Physical Exercise for Hematopoietic Stem Cell Transplantation (HSCT)

Physical Activity Clinical Trial

— HSCT  

Official title:

Feasibility and Safety of a Novel Individualized In-hospital Exercise Training Program for Patients Undergoing Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03641729
• Other study ID #: 2,030,132
• Status: Completed
• Phase: N/A
• Start date: June 13, 2016
• Est. completion date: June 15, 2017

Study information

• Verified date: August 2018
• Source: Federal University of Juiz de Fora
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 15, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity

Intervention

Other:
• individualized exercise training program
The exercise training program was performed once daily, included 2- to 5-minute warm-up session (stretching, coordination and balance exercises), 10 to 20 minutes of moderate-intensity aerobic exercise using a cycle ergometer, 3 - to 5-sets 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. The aerobic training target zone was set at 50% to 70% of heart rate (HR) reserve.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Juiz de Fora

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recruitment rates	recruitment rates was considered as the acceptance rate of patients eligible for the intervention to participate in the exercise regime - goal 60%	up to 4 weeks
Primary	attrition rates	attrition rates was considered as the acceptance rate of patients eligible for the intervention to participate in the exercise regime - until 30%	up to 4 weeks
Primary	exercise adherence rates	exercise adherence rates was assessed as the total number of minutes the participants performed the aerobic exercise in relation to the planned exercise time of at least 70%.	up to 4 weeks
Primary	adverse events rates	Safety of the intervention was considered if the adverse events rates was less than 5%	up to 4 weeks
Secondary	Functional capacity	evaluated using the 6-minute step test (6ST)	up to 4 weeks
Secondary	Lower limb muscle strength	Lower limb muscle strength was assessed using the sit-to-stand test (STS)	up to 4 weeks
Secondary	Upper limb muscle strength	Upper limb muscle strength was assessed using a handgrip dynamometer (Sammons Preston Rolyan, 4 Sammons Court, Bolingbrook, IL 60440)	up to 4 weeks
Secondary	Health-related quality of life (HRQoL)	The European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire (EORTC QLQ-C30) was used to evaluate HRQoL. The questionnaire has three domains, including overall health, functional health and symptoms, with scores ranging from 0 to 100. Higher scores in the overall and functional health domains correspond to better quality of life, while higher scores on the symptoms scale correspond to worse quality of life.	up to 4 weeks

External Links

•   More information contact the principal investigator