Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant

NCT ID: NCT03886909

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-28

Study Completion Date

2023-04-13

Brief Summary

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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

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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.

Conditions

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Hematopoietic Stem Cell Transplant Hematologic Diseases Physical Activity Prehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Home-Based Prehabilitation

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.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

The exercise intervention is at least 2 weeks lasting (till the day transplant is taking place) 5-times weekly resistance training intervention combined with aerobic exercise (mostly walking).

Prehabilitation Education

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

Group Type ACTIVE_COMPARATOR

Prehabilitation Education

Intervention Type BEHAVIORAL

Participant will receive a prehabilitation and stem cell education class which will be held at the Penn State Cancer Institute.

Interventions

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Exercise

The exercise intervention is at least 2 weeks lasting (till the day transplant is taking place) 5-times weekly resistance training intervention combined with aerobic exercise (mostly walking).

Intervention Type BEHAVIORAL

Prehabilitation Education

Participant will receive a prehabilitation and stem cell education class which will be held at the Penn State Cancer Institute.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Shin Mineishi

Professor, Public Health Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathryn Schmitz, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine, Hershey

Locations

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Penn State Cancer Institute

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

References

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Potiaumpai M, Schmitz KH, Mineishi S, Naik S, Wirk B, Rakszawski K, Ehmann WC, Claxton D, Nickolich M, Zemel BS, Zheng H. IMPROVE-BMT: a protocol for a pilot randomised controlled trial of prehabilitation exercise for adult haematopoietic stem cell transplant recipients. BMJ Open. 2023 Jan 18;13(1):e066841. doi: 10.1136/bmjopen-2022-066841.

Reference Type DERIVED
PMID: 36657760 (View on PubMed)

Other Identifiers

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STUDY00010914

Identifier Type: -

Identifier Source: org_study_id

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