Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant

NCT03886909 | Completed

• 1 other identifier: STUDY00010914
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Exercise; Hematopoietic Stem Cell Transplant; Physical function; Quality of Life

Outcome Measures

Primary Outcomes (3)

• Feasibility of the exercise intervention: 50% of included patients actually complete at least one third of the exercise sessions

  The exercise intervention will be considered feasible if 50% of included patients actually complete at least one third of the exercise sessions prescribed for 2 weeks or more.

  Through study completion, an average of 18 months

• Acceptability of the exercise intervention: more than 50% of the patients approached

  The exercise intervention will be considered acceptable if more than 50% of the patients approached agree to receive at least the first exercise session.

  During recruitment

• Safety of the exercise intervention: questionnaire

  Within the questionnaire we will assess whether musculoskeletal occur (yes/no; ongoing; location; severity (mild-life threatening); daily activities affected). The intervention will be considered as safe if less than 25% of included patients report mild musculoskeletal impairments and less than 5% experienced musculoskeletal injuries (defined as symptoms lasting a week or longer and or requiring the attention of a medical professional).

  Through the study completion, an average of 18 months

Secondary Outcomes (13)

• 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)

  Through study completion, an average of 18 months

• Bone Marrow Transplant-related Quality of Life: EORTC QLQ-HDC29

  Through study completion, an average of 18 months

• Fatigue

  Through study completion, an average of 18 months

• Sleep

  Through study completion, an average of 18 months

• Depression

  Through study completion, an average of 18 months

Study Arms (2)

Home-Based Prehabilitation

ACTIVE COMPARATOR

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.

Behavioral: Exercise

Prehabilitation Education

ACTIVE COMPARATOR

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

Behavioral: Prehabilitation Education

Interventions

Exercise 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).

Home-Based Prehabilitation

Prehabilitation Education BEHAVIORAL

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

Prehabilitation Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

• 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.

  PMID: 36657760 DERIVED

MeSH Terms

Conditions

Hematologic Diseases; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kathryn Schmitz, PhD

  Penn State College of Medicine, Hershey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Public Health Science

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 22, 2019
• Study Start: June 28, 2019
• Primary Completion: April 13, 2023
• Study Completion: April 13, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)