Effectiveness Rehabilitation Hematopoietic Transplantation (ovERsHOT)
Condition: Hematopoietic Stem Cell Transplantation
Study type: Interventional

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.
    

Intervention name(s): Specific program functional and respiratory rehabilitation
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Mixed study. Retrospective control group.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: physiotherapy; nurse; Cost effectiveness; Activities of Daily Living; exercise tolerance; Allogeneic; Quality of Life; Rehabilitation; Physical Activity