Physical ActivityHSCTNCT03641729
Physical Exercise for Hematopoietic Stem Cell Transplantation (HSCT)
A study testing individualized exercise training program in people with Physical Activity, run by Federal University of Juiz de Fora.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity
- What is being tested?
- individualized exercise training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 13 Jun 2016to 15 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
About this study
Official title: Feasibility and Safety of a Novel Individualized In-hospital Exercise Training Program for Patients Undergoing Hematopoietic Stem Cell Transplantation
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.
Read more
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.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- individualized exercise training program
- Keywords
- hematopoietic stem cell transplantation, exercise training, feasibility, safety
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individualized exercise training programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: individualized exercise training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
recruitment rates
recruitment rates was considered as the acceptance rate of patients eligible for the intervention to participate in the exercise regime - goal 60%
Measured: 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%
Measured: 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%.
Measured: up to 4 weeks
adverse events rates
Safety of the intervention was considered if the adverse events rates was less than 5%
Measured: up to 4 weeks
Secondary outcomes (4)
Functional capacity
evaluated using the 6-minute step test (6ST)
Measured: up to 4 weeks
Lower limb muscle strength
Lower limb muscle strength was assessed using the sit-to-stand test (STS)
Measured: up to 4 weeks
Upper limb muscle strength
Upper limb muscle strength was assessed using a handgrip dynamometer (Sammons Preston Rolyan, 4 Sammons Court, Bolingbrook, IL 60440)
Measured: up to 4 weeks
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.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start13 Jun 2016
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline Priori Fioritto, Federal University of Juiz de Fora
- Investigators
- FIORITTO, Principal investigator, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641729
- Sponsor's protocol ID
- 2,030,132
- Acronym
- HSCT
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of a Novel Individualized In-hospital Exercise Training Program for Patients Undergoing Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03641729
- Acronym / sponsor ID
- HSCT / 2,030,132
- Conditions
- Physical Activity
- Keywords
- hematopoietic stem cell transplantation, exercise training, feasibility, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: individualized exercise training programPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individualized exercise training programThe 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. | Other | Intervention |
Primary outcome
recruitment rates
Time frame: up to 4 weeks
recruitment rates was considered as the acceptance rate of patients eligible for the intervention to participate in the exercise regime - goal 60%
attrition rates
Time frame: up to 4 weeks
attrition rates was considered as the acceptance rate of patients eligible for the intervention to participate in the exercise regime - until 30%
exercise adherence rates
Time frame: up to 4 weeks
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%.
adverse events rates
Time frame: up to 4 weeks
Safety of the intervention was considered if the adverse events rates was less than 5%
4 secondary outcomes
Functional capacity
Time frame: up to 4 weeks
Lower limb muscle strength
Time frame: up to 4 weeks
Upper limb muscle strength
Time frame: up to 4 weeks
Health-related quality of life (HRQoL)
Time frame: up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- More information contact the principal investigatorLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FIORITTO principal investigator
Federal University of Juiz de Fora
Questions about this trial
What is this clinical trial studying?
A study testing individualized exercise training program in people with Physical Activity, run by Federal University of Juiz de Fora.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recruitment rates (time frame: up to 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.