Effectiveness Rehabilitation Hematopoietic Transplantation (ovERsHOT)

NCT03324620 | Completed

• 1 other identifier: 2012-7705
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Cost of interventions assesed by the cost of hospitalization for HSCT

  For the calculation the days of hospitalization in each hospitalization unit care are counted. Then, the total number of days spent in each unit (D): (intensive care unit, ICU (A), isolation chamber (B), single room (C). The cost of hospitalization for HSCT: (a: price / day in the ICU, b: price / day in isolation chamber, c: price / day in single room, in euros). Dd = (Aa) + (Bb) + (Cc), in euros.

  Admission

• Cost of interventions assesed by the cost incorporation of a physiotherapist into the team

  To calculate the cost, a physiotherapist will be hired 4 hours / day for the intervention group. Day of hospitalization for the transplant (D) multiplied by the cost per day of the physiotherapist (euros).

  Admission

• Cost of interventions assesed by the number (number), characteristics and incidence of the immediate complications of HSCT

  Incidence expressed as a percentage. Comparison between the two groups (total number and percentage)

  Admisssion

• Cost of interventions assesed by antimicrobials used in infectious complications and chemotherapy conditioning.

  expressed in euros

  Admission

Secondary Outcomes (12)

• Adherence to the program and evaluation of the knowledge acquired by the patient.

  Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.

• Referred quality of life: quality of life as assessed by the FACT (Functional Assessment of Cancer Therapy) leukemia questionnaire (Scale info can be included in the description.)

  Admission.

• Referred quality of life: quality of life as assessed by the FACT (Functional Assessment of Cancer Therapy) lymfhoma questionnaire (Scale info can be included in the description.)

  Admission.

• Referred quality of life: quality of life as assessed by the FACT (Functional Assessment of Cancer Therapy) multiple myeloma questionnaire (Scale info can be included in the description.)

  Admission.

• Referred quality of life: quality of life as assessed by the FACT (Functional Assessment of Cancer Therapy) Bone marrow transplant (Scale info can be included in the description.)

  Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.

Study Arms (2)

pre active HSCT

EXPERIMENTAL

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.

Other: Specific program functional and respiratory rehabilitation

control group

NO INTERVENTION

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.

Interventions

Specific program functional and respiratory rehabilitation 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.

pre active HSCT

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Yolanda Torralba García, RN

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 86 patients in experimental group. 104 patients retrospectively collected from the inclusion of the first patient of the intervention group.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical investigator. BSN.

Model Details: Mixed study. Retrospective control group.

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: October 27, 2017
• Study Start: May 12, 2012
• Primary Completion: May 12, 2012
• Study Completion: September 15, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)