of the study intervention).
| meters | Personalized Exercise Program | Standard of Care - No Exercise |
|---|---|---|
| Hospital Discharge | 409.8 ± 169.8 | 411.0 ± 164.3 |
| 2-Month Post Surgery Visit | 490.5 ± 127.6 | 475.9 ± 129.5 |
| 6-Month Post Surgery Visit | 483.1 ± 151.9 | 463.3 ± 180 |
This outcome will report the results from the Short Physical Performance Battery (SPPB). This secondary outcome measure is associated with the evaluation of improvement in physical performance is the result of the short physical performance battery test. The SPPB score (ranging from 0 to 12) will be obtained for each patient at the time points described above. A score of 0 indicates the worst performance, and a score of 12 indicates the best performance. This outcome will report median SPPB scores at hospital discharge (up to 38 days after the initiation of the study intervention), at the 2-Month Post Surgery Visit (up to 5 months from the initiation of the study intervention), and at the 6-Month Post Surgery Visit (up to 9 months from the initiation of the study intervention).
| score on a scale | Personalized Exercise Program | Standard of Care - No Exercise |
|---|---|---|
| Hospital Discharge | 11 (9 to 12) | 11.5 (8.5 to 12) |
| 2-Month Post Surgery Visit | 12 (11 to 12) | 12 (10 to 12) |
| 6-Month Post Surgery Visit | 12 (11 to 12) | 12 (11 to 12) |
The FACT-L (Functional Assessment of Cancer Therapy-Lung) questionnaire assesses health-related quality of life (QOL). Total scores range from 0-136, with lower scores representing worse QOL and higher scores representing better QOL. This outcome measure will report mean FACT-L total scores at Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of the study therapy).
| score on a scale | Personalized Exercise Program | Standard of Care - No Exercise |
|---|---|---|
| Hospital Discharge | 100 ± 18.1 | 101.5 ± 17.0 |
| 2-Month Follow up | 106.4 ± 14.8 | 103.5 ± 17.1 |
| 6-Month Follow up | 106.5 ± 16 | 105.9 ± 15.7 |
This outcome will report the results of the Fatigue Subscale (FS) from the FACIT-F (Chronic Illness Fatigue Scale) questionnaire. The FACIT-F is a self-reported evaluation of fatigue in cancer patients. This questionnaire has patients rank statements regarding physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns from 0 Not at All to 4 Very Much. This outcome will report the FS score from the FACIT-F. The FS has a minimum of 0 and a maximum of 52; the higher the score the better the Quality of Life (QOL). The FS Score is calculated from 13 survey items. Individual items that were "reverse items" (meaning a high value indicates poor QOL) were subtracted from 4. Then all "reverse items" and normal items were added together to calculate the FS score. This assessment was scored according to the FACIT-F Scoring Guidelines (Version 4).
| score on a scale | Personalized Exercise Program | Standard of Care - No Exercise |
|---|---|---|
| Hospital Discharge | 34.5 ± 11.4 | 33.5 ± 12.1 |
| 2 Month Follow-up Visit | 38.6 ± 8.7 | 36 ± 10.7 |
| 6-Month Follow-up | 38.2 ± 10.2 | 37.5 ± 11.3 |
This outcome will report the results of the BREQ-3. The questionnaire has 24 items, each item ranging from 0 "Not True for Me" to 4 "Very True for Me". This questionnaire will report 6 sub-scores, Amotivation, External Regulation, Introjected Regulation, Identified Regulation, Integrated Regulation, Intrinsic Regulation. Each sub score is a the average of 4 items, ranging from 0-4 with higher values indicating higher motivation.
| score on a scale | Personalized Exercise Program | Standard of Care - No Exercise |
|---|---|---|
| Discharge: Amotivation | 0.2 ± 0.5 | 0.2 ± 0.5 |
| Discharge: External Regulation | 0.8 ± 1.1 | 0.9 ± 1.0 |
| Discharge: Introjected Regulation | 1.7 ± 1.1 | 1.7 ± 1 |
| Discharge: Identified Regulation | 2.9 ± .8 | 2.8 ± 0.9 |
| Discharge: Integrated Regulation | 2.2 ± 1.3 | 2.1 ± 1.2 |
| Discharge: Intrinsic Regulation | 2.3 ± 1.2 | 2.3 ± 1.2 |
| 2-Month: Amotivation | 0.1 ± 0.3 | 0.2 ± 0.4 |
| 2-Month: External Regulation | 0.8 ± 1 | 0.90 ± 1 |
| 2-Months: Introjected Regulation | 1.7 ± 1.1 | 1.7 ± 1.1 |
| 2-Months: Identified Regulation | 3.0 ± 0.7 | 2.9 ± 0.9 |
| 2-Months: Integrated Regulation | 2.2 ± 1.1 | 2.1 ± 1.2 |
| 2-Months: Intrinsic Regulation | 2.2 ± 1 | 2.3 ± 1.1 |
| 6-Months: Amotivation | 0.2 ± 0.4 | 0.3 ± 0.6 |
| 6-Months: External Regulation | 0.8 ± 1.0 | 0.8 ± 1.0 |
| 6-Months: Introjected Regulation | 1.9 ± 1.1 | 1.8 ± 1.2 |
| 6-Months: Identified Regulation | 3.1 ± 0.8 | 2.9 ± 0.9 |
| 6-Months: Integrated Regulation | 2.4 ± 1.2 | 2.3 ± 1.1 |
| 6-Months: Intrinsic Regulation | 2.4 ± 1.1 | 2.4 ± 1.2 |
Collected over Adverse event, Safety Adverse Event, and All Cause Mortality data were collected from the initiation of the study intervention to the Month 6 Follow-Up Visit, up to 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Personalized Exercise Program | 0/92 (0%) | 0/92 (0%) | 5/92 (5.4%) |
| Standard of Care - No Exercise | 4/90 (4.4%) | 0/90 (0%) | 0/90 (0%) |
| Event | Personalized Exercise Program | Standard of Care - No Exercise |
|---|---|---|
| Pain in extremityMusculoskeletal and connective tissue disorders | 2/92 | 0/90 |
| Muscle weakness lower limbMusculoskeletal and connective tissue disorders | 1/92 | 0/90 |
| Joint range of motion decreased cervical spineMusculoskeletal and connective tissue disorders | 1/92 | 0/90 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/92 | 0/90 |
| Joint range of motion decreasedMusculoskeletal and connective tissue disorders | 1/92 | 0/90 |
| Age, Continuous(years) | Personalized Exercise Program | Standard of Care - No Exercise | Total |
|---|---|---|---|
| Mean | 62.7 ± 14.7 | 62.7 ± 13.0 | 62.7 ± 13.8 |
| Sex: Female, Male(Participants) | Personalized Exercise Program | Standard of Care - No Exercise | Total |
|---|---|---|---|
| Female | 51 | 57 | 108 |
| Male | 41 | 33 | 74 |
| Ethnicity (NIH/OMB)(Participants) | Personalized Exercise Program | Standard of Care - No Exercise | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 6 | 10 |
| Not Hispanic or Latino | 86 | 83 | 169 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Personalized Exercise Program | Standard of Care - No Exercise | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 86 | 83 | 169 |
| More than one race | 1 | 2 | 3 |
| Unknown or Not Reported | 3 | 4 | 7 |
| Region of Enrollment(participants) | Personalized Exercise Program | Standard of Care - No Exercise | Total |
|---|---|---|---|
| United States | 92 | 90 | 182 |
| Rural-Urban Status(Participants) | Personalized Exercise Program | Standard of Care - No Exercise | Total |
|---|---|---|---|
| Urban | 82 | 75 | 157 |
| Rural | 10 | 15 | 25 |
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Carcinoma, Non-Small-Cell Lung→
University of Utah