Physical Impairments in Allogeneic-HSCT

Stem Cell Transplantation Clinical Trial

Official title:

Physiological Responses to Maximal Exercise Capacity and Muscle Strength in Survived Hematopoietic Stem Cell Transplantation Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448627
• Other study ID #: GaziUniversity6
• Status: Completed
• Start date: March 2012
• Est. completion date: December 2017

Study information

• Verified date: April 2019
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pulmonary functions, exercise capacity and muscle strength deteriorate in survived hematopoietic stem cell transplantation (HSCT) recipients due to toxic effects of chemotherapy, radiotherapy, conditioning regimens and/or corticosteroid use before HSCT, prolonged stay of recipients in rooms with laminar airflow and strict infection control rules during process of HSCT. There are also limited numbers of studies demonstrated pulmonary function abnormalities, decreased maximal exercise capacity, respiratory and peripheral muscle weakness in recipients. Current study was planned since no study compared pulmonary functions, maximal exercise capacity, respiratory and peripheral muscle strength between recipients and healthy individuals in the literature.

Description:

Treatments of hematologic malignancies consist of chemotherapy, radiotherapy, surgery, medical treatment, supportive care and/or hematopoietic stem cell transplantation (HSCT) which is resulted in early or late adverse effects on body systems, tissues and organs. Physical deconditioning is also observed in patients with hematologic malignancies because of reasons such as neurotoxic and pulmonary toxic effects of long term these anticancer treatments, immobilization, recommendation of resting and avoiding intense exercise, nutrition problems, severe anemia and thrombocytopenia etc. For these reasons, normal physical activities may not be kept on by patients which induces decreased physical performance.

The HSCT provides longer survival with standard treatments for patients with hematological malignancies while it increases risk of HSCT-related toxicity, complications and even mortality. Infectious and non-infectious pulmonary complications occur in about 60% of HSCT recipients and intensive-care unit support is also required in one-third of recipients for these reasons. Restrictive lung disease prior to allogeneic HSCT is related to early respiratory failure, non-relapse mortality and respiratory muscle weakness in post transplantation period. Therefore pulmonary restriction is considered as a risk factor for complications or failure of HSCT. Moreover it is known that carbon monoxide diffusing capacity of lungs which is the most common abnormality seen in pulmonary function test, respiratory muscle strength and functional exercise capacity are reduced in the majority of patients before HSCT. In addition to muscle weakness and decreased exercise capacity at prior to HSCT, patients experience more reduction in both inspiratory and expiratory muscles and exercise capacity after HSCT. Unfortunately, exercise capacity and peripheral muscle strength are decreased in HSCT recipients in spite of doing regular and planned exercise during acute process of HSCT. The average reduction in functional exercise capacity of recipients is 48 m. As shown in the literature, limited number of study has used evaluation of maximal exercise capacity with Modified-Incremental Shuttle Walk Test (ISWT) in HSCT patients and recipients. On the other hand, it has been reported that ISWT is a reliable test and has no adverse event or side effects for HSCT recipients in these studies, as well. Despite the fact that there is no negative feedback related to using of this test in recipients, no study comprehensively demonstrated influence of HSCT on maximal exercise capacity.

Impairments in pulmonary functions, respiratory muscle strength and maximal exercise capacity have been demonstrated in limited number of studies. Moreover, there is no study compared pulmonary functions, respiratory muscle strength and maximal exercise capacity between HSCT recipients and healthy individuals. Therefore investigators aimed to compare aforementioned outcomes between recipients and healthy individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 2017
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria for recipients:

• between ages of 18 and 70

• under standard medical treatment

• underwent allogeneic HSCT who were at minimum 100 days status post-transplantation

Exclusion Criteria for recipients:

• having cognitive disorder, orthopedic or neurological disease with a potential to affect assessment of maximal exercise capacity,

• having comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute respiratory or other infections,

• having problems like visual and mucositis which may prevent measurements,

• acute hemorrhage anywhere in the body,

• hemoglobin value less than 8 g/L and platelet count less than 10.000 mm3

Inclusion Criteria for healthy individuals:

• being individuals without known and diagnosed any chronic diseases

• not actively smoking

• their cigarette exposure is not greater than 5 pack*year.

Related Conditions & MeSH terms

• Stem Cell Transplantation

Locations

Country	Name	City	State
Turkey	Gazi University Faculty of Health Science Department of PhysioTherapy	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Bargi G, Güçlü MB, Aribas Z, Aki SZ, Sucak GT. Inspiratory muscle training in allogeneic hematopoietic stem cell transplantation recipients: a randomized controlled trial. Support Care Cancer. 2016 Feb;24(2):647-659. doi: 10.1007/s00520-015-2825-3. Epub 2 — View Citation

Bird L, Arthur A, Niblock T, Stone R, Watson L, Cox K. Rehabilitation programme after stem cell transplantation: randomized controlled trial. J Adv Nurs. 2010 Mar;66(3):607-15. doi: 10.1111/j.1365-2648.2009.05232.x. — View Citation

Knols RH, de Bruin ED, Uebelhart D, Aufdemkampe G, Schanz U, Stenner-Liewen F, Hitz F, Taverna C, Aaronson NK. Effects of an outpatient physical exercise program on hematopoietic stem-cell transplantation recipients: a randomized clinical trial. Bone Marr — View Citation

Kovalszki A, Schumaker GL, Klein A, Terrin N, White AC. Reduced respiratory and skeletal muscle strength in survivors of sibling or unrelated donor hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Jun;41(11):965-9. doi: 10.1038/bmt.20 — View Citation

Morishita S, Kaida K, Yamauchi S, Sota K, Ishii S, Ikegame K, Kodama N, Ogawa H, Domen K. Relationship between corticosteroid dose and declines in physical function among allogeneic hematopoietic stem cell transplantation patients. Support Care Cancer. 20 — View Citation

Morishita S, Kaida K, Yamauchi S, Wakasugi T, Ikegame K, Ogawa H, Domen K. Relationship of physical activity with physical function and health-related quality of life in patients having undergone allogeneic haematopoietic stem-cell transplantation. Eur J — View Citation

Shelton ML, Lee JQ, Morris GS, Massey PR, Kendall DG, Munsell MF, Anderson KO, Simmonds MJ, Giralt SA. A randomized control trial of a supervised versus a self-directed exercise program for allogeneic stem cell transplant patients. Psychooncology. 2009 Ap — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified-Incremental Shuttle Walk Test (ISWT)	This test was used to evaluate maximal exercise capacity	15-20 minutes
Secondary	pulmonary function test	This test was evaluated using a spirometry	5 minutes
Secondary	inspiratory and expiratory muscle strength (MIP, MEP)	Respiratory muscle strength was evaluated with a mouth pressure device	5-10 minutes
Secondary	Quadriceps femoris muscle strength	Peripheral muscle strength was evaluated with a hand-held dynamometer	5 minutes