Effectiveness Rehabilitation Hematopoietic Transplantation (ovERsHOT)

NCT ID: NCT03324620

Last Updated: 2017-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-12
• Study Completion Date: 2017-09-15

Brief Summary

The objective of the study is to evaluate the benefits and costs of a comprehensive rehabilitation program (physical, psychological, social and educational) for patients receiving hematopoietic stem cell transplantation (HSCT). It is a prospective longitudinal study with a control group. Patients will be included who will perform a transplant in the hospital environment. The variables of the study will be: number and type of complications, days of hospitalization, readmissions, economic cost of the program, exercise tolerance, assessment of muscular atrophy, health related quality of life, knowledge and self-management of the disease, all of them adjusted for the variables age, sex and hematological disease, as well as comorbidities. The evaluations will be performed before transplantation (between one and three months before), during the conditioning phase (intensive chemotherapy), before discharge, after immediate discharge and after discharge up to one year. The nursing team will perform the patient's therapeutic education, stimulation for physical activity, as well as evaluation and follow-up measures. Early detection of the needs of the rest of the rehabilitation team will be carried out. There will be a support function for the physiotherapist in regard to physical activity. In Spain there is no interdisciplinary team that provides comprehensive care and rehabilitation to this type of patients and few studies are dedicated to rehabilitation beyond physiotherapy as a preventive tool for future disabilities.

Detailed Description

Working hypothesis

• 1. Patients who receive a Hematopoietic Stem Cell Transplantation (HSCT) who follow a comprehensive rehabilitation program, have fewer post-transplant complications, reduce the number of hospital stay days, and return to their daily lives more quickly.
• 2. The economic costs derived from the incorporation of the rehabilitation program will be lower than the savings caused by the decrease in complications, hospital stay and consumption of health resources.

Goals

Main objectives

• To evaluate the quality of life related to health in the hematological patient who has received a HSCT and on which a new preventive functional rehabilitation intervention (other than physiotherapy) is applied.
• To compare the number and type of respiratory and other complications after HSCT among the intervention group compared to a control group.
• Estimate the effects of the rehabilitation program on tolerance to exercise in the short, medium and long term, as well as detect the change in lifestyle if this occurred.

Secondary objectives

• Evaluate and compare the days of hospital stay and the time elapsed in each of the specialized units (insulation, Intensive Care Unit, single room with High Efficiency Particulate Air, (HEPA filter).
• To qualify the economic costs of the physiotherapy intervention within the rehabilitation program, the complications and the days of hospitalization.
• To evaluate the incidence of muscular atrophy and the level of tolerance to the effort as indicative of physical deconditioning and sedentary lifestyle.
• Measure the amount of symptoms, or the frequency of them: pain (measured by visual analog scale for pain (VAS), nausea / vomiting, insomnia, anxiety, anorexia ...)

Methodology

This is a prospective experimental study with a control group prior to the start of the intervention, which will include 190 participants. The sample size was calculated using a 95% confidence level and considering a positive and negative variability of 50% since there are no previous studies applying this methodology and taking into account the high mortality associated with the infection that oscillates between 35 and 50% according to the studies. The subjects will be treated in the hospital setting in airtight rooms with HEPA filters. Patients will be collected correlatively from the moment they enter the transplant program and sign informed consent. The control group will be collected retrospectively, from the day 1 of the startup of the program to 75, after verifying that they do not meet any inclusion criteria. Recruitment and incorporation into the study will be continuous according to the appearance of cases that meet the inclusion criteria.

The study will include patients receiving HSCT for the next 2 years from the study start date and will be followed and evaluated for a period of one year after transplantation.

Outcomes:

Quality of life, post-transplant complications, especially respiratory, capacity for exercise tolerance, muscular atrophy, onset of sleep disorders, days of stay in different hospital units, cost of interventions: physiotherapy, treatment of complications, and program rehabilitation. Mortality related to the transplantation, which covers any lethal complication from the moment of conditioning and without intervening the patient's underlying disease, that is, the progression of the same. Assess adherence to the program and evaluation and knowledge acquired by the patient.

Measurements:

To make the measurements, use:

• Bioimpedance analysis body composition (BIA), (Quantum X, RJL-Systems instruments™, Mi, USA): This test is performed on the patients in the intervention group at baseline, at discharge from hospital for transplantation, at the month of discharge, and at 3, 6, and 12 months, in order to assess their body composition, their fat mass and their muscle mass.
• Six-minute-walk test (to complement the assessment of exercise tolerance): This test is performed on the patients in the intervention group at baseline, at discharge from hospital for transplantation, at the month of discharge, and at 3, 6, and 12 months, in order to assess the exercise tolerance described in meters traveled, percentage of normality, symptomatology (dyspnea / fatigue of legs), and heart rate recovery. The abrupt weight changes in this population will be decisive for the interpretation of these data.
• Muscle strength test (handgrip (Jamar™ Dynamometer, Preston, Jackson, Mi, USA) and 1RM): This test is performed on the patients in the intervention group at baseline, at discharge from hospital for transplantation, at the month of discharge, and at 3, 6, and 12 months, in order to assess the strength in upper limbs at different times of process.
• Functional Assessment of Cancer Therapy questionnaires (FACT) validated in Spanish, to measure quality of life associated with the disease (lymphoma (LYM), leukemia (LEU), multiple myeloma (MM), Bone marrow transplantation (BMT); fatigue, anorexia): This test is performed on the patients in the intervention group at baseline, at discharge from hospital for transplantation, at the month of discharge, and at 3, 6, and 12 months in order to evaluate subjectively different aspects of health: functional, physical, emotional, as well as other concerns and symptoms associated with the process.
• Physical activity questionnaire for adult subjects -Modified Baecke Questionnaire™- (to measure the sedentary lifestyle): This test is performed on the patients in the intervention group at baseline, at discharge from the transplant hospital, at the month of discharge, and at 3, 6, and 12 months, in order to subjectively assess physical activity which subjects can develop during the first year of the transplant, and if there are limitations due to complications or readmissions.
• Anxiety-depression assessment (HAD) questionnaire. This test is performed on patients in the intervention group at baseline, at discharge from the transplant hospital, at the month of discharge, and at 3, 6, and 12 months, in order to assess the role of anxiety and depression at different times of the transplant and its follow-up in one year.
• Pittsburgh Sleep Quality Index. This test is performed on the patients in the intervention group at baseline, at discharge from the transplant hospital, at the month of discharge, and at 3, 6, and 12 months, in order to assess the subjective quality of sleep in these patients during the transplant period and their follow-up for one year. It is intended to evaluate the previous present difficulties, the use of hypnotics or other drugs used, and the need for continuity of treatments, as well as the effectiveness of them. The quality of sleep in hospitalized patients is highly documented, but it is not present in this type of patients nor is there any longitudinal follow-up.

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

physiotherapy; nurse; Cost effectiveness; Activities of Daily Living; exercise tolerance; Allogeneic; Quality of Life; Rehabilitation; Physical Activity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

pre active HSCT

Candidates for transplantation of hematopoietic progenitors since May 12, 2012, regardless of sex and age, who agree to participate in the study and sign informed consent.

In the pre-transplantation visit with the physiotherapist: Measures of muscle mass and strength, quality of life questionnaires, program presentation, fitness assessment and lifestyle determination. The exercises will be personalized, stimulating your practice before admission and involving the family. During admission, the team will encourage the patient to remain active by adapting to the symptoms. At discharge, measures of resistance, exercise tolerance and quality of life at discharge, in the month after discharge, 3 months after discharge, 6 months after discharge and 12 months after discharge.

Group Type: EXPERIMENTAL

Specific program functional and respiratory rehabilitation

Intervention Type: OTHER

It is a question of introducing a small program of physical activation pre-transplantation of hematopoietic progenitors, to continue developing it during the hospitalization and to use the functional measurements as a measure of its impact, as well as the different quality of life questionnaires.

control group

Patients' candidates for transplantation of hematopoietic progenitors prior to May 12, 2012, regardless of gender and age, who meet the inclusion criteria and are collected correlatively until completing 104 subjects.

Clinical history review to calculate the days of hospitalization in the different hospitalization units during the transplant. As well as the number and type of complications and the use of health resources. Status vitae. Baseline review of functional tests and exercise tolerance.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Specific program functional and respiratory rehabilitation

It is a question of introducing a small program of physical activation pre-transplantation of hematopoietic progenitors, to continue developing it during the hospitalization and to use the functional measurements as a measure of its impact, as well as the different quality of life questionnaires.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with malignant hemopathies candidates for HSCT.
• controlled pain.
• who sign informed consent.

Exclusion Criteria

• Severe musculoskeletal or neurological alterations prior to HSCT.
• Severe psychiatric problems.
• Language barrier.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Yolanda Torralba Garcia

Clinical investigator. BSN.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yolanda Torralba García, RN

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic de Barcelona. Fundació Clinic per a la Recerca Biomédica.

Locations

Hospital Clinic de Barcelona

Barcelona, , Spain

Countries

Spain

Other Identifiers

2012-7705

Identifier Type: -

Identifier Source: org_study_id