Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant (IMPROVE-BMT)

Penn State Health

Status: Completed

Conditions: Physical Activity; Hematopoietic Stem Cell Transplant; Prehabilitation; Hematologic Diseases

Treatments: Behavioral: Prehabilitation Education; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03886909

STUDY00010914

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Home-Based Prehabilitation

Active Comparator group

Description:

Will be offered an individual one-on-one appointment for an exercise introduction session with an exercise and cancer specialist and periodical phone calls to support and adapt the exercise program. The exercises should be done home-based for 5 times a week until the time of transplant.

Treatment:

Behavioral: Exercise

Prehabilitation Education

Active Comparator group

Description:

Will be offered a prehabilitation and stem cell education class at the Penn State Hershey Cancer Institute.

Treatment:

Behavioral: Prehabilitation Education