Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06134297
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-18
First Post:
2023-10-16
Brief Title:
Adherence Viability Clinical Evolution and Therapeutic Efficacy in Patients Undergoing Bone Marrow Transplantation
Sponsor:
Federal University of Health Science of Porto Alegre
Organization:
Federal University of Health Science of Porto Alegre
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 clinicalbehavioral 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
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 05kg1kg 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 11 ratio until the end of the program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None