Effect of the Cycloergometer in Patients Undergoing Hematopoietic Stem Cell Transplantation

NCT04496011 | Unknown DMC

• 1 other identifier: TMO 2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Physiological changes caused by hematological diseases associated with high dose chemotherapy have a negative impact on patient's functionality, making them more fragile and vulnerable after hematopoietic cell transplantation. Currently, randomized studies have shown that physical exercise can contribute to improve Quality of Life of these patients. In this randomized controlled trial, we will study the effect of using the bicycle ergometer on the physical performance of patients undergoing transplantation of hematopoietic stem cells (HSCT).

Conditions

Fatigue; Leukemia; Lymphoma; Multiple Myeloma; Hematopoietic Stem Cell Transplantation

Keywords

Autologous transplant; Allogeneic transplant; Physiotherapy; Exercise; Fatigue

Outcome Measures

Primary Outcomes (1)

• Lower Limb Physical Functioning and Strength

  The 30-Second Chair Stand evaluates lower limb strength and, indirectly, the risk of falls, especially in the elderly population (JONES, J., RIKLI, 2002). This way, it will compose the set of tests used to determine the physical performance by measuring the number of stands from an armless chair of standard height (45 cm) performed in 30 seconds. The test will be begin when the participant, seating on a neutral spine position and feet flat on the floor, will be instructed to rise to a full stand and return to the original seated position, as quickly as possible. The participant will be instructed to move at maximal speed until they either feel the need to stop or the 30-second time limit is reached. More than 8 unassisted stands for men and women are considered above average for their age, and those below the range as below average

  Trough study completion, an average of 2 months

Secondary Outcomes (3)

• Fatigue

  Trough study completion, an average of 2 months

• Symptoms Assessment

  Trough study completion, an average of 2 months

• Timed up and Go (TUG)

  Trough study completion, an average of 2 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

In this group the exercise program will be based on the protocol of Control Group, without the exception of walking training, adding aerobic capacity training using the bicycle ergometer, model CBL11 Classic® from ACT®.

Other: Aerobic training with cycle ergometer

Group Control

NO INTERVENTION

In this group the exercise program is based on the standard physiotherapy protocol that is part of the care routines performed at the bone marrow transplant service. It includes essential components of a rehabilitation program: range of motion, balance training, gait and strength of the upper and lower limbs

Interventions

Aerobic training with cycle ergometer OTHER

Patients start with an initial warm-up of 2 minutes, with rotations per minute free, without load. Progressively, the load of the exercise cycle increases every minute up to the supported limit or up to 60% - 70% of maximum heart rate (HRmax). The training will be carried out for 20 continuous minutes, being interrupted whenever the heart rate (HR) reaches 90% of the maximum expected for the age and / or the loss of effort perceived in the BORG scale, above 8 on a scale of 0 to 10.

Experimental Group

Eligibility Criteria

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

You may qualify if:

• Adult patients (18-70 years) scheduled to perform the first HSCT;
• Be with a preserved neurological function and full cognition;
• Have clinical conditions that allow participation in the motor physiotherapy program;
• Be agreed with a study proposal and sign the free and informed consent form (ICF).

You may not qualify if:

• Develop clinical complications that contraindicate the performance of motor physiotherapy including the practice of the cycle ergometer;
• Present a previous musculoskeletal alteration that interferes with the performance of physical performance assessment tests;
• Recent cardiovascular or pulmonary disease;
• Psychiatric or neurological disorder;
• Need for gait assistance or presence of bone metastasis
• Adherence below 50% of the total motor physiotherapy protocol.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

RECRUITING

MeSH Terms

Conditions

Fatigue; Leukemia; Lymphoma; Multiple Myeloma; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Behavior

Study Officials

• Fabricio Edler Macagnan, PhD

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabricio Edler Macagnan, PhD

CONTACT

+55 (51) 3309.8876; fabriciom@ufcspa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: Patients will be included by convenience (according to the inclusion and exclusion criteria) in non-probabilistic form. The included individuals will be randomized by (nome do Sofwate) in two lists: one for the control group and other for the experimental group. Once defined that the patient will be part of the experimental group, a bicycle ergometer will be kept in the patient's accommodation during the period of hospitalization due to restrictions imposed by the Infection Control Department. Thus, the equipment will remain in the patient´s room during the hospitalization, while the other patients will be allocated to the control group.

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: August 3, 2020
• Study Start: March 2, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 1, 2020
• Last Updated: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)