Evaluation of Functional and Nutritional Parameters in Fit Acute Leukemia Patients

NCT06937554 | Recruiting

• 1 other identifier: FisNutEma
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Leukemia

Keywords

Acute leukemia; Rehabiltation; Quality of life; Nutrition

Outcome Measures

Primary Outcomes (13)

• 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.

  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)

• 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

  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)

• 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.

  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)

• 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

  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)

• Visual Analogue Scale (VAS) for pain

  The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).

  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)

• Fatigue Severity Scale (FSS)

  The FSS questionnaire contains nine statements that rate the severity of fatigue symptoms. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. A total score of less than 36 suggests that the patient may not be suffering from fatigue. A total score of 36 or more suggests that the patient may need further evaluation by a physician.

  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)

• Functional Ambulation Classification (FAC)

  The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. A score of 0 indicates that the patient is a non-functional ambulator (cannot walk). A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3). A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score).

  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)

• SF-12 Questionnaire

  The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 uses eight domains: Limitations in physical activities because of health problems. Limitations in social activities because of physical or emotional problems Limitations in usual role activities because of physical health problems Bodily pain General mental health (psychological distress and well-being) Limitations in usual role activities because of emotional problems Vitality (energy and fatigue) General health perceptions

  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)

• Symbol Digit Modalities Test (SDMT) for processing speed

  The Symbol Digit Modalities Test (SDMT) is widely used for cognitive evaluation of information processing speed, required in many cognitive operations. The person taking the test is provided with a set of symbols, each corresponding to a number. He or she is required to write down the symbols corresponding to a series of numbers within a short space of time. The SDMT is quick (\~5 min) and straightforward to administer, provides a clear test score that is not influenced by subjective interpretations on the part of the healthcare professional who administers the test, and is little affected by patients׳ age, gender or educational status.

  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)

• Modified Barthel Index

  The Modified Barthel Index is an ordinal scale which measures a person's ability to complete activities of daily living. The evaluated domains are: * Feeding * Bathing * Grooming * Dressing * Bowel * Bladder * Toilet use * Transfers bed-to-chair-and-back * Mobility on level surfaces * Stair negotiation The higher the score, the more independent the patient is in completing the measured activity. Higher scores also indicate the patient is more likely to return home, with varying degrees of assistance, following hospital discharge. The lower the score, the more dependent the patient is with the activity completion, and the more skilled care will be required at discharge.

  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)

• Serum pre-albumine

  Serum prealbumin levels are measured using a blood test that can help assess nutritional status. Prealbumin is a protein made in the liver that helps transport thyroid hormones and vitamin A, and controls how the body uses energy. A prealbumin level below 30 mg/dL may indicate malnutrition.

  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

• Serum albumine

  A serum albumin test measures the amount of albumin in blood. Albumine dosage helps determining the presence of liver disease, kidney disease, or protein malabsorption. The normal range is 3.4 to 5.4 g/dL (34 to 54 g/L)

  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

• Body mass index (BMI)

  Body mass index (BMI) is a calculation that compares a person's weight to their height. It's a screening tool that can help determine if someone is a healthy weight for their height. BMI is calculated by dividing weight in kilograms by height in meters squared. BMI categories: Underweight: BMI is below 18.5 Healthy weight: BMI is between 18.5 and 24.9 Overweight: BMI is between 25 and 29.9 Obese: BMI is between 30 and 39.9 Severely obese: BMI is 40 or higher

  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 (5)

• Coin test

  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)

• Sock test

  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)

• Back Scratch Test

  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)

• Forward Bending Test

  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)

• Stability test

  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)

Study Arms (1)

Patients above 18 years, affected by Acute Leukemia, performing intensive chemotherapy

Other: observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters

Interventions

observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters OTHER

observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters

Patients above 18 years, affected by Acute Leukemia, performing intensive chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute Leukemia inpatients

You may qualify if:

• Age above 18 years
• Patients affected by Acute Leukemia
• Inpatients performing intensive chemotherapy
• Patients with no restrictions on mobilization
• Signed written informed consent in accordance with ICH/EU/GCP guidelines and national and local laws.

You may not qualify if:

• Age \<18 years
• Any medical condition that the attending doctor judges as limiting to perform study related tasks

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Tor Vergata university Hospital

Rome, RM, 00133, Italy

RECRUITING

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Central Study Contacts

Nicola Manocchio

CONTACT

+390620908594; nicola.manocchio@uniroma2.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student, Medical Doctor, PRM Specialist

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 22, 2025
• Study Start: April 10, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)