Adherence, Viability, Clinical Evolution and Therapeutic Efficacy in Patients Undergoing Bone Marrow Transplantation

Sponsor

Federal University of Health Science of Porto Alegre (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06134297

Collaborator

(none)

Enrollment

Location

Arms

32.9

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hematological neoplasms originate from the differentiation and proliferation of abnormal lymphatic or myeloid cells that alter the constitution of elements of the blood, bone marrow and lymph nodes. Treatment includes high-dose chemotherapy alone or associated with hematopoietic stem cell transplantation (HSCT). However, the adverse effects of this treatment affect multiple organs and systems, reducing physical capacity, increasing the feeling of fatigue, anxiety and depression, which together affect quality of life. Patients who exercise before, during or after anti-neoplastic treatment demonstrate significant benefits. But rehabilitating physical capacity involves the challenge of fluctuations in the patient's readiness along with daily clinical variations, which ultimately directly affects the rate of adherence to exercises, impacting the effectiveness of the physical rehabilitation program. There is no specific individualization of muscular overload that takes into account such variability in pathophysiological, functional and psychological situations, but the cardiorespiratory response and muscular strength performance in the face of progressive overload can be measured with sufficient recovery periods to optimize the physiological adaptations promoted by muscular overload. regularly, even in patients undergoing antineoplastic treatment. Objective: To evaluate the adherence rate, operational feasibility, clinical/behavioral evolution and effectiveness of three different muscle overload models (aerobic, anaerobic and mixed) used for the physical rehabilitation of patients hospitalized for antineoplastic hematological treatment with HSCT

Condition or Disease	Intervention/Treatment	Phase
Stem Cell Transplantation	Device: Cycle ergometer Device: Strength Training - elastic band and shin guards Device: Cycle ergometer, elastic band and shin guards	N/A

Detailed Description

This is a randomized clinical trial. Patients will be allocated into groups (1) Aerobic; (2) Anaerobic and (3) Mixed. The manifestation of signs and symptoms will be evaluated using the Edmonton Symptom Assessment System (ESAS) inventory, a sensation of fatigue using the multidimensional fatigue questionnaire (MIF), and quality of life using the European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire. Questionnaire (EORTC QLQ-30) and the incidence and intensity of anxiety and depression symptoms using the General Hospital Anxiety and Depression Scale (HAD), in addition to the strength assessment of the upper limbs (HANDGRIP) and lower limbs (TSL). Participants in the aerobic group will perform exercises for the lower limbs with a cycle ergometer for 15 consecutive minutes and participants in the anaerobic group will perform exercises with an overload of shin weights or dumbbells of 0.5kg/1kg for large muscle groups. Participants in the mixed group will have a mixed muscular overload, performed by alternating between aerobic and anaerobic overload with a 1:1 ratio until the end of the program.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

93 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Adherence, Feasibility, Clinical Evolution Therapeutic Efficacy of Three Different Muscle Overload Models Used for Physical Rehabilitation of Patients Undergoing Bone Marrow Transplantation: a Randomized Clinical Trial

Actual Study Start Date :

Mar 7, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aerobic Exercise Group Aerobic exercise using a cycle ergometer lasting 15 consecutive minutes with load adjusted to maintain heart rate (HR) between 65-75% of the maximum HR predicted for age (HRmax = 200-age).	Device: Cycle ergometer The Aerobic Exercise Group will perform a cycle ergometer for 15 consecutive minutes with a load adjusted to maintain heart rate (HR) between 65-75% of the maximum HR predicted for age (HRmax = 200-age). Peripheral oxygen saturation will be controlled and, upon a sustained drop (> 2 minutes after load reduction) below 90%, the session will be interrupted. The subjective feeling of tiredness in the legs and shortness of breath will be constantly monitored and if values equal to or greater than 8 (0-10) occur, the exercise will be stopped.
Experimental: Anaerobic Exercise Group Muscle strength training using shin guards and elastic bands to promote muscle overload, generating maximum force production, where the contraction time should not exceed 20 seconds.	Device: Strength Training - elastic band and shin guards The Anaerobic Exercise Group will perform muscular strength training using maximum strength, where the contraction time should not exceed 20 seconds. For the upper limbs, the overload used will be through the use of an elastic band, with guidance for the patient to perform the shoulder external rotation exercise, elbow flexion exercises and open row rowing exercise. For the lower limbs, bridge movements, lunges and sit-up exercises will be performed with a maximum of 15 repetitions, and overload with ankle weights or dumbbells can be used in addition to body weight. The muscle contraction should lead the patient to a state of muscular fatigue and if the objective is not achieved, the exercise will be adapted to require greater strength from the patient so that he or she can reach maximum strength.
Experimental: Mixed Exercise Group Exercises through alternation between aerobic and anaerobic overload (performing the exercises from the previously mentioned groups on alternate days), in a 1:1 ratio until the end of the physical rehabilitation program.	Device: Cycle ergometer, elastic band and shin guards Mixed Exercise Group will perform the exercises by alternating between aerobic and anaerobic overload, in a 1:1 ratio until the end of the physical rehabilitation program, following exactly the same protocols described previously (alternating one session of the aerobic protocol and in the following session the anaerobic protocol).

Arm

Intervention/Treatment

Experimental: Aerobic Exercise Group

Aerobic exercise using a cycle ergometer lasting 15 consecutive minutes with load adjusted to maintain heart rate (HR) between 65-75% of the maximum HR predicted for age (HRmax = 200-age).

Device: Cycle ergometer

The Aerobic Exercise Group will perform a cycle ergometer for 15 consecutive minutes with a load adjusted to maintain heart rate (HR) between 65-75% of the maximum HR predicted for age (HRmax = 200-age). Peripheral oxygen saturation will be controlled and, upon a sustained drop (> 2 minutes after load reduction) below 90%, the session will be interrupted. The subjective feeling of tiredness in the legs and shortness of breath will be constantly monitored and if values equal to or greater than 8 (0-10) occur, the exercise will be stopped.

Experimental: Anaerobic Exercise Group

Muscle strength training using shin guards and elastic bands to promote muscle overload, generating maximum force production, where the contraction time should not exceed 20 seconds.

Device: Strength Training - elastic band and shin guards

The Anaerobic Exercise Group will perform muscular strength training using maximum strength, where the contraction time should not exceed 20 seconds. For the upper limbs, the overload used will be through the use of an elastic band, with guidance for the patient to perform the shoulder external rotation exercise, elbow flexion exercises and open row rowing exercise. For the lower limbs, bridge movements, lunges and sit-up exercises will be performed with a maximum of 15 repetitions, and overload with ankle weights or dumbbells can be used in addition to body weight. The muscle contraction should lead the patient to a state of muscular fatigue and if the objective is not achieved, the exercise will be adapted to require greater strength from the patient so that he or she can reach maximum strength.

Experimental: Mixed Exercise Group

Exercises through alternation between aerobic and anaerobic overload (performing the exercises from the previously mentioned groups on alternate days), in a 1:1 ratio until the end of the physical rehabilitation program.

Device: Cycle ergometer, elastic band and shin guards

Mixed Exercise Group will perform the exercises by alternating between aerobic and anaerobic overload, in a 1:1 ratio until the end of the physical rehabilitation program, following exactly the same protocols described previously (alternating one session of the aerobic protocol and in the following session the anaerobic protocol).

Outcome Measures

Primary Outcome Measures

Effectiveness of the physical rehabilitation program for lower limb strength through sitting and standing exercises [During the period of hospital stay, an average 1 month.]
It will be determined by evaluating lower limb strength performance in the 30-second sit-to-stand test. The score will be based on the number of repetitions performed during the 30 timed seconds.
Effectiveness of the physical rehabilitation program for upper limb strength using dynamometry [During the period of hospital stay, an average 1 month]
It will be determined by evaluating the strength performance of the upper limbs through dynamometry. The value will be given in kilograms of force. And it will be calculated through the average of three measurements.
Adherence to physical rehabilitation sessions [During the period of hospital stay, an average 1 month]
It will be evaluated through the ratio between the number of sessions actually carried out by the number of days in which the minimum clinical conditions for practicing physical exercise can be fully characterized during the hospital admission.
Operational viability for implementing the exercise protocol [During the period of hospital stay, an average 1 month]
It will be evaluated through the time needed to execute the different muscle overload protocols
Satisfaction with physiotherapy care [During the period of hospital stay, an average 1 month]
It will be evaluated through a satisfaction questionnaire (contains 11 questions and a maximum score of 55 points; the higher the score, the better the test result and better satisfaction).
Clinical behavioral evolution of signs and symptoms related to cancer [During the period of hospital stay, an average 1 month]
The following will be carried out at the beginning and end of the intervention: - Edmonton Sympton Assessment System Inventory (scale with 9 items; each can be scored from 0 to 10; the final value of the scale is the sum of each item; the higher the score, the worse the symptoms).
Clinical behavioral evolution of signs of fatigue [During the period of hospital stay, an average 1 month]
The following will be carried out at the beginning and end of the intervention: - Multidimensional Fatigue Questionnaire - (20 questions scored from 1 to 5; the higher the final score, the worse the symptoms).
Clinical behavioral evolution of signs of anxiety and depression [During the period of hospital stay, an average 1 month]
The following will be carried out at the beginning and end of the intervention: - General Hospital Anxiety and Depression Scale (14 questions, scored from 0 to 3; the higher the final score, the worse the symptoms).
Clinical behavioral evolution of quality of life perception [During the period of hospital stay, an average 1 month]
The following will be carried out at the beginning and end of the intervention: - Basic Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer (30 questions scored from 1 to 4; the higher the final score, the worse the symptoms).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Be between 18 and 64 years old;
Present hematological malignancy undergoing first antineoplastic treatment with HSCT;
Have intact neurological function and cognition;
Be in clinical conditions that allow participation in physical rehabilitation;
To agree with the study proposal by signing the Free and Informed Consent Form (TCLE).

Exclusion criteria:

Present clinical complications that impair the performance of motor physiotherapy, including the practice of cycle ergometer and resistance exercises;
Present previous musculoskeletal changes that interfere with the execution of physical performance assessment tests;
Patients with limiting cardiovascular or pulmonary disease, significant psychiatric or neurological disorders and/or limiting interpretation of documents and forms that will be used in the study;
Patients who require mobility assistance and/or diagnosed with multiple myeloma with or without the presence of bone metastasis;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	RS	Brazil	90020-090

Sponsors and Collaborators

Federal University of Health Science of Porto Alegre

Investigators

Principal Investigator: Fabricio E Macagnan, Federal University of Health Science of Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Fabrício Edler Macagnan, Principal Investigator, Federal University of Health Science of Porto Alegre

ClinicalTrials.gov Identifier:

NCT06134297

Other Study ID Numbers:

54240221.5.0000.5335

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fabrício Edler Macagnan, Principal Investigator, Federal University of Health Science of Porto Alegre

Exercise Therapy

Fatigue

Hematologic Neoplasms

Study Results

No Results Posted as of Nov 18, 2023