Trial Outcomes & Findings for Impact of Early Mobility on Post-Surgery Recovery in Patients Undergoing Oncologic Surgeries (NCT NCT04000581)

Results Overview

changes in mobility (as measured by average velocity of pelvis) from baseline to discharge are compared between groups using a one-sided, two-sample t-test.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

Baseline up to 30 days post discharge

Results posted on

2022-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Usual Care) Patients walk one to two laps around the ward twice per day, and have mobility tracked with Xsens over 5-10 minutes, until discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows. Best Practice: Receive standard of care Questionnaire Administration: Ancillary studies	Arm II (Additional Mobility) Patients walk for minimum 30 minutes per day and mobility is tracked with Xsens over 5-10 minutes up to discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows. Physical Activity: Walk for minimum 30 minutes per day Questionnaire Administration: Ancillary studies
Overall Study STARTED	5	12
Overall Study COMPLETED	5	11
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Usual Care) Patients walk one to two laps around the ward twice per day, and have mobility tracked with Xsens over 5-10 minutes, until discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows. Best Practice: Receive standard of care Questionnaire Administration: Ancillary studies	Arm II (Additional Mobility) Patients walk for minimum 30 minutes per day and mobility is tracked with Xsens over 5-10 minutes up to discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows. Physical Activity: Walk for minimum 30 minutes per day Questionnaire Administration: Ancillary studies
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

In the intervention arm, 2 patients have missing age. One patient removed their consent prior to any intervention.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Usual Care) n=5 Participants Patients walk one to two laps around the ward twice per day, and have mobility tracked with Xsens over 5-10 minutes, until discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows. Best Practice: Receive standard of care Questionnaire Administration: Ancillary studies	Arm II (Additional Mobility) n=12 Participants Patients walk for minimum 30 minutes per day and mobility is tracked with Xsens over 5-10 minutes up to discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows. Physical Activity: Walk for minimum 30 minutes per day Questionnaire Administration: Ancillary studies	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • In the intervention arm, 2 patients have missing age. One patient removed their consent prior to any intervention.	0 Participants n=10 Participants • In the intervention arm, 2 patients have missing age. One patient removed their consent prior to any intervention.	0 Participants n=15 Participants • In the intervention arm, 2 patients have missing age. One patient removed their consent prior to any intervention.
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants • In the intervention arm, 2 patients have missing age. One patient removed their consent prior to any intervention.	4 Participants n=10 Participants • In the intervention arm, 2 patients have missing age. One patient removed their consent prior to any intervention.	7 Participants n=15 Participants • In the intervention arm, 2 patients have missing age. One patient removed their consent prior to any intervention.
Age, Categorical >=65 years	2 Participants n=5 Participants • In the intervention arm, 2 patients have missing age. One patient removed their consent prior to any intervention.	6 Participants n=10 Participants • In the intervention arm, 2 patients have missing age. One patient removed their consent prior to any intervention.	8 Participants n=15 Participants • In the intervention arm, 2 patients have missing age. One patient removed their consent prior to any intervention.
Age, Continuous	63.2 years STANDARD_DEVIATION 5.8 • n=5 Participants • Two patients do not have age recorded.	67.7 years STANDARD_DEVIATION 8.4 • n=10 Participants • Two patients do not have age recorded.	66.2 years STANDARD_DEVIATION 7.8 • n=15 Participants • Two patients do not have age recorded.
Sex: Female, Male Female	0 Participants Sex was not recorded.	0 Participants Sex was not recorded.	0 Participants Sex was not recorded.
Sex: Female, Male Male	0 Participants Sex was not recorded.	0 Participants Sex was not recorded.	0 Participants Sex was not recorded.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	5 participants n=5 Participants	12 participants n=12 Participants	17 participants n=17 Participants
Godin Score	21.3 units on a scale STANDARD_DEVIATION 9.0 • n=4 Participants • The baseline Godin Score was not obtained for 4 subjects.	21.4 units on a scale STANDARD_DEVIATION 12.0 • n=9 Participants • The baseline Godin Score was not obtained for 4 subjects.	21.3 units on a scale STANDARD_DEVIATION 10.7 • n=13 Participants • The baseline Godin Score was not obtained for 4 subjects.

PRIMARY outcome

Timeframe: Baseline up to 30 days post discharge

Population: One patient (arm 2) removed consent prior to treatment initiation and outcome recording.

changes in mobility (as measured by average velocity of pelvis) from baseline to discharge are compared between groups using a one-sided, two-sample t-test.