Clinical trial NCT03886909: Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant
Official title: The Effects of a Prehabilitation Exercise Program in Adults Receiving a Hematopoietic Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplant
Hematologic Diseases
Physical Activity
Prehabilitation
Keywords: Exercise
Hematopoietic Stem Cell Transplant
Physical function
Quality of Life
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether patients are able to participate in a prehabilitation program (prior to the beginning of treatment) which includes: (1) a home-based exercise program or (2) just a prehabilitation education session.

Detailed description: Hematopoietic stem cell transplant may have the potential for severe side effects, including functional (reduced aerobic capacity, reduced muscle strength) and psychosocial (e.g. reduced quality of life, increased fatigue) detriments.

Evidence shows that exercise is considered to be an effective treatment approach in hematopoietic stem cell transplant patients during and after treatment with regard to the above mentioned side-effects. Also, prehabilitative exercise in colon and lung cancer patients was shown as feasible and effective. However, no experience exists with regard to prehabilitation exercise in hematopoietic stem cell transplant patients.

Eligibility criteria: Inclusion Criteria:

* Hematological cancer (e.g. Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Multiple Myeloma, Non-Hodgkin Lymphoma, etc.)
* Hematological cancer in remission
* Females and males ≥18 years of age
* Fluent in written and spoken English
* Must be able to provide and understand informed consent
* Must have an ECOG score of ≤ 2
* Scheduled for an inpatient autologous or allogeneic stem cell transplant at Penn State Cancer Institute
* ≥ 2 weeks until scheduled transplant
* Primary attending physician approval

Exclusion Criteria:

* Hematological cancer not in remission
* Evidence in the medical record of an absolute contraindication (e.g. Heart insufficiency \> NYHA III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability) for exercise
* Any other comorbidities or musculoskeletal complications that preclude participation in the exercise programs as deemed by the exercise interventionist
* Uncontrolled hypertension
* Receiving non-transplant related chemotherapy and/or radiotherapy
* Not fluent in written and spoken English
* Active infections, hemorrhages, and cytopenias that could place transplant patients at risk for further adverse events, deemed by the exercise interventionist, physician and/or nurse

Primary outcomes:
measure: Feasibility of the exercise intervention: 50% of included patients actually complete at least one third of the exercise sessions
timeFrame: Through study completion, an average of 18 months
measure: Acceptability of the exercise intervention: more than 50% of the patients approached
timeFrame: During recruitment
measure: Safety of the exercise intervention: questionnaire
timeFrame: Through the study completion, an average of 18 months
Secondary outcomes:
measure: Health-related Quality of Life: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0)
timeFrame: Through study completion, an average of 18 months
measure: Bone Marrow Transplant-related Quality of Life: EORTC QLQ-HDC29
timeFrame: Through study completion, an average of 18 months
measure: Fatigue
timeFrame: Through study completion, an average of 18 months
measure: Sleep
timeFrame: Through study completion, an average of 18 months
measure: Depression
timeFrame: Through study completion, an average of 18 months
measure: Short Questionnaire to Assess Health-Enhancing Physical Activity
timeFrame: Through study completion, an average of 18 months
measure: Godin Physical Activity Questionnaire
timeFrame: Through study completion, an average of 18 months
measure: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events
timeFrame: Through study completion, an average of 18 months
measure: Body Pain: Brief Pain Inventory- Short form
timeFrame: Through study completion, an average of 18 months
measure: Physical Function: Short Physical Performance Battery
timeFrame: Through study completion, an average of 18 months
measure: Aerobic Capacity: Six Minute Walk Test
timeFrame: Through study completion, an average of 18 months
measure: Physical Function: Timed-Up-and-Go Test
timeFrame: Through study completion, an average of 18 months
measure: Fall Risk
timeFrame: Through study completion, an average of 18 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine, Hershey
name: Kathryn Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: