Evaluation of Cardiorespiratory Performance After Interval Exercise Training Prior to Hematopoietic Cell Transplantation

NCT02577939 | Completed DMC

• 1 other identifier: LCCC 1311
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to demonstrate the efficacy of a pre-transplant, interval exercise training (IET) intervention, in increasing peak oxygen uptake (VO2peak) scores on cycle ergometry. This study will have a lead-in phase to ensure that IET is feasible in this population. Secondary objectives include documenting the safety of IET in this population, evaluating the correlation of VO2peak with other methods of measuring pre-transplant cardiorespiratory performance, comparing the 6 minute walk distance (6MWD) pre and post IET, and establishing the feasibility of the 6MWD when performed unsupervised by a health care professional. Eligible patients include 40 evaluable autologous (n=20) and allogeneic (n=20; 10 full intensity and 10 reduced intensity) transplant patients deemed appropriate for exercise intervention by their treating physician. The investigators will enroll no more than 50 patients onto this trial. Results of this study will inform a randomized, multi-site study of a pre-transplant exercise intervention.

Conditions

Stem Cell Transplantation, Hematopoietic

Outcome Measures

Primary Outcomes (1)

• Of those patients with heart rate data, number and percent of patients able to achieve 65-85% heart rate during one or more exercise sessions. Unit of measurement: number of patients and percent of patients with evaluable heart rate data.

  Establish the feasibility of IET in patients prior to autologous or allogeneic transplantation. Feasibility is defined as 5 of the first 10 evaluable patients being able to achieve 65-85% heart rate during one or more exercise sessions throughout the duration of the interval exercise training.

  During the 6 weeks of IET pre-transplant

Secondary Outcomes (3)

• Number of adverse events as reported by patients and determined by study investigators. Unit of measurement: cumulative number of adverse events.

  During the 6 weeks of IET pre-transplant

• Change in 6 minute walk distance based on pre- and post- intervention 6 minute walk distance testing. Unit of measurement: meters.

  Pre- and Post- Assessment for 6 weeks of IET

• Change in VO2peak based on pre- and post- intervention VO2peak measurement from cardiopulmonary exercise testing. Unit of measurement: ml/kg*min.

  Pre- and Post- Assessment for 6 weeks of IET

Study Arms (1)

Interval Exercise Training (IET)

EXPERIMENTAL

This is a single arm study. All patients receive the intervention of 6 weeks of pre-transplant IET, pre- and post-tests, and data collection via FitBit accelerometer and weekly surveys.

Behavioral: Interval Exercise Training (IET)

Interventions

Interval Exercise Training (IET) BEHAVIORAL

This is a single arm study. All patients receive the intervention of 6 weeks of pre-transplant IET, pre- and post-tests, and data collection via FitBit accelerometer and weekly surveys.

Also known as: Aerobic Training, Aerobic Exercise, Endurance Training

Interval Exercise Training (IET)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Not currently participating in IET training
• Willing and able to provide signed, informed consent
• Planned autologous or allogeneic stem cell transplant with schedule that accommodates a 6 week exercise intervention
• Willing to participate in an IET program that will last 6 weeks.
• Subject must complete at least one interval exercise session during the 6 weeks in order to be eligible for analysis.
• Planning to undergo transplant but continuing to receive cycles of chemotherapy on a previously started regimen while awaiting transplant

You may not qualify if:

• Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent
• Received erythropoiesis-stimulating proteins (ESPs) within 4 weeks prior to enrollment

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Interventions

Exercise; Endurance Training

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• William A Wood, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: October 16, 2015
• Study Start: June 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

US (1)