Evaluation of Functional and Nutritional Parameters in Fit Acute Leukemia Patients
ConditionAcute Leukemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorUniversity of Rome Tor Vergata
About this trial
This single-center observational prospective longitudinal study will assess cognitive, physical, and nutritional performance in acute leukemia patients undergoing intensive chemotherapy. Patients will provide informed consent prior to enrollment. Hematologists will oversee clinical management and approve evaluations, while physical and rehabilitation medicine specialists and a nutritionist will conduct assessments. Performance will be evaluated at admission, discharge, and three weeks (21 days) after starting chemotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age above 18 years
Patients affected by Acute Leukemia
Inpatients performing intensive chemotherapy
Patients with no restrictions on mobilization
Disqualifiers
Age <18 years
Any medical condition that the attending doctor judges as limiting to perform study related tasks
Trial population
Acute Leukemia inpatients
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters
Other interventionobservational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Patients above 18 years, affected by Acute Leukemia, performing intensive chemotherapy1 intervention
Trial outcomes
Primary outcomes
1
Grip Force Test
A grip force test using a dynamometer, also known as a handgrip dynamometer, measures how much force a person can apply with their fingers and forearms. It's a tool used to assess hand grip strength.
Time frame
Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)2
Modified Borg Scale (MBS)
The MBS is a subjective rating scale used to measure the intensity of physical activity. It ranges from 6 to 20 points, with 6 representing "no exertion" and 20 representing "maximal exertion." The scale is divided into four categories: 6-9 (very light), 10-12 (light), 13-15 (somewhat hard), and 16-20 (very hard). The MBS is commonly used to assess the intensity of exercise and to monitor individual responses to physical activity. It can be used by people of all ages and fitness levels
Time frame
Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)3
Tampa Scale of Kinesofobia (TSK)
Individual item scores range from 1-4, with the negatively worded items (4,8,12,16) having a reverse scoring (4-1). The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
Time frame
Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)4
Timed Up and Go (TUG)
Measure of function which correlates to balance and fall risk. Start timing on the word "GO" and stop timing when the subject is seated again correctly in the chair with their back resting on the back of the chair. ≤ 10 seconds = normal ≤ 20 seconds = good mobility, can go out alone, mobile without gait aid ≤ 30 seconds = problems, cannot go outside alone, requires gait aid \* A score of ≥ 14 seconds has been shown to indicate high risk of falls
Time frame
Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)Secondary outcomes
1
Coin test
For this test, subjects sit at a table and are timed as they pick up four coins (2€, 50cents, 10cents, 5cents ) and place them in a cup. They are required to pick up each coin individually.
Time frame
Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)2
Sock test
Subjects sit in a standard chair. They are timed as putting on one sock
Time frame
Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)3
Back Scratch Test
distance between the two middle fingers, one arm from above and one from below behind the back
Time frame
Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)4
Forward Bending Test
distance between middle fingers and ground
Time frame
Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)Sponsors and contacts
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Source ClinicalTrials.gov