Stem Cell TransplantationNCT06134297
Adherence, Viability, Clinical Evolution and Therapeutic Efficacy in Patients Undergoing Bone Marrow Transplantation
A study testing Cycle ergometer, Strength Training - elastic band and shin guards and Cycle ergometer, elastic band and shin guards in people with Stem Cell Transplantation, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
Hematological neoplasms originate from the differentiation and proliferation of abnormal lymphatic or myeloid cells that alter the constitution of elements of the blood, bone marrow and lymph nodes. Treatment includes high-dose chemotherapy alone or associated with hematopoietic stem cell transplantation (HSCT). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Stem Cell Transplantation
- What is being tested?
- Cycle ergometer, Strength Training - elastic band and shin guards and Cycle ergometer, elastic band and shin guards
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Mar 2022to Dec 2024
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be between 18 and 64 years old;
- Present hematological malignancy undergoing first antineoplastic treatment with HSCT;
- Have intact neurological function and cognition;
- Be in clinical conditions that allow participation in physical rehabilitation;
- To agree with the study proposal by signing the Free and Informed Consent Form (TCLE).
Who cannot join
- Present clinical complications that impair the performance of motor physiotherapy, including the practice of cycle ergometer and resistance exercises;
- Present previous musculoskeletal changes that interfere with the execution of physical performance assessment tests;
- Patients with limiting cardiovascular or pulmonary disease, significant psychiatric or neurological disorders and/or limiting interpretation of documents and forms that will be used in the study;
- Patients who require mobility assistance and/or diagnosed with multiple myeloma with or without the presence of bone metastasis;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
About this study
Official title: Adherence, Feasibility, Clinical Evolution Therapeutic Efficacy of Three Different Muscle Overload Models Used for Physical Rehabilitation of Patients Undergoing Bone Marrow Transplantation: a Randomized Clinical Trial
Hematological neoplasms originate from the differentiation and proliferation of abnormal lymphatic or myeloid cells that alter the constitution of elements of the blood, bone marrow and lymph nodes. Treatment includes high-dose chemotherapy alone or associated with hematopoietic stem cell transplantation (HSCT). However, the adverse effects of this treatment affect multiple organs and systems, reducing physical capacity, increasing the feeling of fatigue, anxiety and depression, which together affect quality of life. Patients who exercise before, during or after anti-neoplastic treatment demonstrate significant benefits. But rehabilitating physical capacity involves the challenge of fluctuations in the patient's readiness along with daily clinical variations, which ultimately directly affects the rate of adherence to exercises, impacting the effectiveness of the physical rehabilitation program. There is no specific individualization of muscular overload that takes into account such variability in pathophysiological, functional and psychological situations, but the cardiorespiratory response and muscular strength performance in the face of progressive overload can be measured with sufficient recovery periods to optimize the physiological adaptations promoted by muscular overload. regularly, even in patients undergoing antineoplastic treatment. Objective: To evaluate the adherence rate, operational feasibility, clinical/behavioral evolution and effectiveness of three different muscle overload models (aerobic, anaerobic and mixed) used for the physical rehabilitation of patients hospitalized for antineoplastic hematological treatment with HSCT
Read the detailed description
This is a randomized clinical trial. Patients will be allocated into groups (1) Aerobic; (2) Anaerobic and (3) Mixed. The manifestation of signs and symptoms will be evaluated using the Edmonton Symptom Assessment System (ESAS) inventory, a sensation of fatigue using the multidimensional fatigue questionnaire (MIF), and quality of life using the European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire. Questionnaire (EORTC QLQ-30) and the incidence and intensity of anxiety and depression symptoms using the General Hospital Anxiety and Depression Scale (HAD), in addition to the strength assessment of the upper limbs (HANDGRIP) and lower limbs (TSL). Participants in the aerobic group will perform exercises for the lower limbs with a cycle ergometer for 15 consecutive minutes and participants in the anaerobic group will perform exercises with an overload of shin weights or dumbbells of 0.5kg/1kg for large muscle groups. Participants in the mixed group will have a mixed muscular overload, performed by alternating between aerobic and anaerobic overload with a 1:1 ratio until the end of the program.
- Conditions
- Stem Cell Transplantation
- Being tested
- Cycle ergometer, Strength Training - elastic band and shin guards, Cycle ergometer, elastic band and shin guards
- Keywords
- Exercise Therapy, Fatigue, Hematologic Neoplasms
- Medical subject headings
- Fatigue, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycle ergometerDevice
The Aerobic Exercise Group will perform a cycle ergometer for 15 consecutive minutes with a load adjusted to maintain heart rate (HR) between 65-75% of the maximum HR predicted for age (HRmax = 200-age). Peripheral oxygen saturation will be controlled and, upon a sustained drop (> 2 minutes after load reduction) below 90%, the session will be interrupted. The subjective feeling of tiredness in the legs and shortness of breath will be constantly monitored and if values equal to or greater than 8 (0-10) occur, the exercise will be stopped.
Strength Training - elastic band and shin guardsDevice
The Anaerobic Exercise Group will perform muscular strength training using maximum strength, where the contraction time should not exceed 20 seconds. For the upper limbs, the overload used will be through the use of an elastic band, with guidance for the patient to perform the shoulder external rotation exercise, elbow flexion exercises and open row rowing exercise. For the lower limbs, bridge movements, lunges and sit-up exercises will be performed with a maximum of 15 repetitions, and overload with ankle weights or dumbbells can be used in addition to body weight. The muscle contraction should lead the patient to a state of muscular fatigue and if the objective is not achieved, the exercise will be adapted to require greater strength from the patient so that he or she can reach maximum strength.
Cycle ergometer, elastic band and shin guardsDevice
Mixed Exercise Group will perform the exercises by alternating between aerobic and anaerobic overload, in a 1:1 ratio until the end of the physical rehabilitation program, following exactly the same protocols described previously (alternating one session of the aerobic protocol and in the following session the anaerobic protocol).
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Group | Experimental | Aerobic exercise using a cycle ergometer lasting 15 consecutive minutes with load adjusted to maintain heart rate (HR) between 65-75% of the maximum HR predicted for age (HRmax = 200-age). Receives: Device: Cycle ergometer |
| Anaerobic Exercise Group | Experimental | Muscle strength training using shin guards and elastic bands to promote muscle overload, generating maximum force production, where the contraction time should not exceed 20 seconds. Receives: Device: Strength Training - elastic band and shin guards |
| Mixed Exercise Group | Experimental | Exercises through alternation between aerobic and anaerobic overload (performing the exercises from the previously mentioned groups on alternate days), in a 1:1 ratio until the end of the physical rehabilitation program. Receives: Device: Cycle ergometer, elastic band and shin guards |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the physical rehabilitation program for lower limb strength through sitting and standing exercises
It will be determined by evaluating lower limb strength performance in the 30-second sit-to-stand test. The score will be based on the number of repetitions performed during the 30 timed seconds.
Measured: During the period of hospital stay, an average 1 month.
Effectiveness of the physical rehabilitation program for upper limb strength using dynamometry
It will be determined by evaluating the strength performance of the upper limbs through dynamometry. The value will be given in kilograms of force. And it will be calculated through the average of three measurements.
Measured: During the period of hospital stay, an average 1 month
Adherence to physical rehabilitation sessions
It will be evaluated through the ratio between the number of sessions actually carried out by the number of days in which the minimum clinical conditions for practicing physical exercise can be fully characterized during the hospital admission.
Measured: During the period of hospital stay, an average 1 month
Operational viability for implementing the exercise protocol
It will be evaluated through the time needed to execute the different muscle overload protocols
Measured: During the period of hospital stay, an average 1 month
Satisfaction with physiotherapy care
It will be evaluated through a satisfaction questionnaire (contains 11 questions and a maximum score of 55 points; the higher the score, the better the test result and better satisfaction).
Measured: During the period of hospital stay, an average 1 month
Clinical behavioral evolution of signs and symptoms related to cancer
The following will be carried out at the beginning and end of the intervention:
- Edmonton Sympton Assessment System Inventory (scale with 9 items; each can be scored from 0 to 10; the final value of the scale is the sum of each item; the higher the score, the worse the symptoms).
Measured: During the period of hospital stay, an average 1 month
Clinical behavioral evolution of signs of fatigue
The following will be carried out at the beginning and end of the intervention:
- Multidimensional Fatigue Questionnaire - (20 questions scored from 1 to 5; the higher the final score, the worse the symptoms).
Measured: During the period of hospital stay, an average 1 month
Clinical behavioral evolution of signs of anxiety and depression
The following will be carried out at the beginning and end of the intervention:
- General Hospital Anxiety and Depression Scale (14 questions, scored from 0 to 3; the higher the final score, the worse the symptoms).
Measured: During the period of hospital stay, an average 1 month
Clinical behavioral evolution of quality of life perception
The following will be carried out at the beginning and end of the intervention:
- Basic Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer (30 questions scored from 1 to 4; the higher the final score, the worse the symptoms).
Measured: During the period of hospital stay, an average 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start7 Mar 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Stem Cell TransplantationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrício Edler Macagnan, Federal University of Health Science of Porto Alegre
- Investigators
- Fabricio E Macagnan, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134297
- Sponsor's protocol ID
- 54240221.5.0000.5335
- Status last verified
- Nov 2023
- First submitted
- 16 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wehrle A, Kneis S, Dickhuth HH, Gollhofer A, Bertz H. Endurance and resistance training in patients with acute leukemia undergoing induction chemotherapy-a randomized pilot study. Support Care Cancer. 2019 Mar;27(3):1071-1079. doi: 10.1007/s00520-018-4396-6. Epub 2018 Aug 18.
PubMed 30121789van Haren IE, Timmerman H, Potting CM, Blijlevens NM, Staal JB, Nijhuis-van der Sanden MW. Physical exercise for patients undergoing hematopoietic stem cell transplantation: systematic review and meta-analyses of randomized controlled trials. Phys Ther. 2013 Apr;93(4):514-28. doi: 10.2522/ptj.20120181. Epub 2012 Dec 6.
PubMed 23224217Tran J, Norder EE, Diaz PT, Phillips GS, Elder P, Devine SM, Wood KL. Pulmonary rehabilitation for bronchiolitis obliterans syndrome after hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2012 Aug;18(8):1250-4. doi: 10.1016/j.bbmt.2012.01.017. Epub 2012 Jan 30.
PubMed 22300617THOMAS ED, LOCHTE HL Jr, CANNON JH, SAHLER OD, FERREBEE JW. Supralethal whole body irradiation and isologous marrow transplantation in man. J Clin Invest. 1959 Oct;38(10 Pt 1-2):1709-16. doi: 10.1172/JCI103949. No abstract available.
PubMed 13837954Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Steinberg A, Asher A, Bailey C, Fu JB. The role of physical rehabilitation in stem cell transplantation patients. Support Care Cancer. 2015 Aug;23(8):2447-60. doi: 10.1007/s00520-015-2744-3. Epub 2015 May 14.
PubMed 25971213Storb R, Sandmaier BM. Nonmyeloablative allogeneic hematopoietic cell transplantation. Haematologica. 2016 May;101(5):521-30. doi: 10.3324/haematol.2015.132860.
PubMed 27132278de Souza CV, Miranda EC, Garcia C Jr, Aranha FJ, de Souza CA, Vigorito AC. Functional evaluation indicates physical losses after hematopoietic stem cell transplantation. Rev Bras Hematol Hemoter. 2012;34(5):345-51. doi: 10.5581/1516-8484.20120090.
PubMed 23125542Shechtman O, Sindhu BS, Davenport PW. Using the force-time curve to detect maximal grip strength effort. J Hand Ther. 2007 Jan-Mar;20(1):37-47; quiz 48. doi: 10.1197/j.jht.2006.10.006.
PubMed 17254907Schuler MK, Hornemann B, Pawandenat C, Kramer M, Hentschel L, Beck H, Kasten P, Singer S, Schaich M, Ehninger G, Platzbecker U, Schetelig J, Bornhauser M. Feasibility of an exercise programme in elderly patients undergoing allogeneic stem cell transplantation - a pilot study. Eur J Cancer Care (Engl). 2016 Sep;25(5):839-48. doi: 10.1111/ecc.12400. Epub 2015 Nov 3.
PubMed 26526286Sasso JP, Eves ND, Christensen JF, Koelwyn GJ, Scott J, Jones LW. A framework for prescription in exercise-oncology research. J Cachexia Sarcopenia Muscle. 2015 Jun;6(2):115-24. doi: 10.1002/jcsm.12042. Epub 2015 May 11.
PubMed 26136187Ries AL, Make BJ, Lee SM, Krasna MJ, Bartels M, Crouch R, Fishman AP; National Emphysema Treatment Trial Research Group. The effects of pulmonary rehabilitation in the national emphysema treatment trial. Chest. 2005 Dec;128(6):3799-809. doi: 10.1378/chest.128.6.3799.
PubMed 16354848van Dongen JM, Persoon S, Jongeneel G, Bosmans JE, Kersten MJ, Brug J, Nollet F, Chinapaw MJM, Buffart LM. Long-term effectiveness and cost-effectiveness of an 18-week supervised exercise program in patients treated with autologous stem cell transplantation: results from the EXIST study. J Cancer Surviv. 2019 Aug;13(4):558-569. doi: 10.1007/s11764-019-00775-9. Epub 2019 Jul 8.
PubMed 31286387Persoon S, Kersten MJ, van der Weiden K, Buffart LM, Nollet F, Brug J, Chinapaw MJ. Effects of exercise in patients treated with stem cell transplantation for a hematologic malignancy: a systematic review and meta-analysis. Cancer Treat Rev. 2013 Oct;39(6):682-90. doi: 10.1016/j.ctrv.2013.01.001. Epub 2013 Feb 26.
PubMed 23485478Paul KL. Rehabilitation and exercise considerations in hematologic malignancies. Am J Phys Med Rehabil. 2011 May;90(5 Suppl 1):S88-94. doi: 10.1097/PHM.0b013e31820be055.
PubMed 21765268
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence, Feasibility, Clinical Evolution Therapeutic Efficacy of Three Different Muscle Overload Models Used for Physical Rehabilitation of Patients Undergoing Bone Marrow Transplantation: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06134297
- Acronym / sponsor ID
- 54240221.5.0000.5335
- Conditions
- Stem Cell Transplantation
- Keywords
- Exercise Therapy, Fatigue, Hematologic Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Nov 2023 (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.
Hematological neoplasms originate from the differentiation and proliferation of abnormal lymphatic or myeloid cells that alter the constitution of elements of the blood, bone marrow and lymph nodes. Treatment includes high-dose chemotherapy alone or associated with hematopoietic stem cell transplantation (HSCT). However, the adverse effects of this treatment affect multiple organs and systems, reducing physical capacity, increasing the feeling of fatigue, anxiety and depression, which together affect quality of life. Patients who exercise before, during or after anti-neoplastic treatment demonstrate significant benefits. But rehabilitating physical capacity involves the challenge of fluctuations in the patient's readiness along with daily clinical variations, which ultimately directly affects the rate of adherence to exercises, impacting the effectiveness of the physical rehabilitation program. There is no specific individualization of muscular overload that takes into account such variability in pathophysiological, functional and psychological situations, but the cardiorespiratory response and muscular strength performance in the face of progressive overload can be measured with sufficient recovery periods to optimize the physiological adaptations promoted by muscular overload. regularly, even in patients undergoing antineoplastic treatment. Objective: To evaluate the adherence rate, operational feasibility, clinical/behavioral evolution and effectiveness of three different muscle overload models (aerobic, anaerobic and mixed) used for the physical rehabilitation of patients hospitalized for antineoplastic hematological treatment with HSCT
Detailed description
This is a randomized clinical trial. Patients will be allocated into groups (1) Aerobic; (2) Anaerobic and (3) Mixed. The manifestation of signs and symptoms will be evaluated using the Edmonton Symptom Assessment System (ESAS) inventory, a sensation of fatigue using the multidimensional fatigue questionnaire (MIF), and quality of life using the European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire. Questionnaire (EORTC QLQ-30) and the incidence and intensity of anxiety and depression symptoms using the General Hospital Anxiety and Depression Scale (HAD), in addition to the strength assessment of the upper limbs (HANDGRIP) and lower limbs (TSL). Participants in the aerobic group will perform exercises for the lower limbs with a cycle ergometer for 15 consecutive minutes and participants in the anaerobic group will perform exercises with an overload of shin weights or dumbbells of 0.5kg/1kg for large muscle groups. Participants in the mixed group will have a mixed muscular overload, performed by alternating between aerobic and anaerobic overload with a 1:1 ratio until the end of the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Group | Experimental | Device: Cycle ergometerAerobic exercise using a cycle ergometer lasting 15 consecutive minutes with load adjusted to maintain heart rate (HR) between 65-75% of the maximum HR predicted for age (HRmax = 200-age). |
| Anaerobic Exercise Group | Experimental | Device: Strength Training - elastic band and shin guardsMuscle strength training using shin guards and elastic bands to promote muscle overload, generating maximum force production, where the contraction time should not exceed 20 seconds. |
| Mixed Exercise Group | Experimental | Device: Cycle ergometer, elastic band and shin guardsExercises through alternation between aerobic and anaerobic overload (performing the exercises from the previously mentioned groups on alternate days), in a 1:1 ratio until the end of the physical rehabilitation program. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be between 18 and 64 years old;
- Present hematological malignancy undergoing first antineoplastic treatment with HSCT;
- Have intact neurological function and cognition;
- Be in clinical conditions that allow participation in physical rehabilitation;
- To agree with the study proposal by signing the Free and Informed Consent Form (TCLE).
Key exclusion criteria (4 listed)
- Present clinical complications that impair the performance of motor physiotherapy, including the practice of cycle ergometer and resistance exercises;
- Present previous musculoskeletal changes that interfere with the execution of physical performance assessment tests;
- Patients with limiting cardiovascular or pulmonary disease, significant psychiatric or neurological disorders and/or limiting interpretation of documents and forms that will be used in the study;
- Patients who require mobility assistance and/or diagnosed with multiple myeloma with or without the presence of bone metastasis;
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 |
|---|---|---|
| Cycle ergometerThe Aerobic Exercise Group will perform a cycle ergometer for 15 consecutive minutes with a load adjusted to maintain heart rate (HR) between 65-75% of the maximum HR predicted for age (HRmax = 200-age). Peripheral oxygen saturation will be controlled and, upon a sustained drop (> 2 minutes after load reduction) below 90%, the session will be interrupted. The subjective feeling of tiredness in the legs and shortness of breath will be constantly monitored and if values equal to or greater than 8 (0-10) occur, the exercise will be stopped. | Device | Aerobic Exercise Group |
| Strength Training - elastic band and shin guardsThe Anaerobic Exercise Group will perform muscular strength training using maximum strength, where the contraction time should not exceed 20 seconds. For the upper limbs, the overload used will be through the use of an elastic band, with guidance for the patient to perform the shoulder external rotation exercise, elbow flexion exercises and open row rowing exercise. For the lower limbs, bridge movements, lunges and sit-up exercises will be performed with a maximum of 15 repetitions, and overload with ankle weights or dumbbells can be used in addition to body weight. The muscle contraction should lead the patient to a state of muscular fatigue and if the objective is not achieved, the exercise will be adapted to require greater strength from the patient so that he or she can reach maximum strength. | Device | Anaerobic Exercise Group |
| Cycle ergometer, elastic band and shin guardsMixed Exercise Group will perform the exercises by alternating between aerobic and anaerobic overload, in a 1:1 ratio until the end of the physical rehabilitation program, following exactly the same protocols described previously (alternating one session of the aerobic protocol and in the following session the anaerobic protocol). | Device | Mixed Exercise Group |
Primary outcome
Effectiveness of the physical rehabilitation program for lower limb strength through sitting and standing exercises
Time frame: During the period of hospital stay, an average 1 month.
It will be determined by evaluating lower limb strength performance in the 30-second sit-to-stand test. The score will be based on the number of repetitions performed during the 30 timed seconds.
Effectiveness of the physical rehabilitation program for upper limb strength using dynamometry
Time frame: During the period of hospital stay, an average 1 month
It will be determined by evaluating the strength performance of the upper limbs through dynamometry. The value will be given in kilograms of force. And it will be calculated through the average of three measurements.
Adherence to physical rehabilitation sessions
Time frame: During the period of hospital stay, an average 1 month
It will be evaluated through the ratio between the number of sessions actually carried out by the number of days in which the minimum clinical conditions for practicing physical exercise can be fully characterized during the hospital admission.
Operational viability for implementing the exercise protocol
Time frame: During the period of hospital stay, an average 1 month
It will be evaluated through the time needed to execute the different muscle overload protocols
Satisfaction with physiotherapy care
Time frame: During the period of hospital stay, an average 1 month
It will be evaluated through a satisfaction questionnaire (contains 11 questions and a maximum score of 55 points; the higher the score, the better the test result and better satisfaction).
Clinical behavioral evolution of signs and symptoms related to cancer
Time frame: During the period of hospital stay, an average 1 month
The following will be carried out at the beginning and end of the intervention: - Edmonton Sympton Assessment System Inventory (scale with 9 items; each can be scored from 0 to 10; the final value of the scale is the sum of each item; the higher the score, the worse the symptoms).
Clinical behavioral evolution of signs of fatigue
Time frame: During the period of hospital stay, an average 1 month
The following will be carried out at the beginning and end of the intervention: - Multidimensional Fatigue Questionnaire - (20 questions scored from 1 to 5; the higher the final score, the worse the symptoms).
Clinical behavioral evolution of signs of anxiety and depression
Time frame: During the period of hospital stay, an average 1 month
The following will be carried out at the beginning and end of the intervention: - General Hospital Anxiety and Depression Scale (14 questions, scored from 0 to 3; the higher the final score, the worse the symptoms).
Clinical behavioral evolution of quality of life perception
Time frame: During the period of hospital stay, an average 1 month
The following will be carried out at the beginning and end of the intervention: - Basic Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer (30 questions scored from 1 to 4; the higher the final score, the worse the symptoms).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 30121789Wehrle A, Kneis S, Dickhuth HH, Gollhofer A, Bertz H. Endurance and resistance training in patients with acute leukemia undergoing induction chemotherapy-a randomized pilot study. Support Care Cancer. 2019 Mar;27(3):1071-1079. doi: 10.1007/s00520-018-4396-6. Epub 2018 Aug 18.
- Background: PubMed 23224217van Haren IE, Timmerman H, Potting CM, Blijlevens NM, Staal JB, Nijhuis-van der Sanden MW. Physical exercise for patients undergoing hematopoietic stem cell transplantation: systematic review and meta-analyses of randomized controlled trials. Phys Ther. 2013 Apr;93(4):514-28. doi: 10.2522/ptj.20120181. Epub 2012 Dec 6.
- Background: PubMed 22300617Tran J, Norder EE, Diaz PT, Phillips GS, Elder P, Devine SM, Wood KL. Pulmonary rehabilitation for bronchiolitis obliterans syndrome after hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2012 Aug;18(8):1250-4. doi: 10.1016/j.bbmt.2012.01.017. Epub 2012 Jan 30.
- Background: PubMed 13837954THOMAS ED, LOCHTE HL Jr, CANNON JH, SAHLER OD, FERREBEE JW. Supralethal whole body irradiation and isologous marrow transplantation in man. J Clin Invest. 1959 Oct;38(10 Pt 1-2):1709-16. doi: 10.1172/JCI103949. No abstract available.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 25971213Steinberg A, Asher A, Bailey C, Fu JB. The role of physical rehabilitation in stem cell transplantation patients. Support Care Cancer. 2015 Aug;23(8):2447-60. doi: 10.1007/s00520-015-2744-3. Epub 2015 May 14.
- Background: PubMed 27132278Storb R, Sandmaier BM. Nonmyeloablative allogeneic hematopoietic cell transplantation. Haematologica. 2016 May;101(5):521-30. doi: 10.3324/haematol.2015.132860.
- Background: PubMed 23125542de Souza CV, Miranda EC, Garcia C Jr, Aranha FJ, de Souza CA, Vigorito AC. Functional evaluation indicates physical losses after hematopoietic stem cell transplantation. Rev Bras Hematol Hemoter. 2012;34(5):345-51. doi: 10.5581/1516-8484.20120090.
- Background: PubMed 17254907Shechtman O, Sindhu BS, Davenport PW. Using the force-time curve to detect maximal grip strength effort. J Hand Ther. 2007 Jan-Mar;20(1):37-47; quiz 48. doi: 10.1197/j.jht.2006.10.006.
- Background: PubMed 26526286Schuler MK, Hornemann B, Pawandenat C, Kramer M, Hentschel L, Beck H, Kasten P, Singer S, Schaich M, Ehninger G, Platzbecker U, Schetelig J, Bornhauser M. Feasibility of an exercise programme in elderly patients undergoing allogeneic stem cell transplantation - a pilot study. Eur J Cancer Care (Engl). 2016 Sep;25(5):839-48. doi: 10.1111/ecc.12400. Epub 2015 Nov 3.
- Background: PubMed 26136187Sasso JP, Eves ND, Christensen JF, Koelwyn GJ, Scott J, Jones LW. A framework for prescription in exercise-oncology research. J Cachexia Sarcopenia Muscle. 2015 Jun;6(2):115-24. doi: 10.1002/jcsm.12042. Epub 2015 May 11.
- Background: PubMed 16354848Ries AL, Make BJ, Lee SM, Krasna MJ, Bartels M, Crouch R, Fishman AP; National Emphysema Treatment Trial Research Group. The effects of pulmonary rehabilitation in the national emphysema treatment trial. Chest. 2005 Dec;128(6):3799-809. doi: 10.1378/chest.128.6.3799.
- Individual participant dataSharing planned: No
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Mucopolysaccharidosis Disorders, Hurler Syndrome
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
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.
Fabricio E Macagnan principal investigator
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycle ergometer, Strength Training - elastic band and shin guards and Cycle ergometer, elastic band and shin guards in people with Stem Cell Transplantation, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Effectiveness of the physical rehabilitation program for lower limb strength through sitting and standing exercises (time frame: During the period of hospital stay, an average 1 month.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06134297, which also lists 42 linked publications.
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 18 Nov 2023.