Physical Exercise for Hematopoietic Stem Cell Transplantation (HSCT)

NCT03641729 | Completed

• 1 other identifier: 2,030,132
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Physical Activity

Keywords

hematopoietic stem cell transplantation; exercise training; feasibility; safety

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• adverse events rates

  Safety of the intervention was considered if the adverse events rates was less than 5%

  up to 4 weeks

Secondary Outcomes (4)

• Functional capacity

  up to 4 weeks

• Lower limb muscle strength

  up to 4 weeks

• Upper limb muscle strength

  up to 4 weeks

• Health-related quality of life (HRQoL)

  up to 4 weeks

Study Arms (1)

Intervention

OTHER

Patients were eligible if they were aged 18 years or older, referred for HSCT and admitted to the Bone Marrow Transplant Unit (BMTU). Patients were screened in the BMTU admission and recruited to the study after avaliation in the first-day internation.

Other: individualized exercise training program

Interventions

individualized exercise training program OTHER

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.

Intervention

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Juiz de Fora: lead

Related Links

• More information contact the principal investigator

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• FIORITTO

  Federal University of Juiz de Fora

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator/ Post-Graduation Program on Collective Health

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 22, 2018
• Study Start: June 13, 2016
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2017
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share