Clinical trial NCT03641729: Physical Exercise for Hematopoietic Stem Cell Transplantation (HSCT)
Official title: Feasibility and Safety of a Novel Individualized In-hospital Exercise Training Program for Patients Undergoing Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: hematopoietic stem cell transplantation
exercise training
feasibility
safety
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The exercise training program was performed once daily during the hospital stay. The program included 2- to 5-minute warm-up session which consisted of stretching, coordination and balance exercises, followed by 10 to 20 minutes of moderate-intensity aerobic exercise using a lower limb cycle ergometer (Live up Sports, 1023, Araucária, Paraná, LS9055). Participants also performed three sets of five to ten repetitions of sit-to-stand exercises with a 1-minute rest interval between each set. A cool-down period of 2- to 5-minutes of stretching and breathing exercises was delivered at the end of the exercise session. All exercises were performed within the participant's room. The aerobic training target zone was set at 50% to 70% of heart rate (HR) reserve. The HR reserve was estimated using the following equation: \[(220-age in years) - resting HR\] x \[50 to 70%\] + resting HR.
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate whether a novel individualized exercise training program for hospitalized patients undergoing hematopoietic stem cell transplantation (HSCT) is feasible and safe and whether it would improve functional capacity, muscle strength and health-related quality of life (HRQoL).

Design: Prospective, within-group, feasibility intervention study. Setting: Bone marrow transplant unit in a general hospital. Subjects: Patients electively hospitalized for HSCT who were admitted to the bone marrow transplant unit.

Intervention: Participants performed the individualized in-hospital exercise training program on a daily basis during their hospital admission. The exercise training program was performed once a day for 20 to 40 minutes and included a warm-up period, moderate-intensity aerobic exercise (10 to 20 minutes ), muscle strengthening exercise and cool-down activities.

Outcome measures: The primary outcomes were feasibility (consent rate, attrition rate and exercise adherence) and the safety of the exercise program. Secondary outcomes included functional capacity (step test), peripheral muscle strength (sit-to-stand test) and HRQoL (QLQ-C30) were evaluated at baseline (on admission to hospital) and prior to hospital discharge.

Detailed description: This was a prospective, within-group, feasibility intervention study which took place at the Juiz de Fora University Hospital (HU-JF) between June 2016 and June 2017.

Patients were screened in the Bone Marrow Transplant Unit (BMTU) admission and recruited to the study after avaliation in the first-day internation. However, included at study or no, all patients that had the indication (at any time during internation) received the intervention. This study was approved by the Institutional Ethics Committee (protocol: 2,030,132). All participants provided written informed consent prior to participation.

The exercise training program was performed once daily during the hospital stay. The program included 2- to 5-minute warm-up session which consisted of stretching, coordination and balance exercises, followed by 10 to 20 minutes of moderate-intensity aerobic exercise using a lower limb cycle ergometer (Live up Sports, 1023, Araucária, Paraná, LS9055). Participants also performed three sets of five to ten repetitions of sit-to-stand exercises with a 1-minute rest interval between each set. A cool-down period of 2- to 5-minutes of stretching and breathing exercises was delivered at the end of the exercise session. All exercises were performed within the participant's room. The aerobic training target zone was set at 50% to 70% of heart rate (HR) reserve. The HR reserve was estimated using the following equation: \[(220-age in years) - resting HR\] x \[50 to 70%\] + resting HR.

The indication, contraindication or interruption criteria of the exercise training program were evaluated daily based on the participant's clinical, hemodynamic and hematological parameters as described in Table 1. These parameters were recorded at rest and monitored during the intervention. The daily clinical assessment for exercise performance is described in the flowchart shown in Figure 1. A platelet count of \< 10,000 cells/mm3 (cells per cubic millimeter), hemoglobin (Hb) \< 7 g/dL (grams per deciliter) and/or hematocrit (Ht) \< 20% were considered contraindications for the exercise program. If participants were clinically stable, they were encouraged to perform breathing exercises in bed; maintain Basic Activity of Daily Living (BADLs), which consist mostly of self-care tasks including showering, dressing and feeding; perform the individualized in-hospital exercise training program, including a moderate intensity aerobic training without or with cycle ergometer load, based on platelets, hematocrit and hemoglobin count.

Eligibility criteria: Inclusion Criteria:

* Patients were eligible for this study if they were aged 18 years or older
* And referred for HSCT and admitted to the Bone Marrow Transplant Unit (BMTU).

Exclusion Criteria:

* Patients were excluded if they were re-admitted to the hospital due to post-HSCT complications (infection, respiratory/cardiovascular complications, graft-versus-host disease - GVHD)
* Or diagnosed with any orthopedic and/or cognitive limitations that constrained the study assessments and/or training participation

Primary outcomes:
measure: recruitment rates
timeFrame: up to 4 weeks
measure: attrition rates
timeFrame: up to 4 weeks
measure: exercise adherence rates
timeFrame: up to 4 weeks
measure: adverse events rates
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Functional capacity
timeFrame: up to 4 weeks
measure: Lower limb muscle strength
timeFrame: up to 4 weeks
measure: Upper limb muscle strength
timeFrame: up to 4 weeks
measure: Health-related quality of life (HRQoL)
timeFrame: up to 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Juiz de Fora
name: FIORITTO
role: PRINCIPAL_INVESTIGATOR
References: