Studying Changes in Physical Function Measures in Stem Cell Transplant Patients at Risk for Steroid Myopathy

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2021-03-18

Brief Summary

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This trial investigates the changes in physical and functional tests over time in patients with suspected acute graft versus host disease (from a hematologic stem cell transplant) who started treatment with corticosteroids. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Steroids are used to treat suspected graft-versus-host disease. Steroid myopathy (muscle weakness and fatigue) is a significant side effect of high dose steroid therapy, and can impair activities of daily of life. The goal of this trial is to learn how patients' physical activities and functions change over time while on GVHD-steroid treatment.

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Detailed Description

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PRIMARY OBJECTIVE:

I. To perform a pilot study to estimate the change in six physical and functional tests over time in patients with suspected acute graft-versus-host disease (GVHD) who have been initiated on treatment with corticosteroids.

SECONDARY OBJECTIVES:

I. To describe and potentially define steroid myopathy by following the patterns of the muscle loss and functional impairment in this population of patients.

II. To follow steroid myopathy and describe its incidence, its severity, and the impact on non-relapse mortality in a homogeneous population of patients with suspected acute graft-versus-host disease (GVHD) who have been initiated on treatment with corticosteroids at a quaternary institution in the inpatient and outpatient setting.

III. To estimate the adherence to an intermittently supervised exercise program in hematopoietic stem cell transplantation (HSCT) patients who are at risk of developing steroid myopathy.

OUTLINE:

Patients complete a physical function test over 15 minutes at baseline, and at days 14, 28, and 56. Patients also participate in an 8-week home-based strengthening and walking program consisting of a strengthening/resistance program for 30 minutes, 3 times a week, and walking program for 20-30 minutes at least 3 times a week.

Conditions

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Acute Graft Versus Host Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (exercise intervention)

Patients complete a physical function test over 15 minutes at baseline, and at days 14, 28, and 56. Patients also participate in an 8-week home-based strengthening and walking program consisting of a strengthening/resistance program for 30 minutes, 3 times a week, and walking program for 20-30 minutes at least 3 times a week.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Participate in an 8-week home-based strengthening and walking program

Physical Performance Testing

Intervention Type OTHER

Complete a physical function test

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Exercise Intervention

Participate in an 8-week home-based strengthening and walking program

Intervention Type BEHAVIORAL

Physical Performance Testing

Complete a physical function test

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Physical Fitness Testing Physical Function Testing

Eligibility Criteria

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Inclusion Criteria

* Participants are willing and able to give written informed consent and to comply with all of the study visits and procedures
* Age \>= 55 years, or with a Sorror co-morbidity index of \>= 3
* Post allogenic hematopoietic stem cell transplantation using bone marrow, peripheral blood or cord blood; or after pre planned donor lymphocyte infusion
* Presumptive diagnosis of acute GVHD necessitating high-dose corticosteroid treatment (with an approximate starting dose of methylprednisolone equivalent of 2 mg/kg/day)
* Within 5 days of receiving corticosteroid treatment
* ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2 or equivalent Karnofsky score of 60 or higher
* The patient is referred to the study by their stem cell transplant attending physician

Exclusion Criteria

* Non-English speaking
* Underlying unstable cardiac or pulmonary disease in the opinion of the investigator that limits participant involvement in exercise
* Has a pre-transplant echocardiogram with ejection fraction \< 45%
* Requires supplemental oxygen to maintain oxygen (O2) saturation \> 92%
* Musculoskeletal injury that precludes participation in an exercise program
* Inability to participate in a structured exercise program
* Patients for whom the physician feels is unsafe for an exercise program
* Platelets equal to or less than 10,000 or evidence of active bleeding
* Patients who are unable to understand or follow through with the exercise program

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No