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Hematopoietic Stem Cell TransplantIMPROVE-BMTNCT03886909

Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant

A study testing Exercise and Prehabilitation Education in people with Hematopoietic Stem Cell Transplant and Hematologic Diseases, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Exercise and Prehabilitation Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteUnited States
Study dates
28 Jun 2019to 13 Apr 2023
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Scheduled for an inpatient autologous or allogeneic stem cell transplant at Penn State Cancer Institute
  • ≥ 2 weeks until scheduled transplant
  • Primary attending physician approval

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site
  • Penn State Cancer Institute

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: The Effects of a Prehabilitation Exercise Program in Adults Receiving a Hematopoietic Stem Cell Transplant

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.

Read the 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.

Being tested
Exercise, Prehabilitation Education
Keywords
Exercise, Hematopoietic Stem Cell Transplant, Physical function, Quality of Life
Medical subject headings
Hematologic Diseases, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    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 EducationBehavioural

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

Study groups in NCT03886909
Study groupRoleWhat they receive
Home-Based PrehabilitationActive comparatorWill 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.
Receives: Behavioral: Exercise
Prehabilitation EducationActive comparatorWill be offered a prehabilitation and stem cell education class at the Penn State Hershey Cancer Institute.
Receives: Behavioral: Prehabilitation Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of 18 months

  2. 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.

    Measured: During recruitment

  3. 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).

    Measured: Through the study completion, an average of 18 months

Secondary outcomes (13)
  1. 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)

    QoL will be assessed with the validated 30-item self-assessment questionnaire of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0).

    The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Measured: Through study completion, an average of 18 months

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

    Quality of Life will be assessed with the validated 29-item self-assessment questionnaire of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- High Dose Chemotherapy- 29 Items (EORTC QLQ-HDC29).

    The QLQ HDC29 module includes 29 items, consisting of six multi-item scales and eight single-items. For the multi-item scales and single-item scales a high score is equivalent to worse or more symptoms/problems.

    Measured: Through study completion, an average of 18 months

  3. Fatigue

    Fatigue will be assessed with the Multidimensional Fatigue Inventory (MFI) which is a 20-item, multidimensional self-assessment questionnaire.

    Respondents use a scale ranging from 1 to 7 to indicate how aptly certain statements regarding fatigue represent their experiences. Higher total scores correspond with more acute levels of fatigue.

    Measured: Through study completion, an average of 18 months

  4. Sleep

    Sleep quality and sleep problems will be assessed with the validated and frequently used Pittsburgh Sleep Quality Index (PSQI).

    In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

    Measured: Through study completion, an average of 18 months

  5. Depression

    Depressive symptoms will be assessed with the 20-item Center for Epidemiological Studies Depression Scale (CES-D).

    Zero for 'Rarely', 1 for 'Some or a little of the time', 2 for 'Occasionally or a moderate amount of time', 3 for 'Most or all of the time'. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.

    Measured: Through study completion, an average of 18 months

  6. Short Questionnaire to Assess Health-Enhancing Physical Activity

    Physical activity behavior in the domains of commuting activity, leisure time activities such as cycling, walking, and sports, household and occupational activity will be assessed via a standardized and validated questionnaire, the Short QUestionnaire to ASsess Health-enhancing Physical Activity (SQUASH).

    Household work and activities at work or school were prestructured for intensity. A basic intensity score of 2 and 5 for light and intense activities, respectively. Total minutes of activity are calculated for each question by multiplying frequency (days/week) by duration (min/day). Activity scores for separate questions are calculated by multiplying total minutes of activity by the intensity score. The total activity score is calculated by taking the sum of the activity scores for separate questions. Higher values equals more time spent completing the activity.

    Measured: Through study completion, an average of 18 months

  7. Godin Physical Activity Questionnaire

    Physical activity behavior in the domains of commuting activity, leisure time activities such as cycling, walking, and sports, household and occupational activity will be assessed via a standardized and validated questionnaire, the Godin Physical Activity Questionnaire.

    Total weekly leisure activity is calculated in arbitrary units by summing the products of the separate components, as shown in the following formula:

    Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light) Higher activity score = more active

    Measured: Through study completion, an average of 18 months

  8. Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events

    Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be used to collect information on severity and interference of symptoms and adverse events.

    Measured: Through study completion, an average of 18 months

  9. Body Pain: Brief Pain Inventory- Short form

    Bodily pain will be assessed using the Brief Pain Inventory- Short form (BPI-SF).

    The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70.

    Measured: Through study completion, an average of 18 months

  10. Physical Function: Short Physical Performance Battery

    Objectively-measured physical function will be assessed using the Short Physical Performance Battery (SPPB).

    The SPPB is an accumulation of balance tests, 4-meter gait speed, and 5-chair stands. Based on the time needed to complete the chair stands, a score is given. A summation of scores from all tests is taken, ranging from 0 -12. A higher score = Higher physical function.

    Measured: Through study completion, an average of 18 months

  11. Aerobic Capacity: Six Minute Walk Test

    Objectively-measured physical function will be assessed using the Six Minute Walk Test (6MWT).

    Distance walked during 6 minutes (measured in meters) is measured. Longer distance = higher aerobic capacity.

    Measured: Through study completion, an average of 18 months

  12. Physical Function: Timed-Up-and-Go Test

    Objectively-measured physical function will be assessed using the Timed-Up-and-Go test (TUG).

    Time taken to stand up from a chair, walk 10 meters around an obstacle, and return to seated position is measured in seconds. Lower time = better physical function.

    Measured: Through study completion, an average of 18 months

  13. Fall Risk

    Functional balance will be assessed using the Berg Balance Scale.

    Scoring: A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Score is summation of all items. Highest Total Score = 56 Interpretation: 0-20: Wheelchair bound; 21-40: Walking with assistance; 41-56: Independent

    Measured: Through study completion, an average of 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2019
  2. Study start28 Jun 2019
  3. Primary completion13 Apr 2023
  4. Study completion13 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03886909
Sponsor's protocol ID
STUDY00010914
Acronym
IMPROVE-BMT
Status last verified
Jul 2023
First submitted
12 Mar 2019
Last updated
11 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36657760

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