Cancer Survivors Acute Exercise Response 1

NCT03903848 | Unknown

• 1 other identifier: STUDY00001419
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aims of this study examine the immune system, muscle metabolism, and autonomic nervous system response to an acute bout of exercise. Cancer survivors will participate in an acute bout of exercise. Blood samples will be collected before the exercise bout and at two time points after the exercise bout to assess the proposed variables.

Conditions

Neoplasms Malignant

Outcome Measures

Primary Outcomes (4)

• Exercise-induced response of circulating monocytes

  Circulating serum monocyte phenotype before and after one exercise session

  Pre-exercise, change from pre-exercise to immediately post-exercise, change from pre-exercise to 1hr post-exercise, change from immediately post-exercise to 1hr post-exercise

• Exercise-induced response of circulating T cells

  Circulating serum T cells phenotype before and after one exercise session

  Pre-exercise, change from pre-exercise to immediately post-exercise, change from pre-exercise to 1hr post-exercise, change from immediately post-exercise to 1hr post-exercise

• Exercise-induced response of circulating Follistatin

  Circulating serum follistatin before and after one exercise session

  Pre-exercise, change from pre-exercise to immediately post-exercise, change from pre-exercise to 1hr post-exercise, change from immediately post-exercise to 1hr post-exercise

• Exercise-induced response of circulating GDF-15

  Circulating serum growth differentiation factor 15 before and after one exercise session

  Pre-exercise, change from pre-exercise to immediately post-exercise, change from pre-exercise to 1hr post-exercise, change from immediately post-exercise to 1hr post-exercise

Secondary Outcomes (2)

• Body composition

  before exercise

• Body weight

  before exercise

Study Arms (1)

Exercise session

EXPERIMENTAL

One session of physical exercise

Other: Exercise

Interventions

Exercise OTHER

Single session of treadmill walking and resistance exercise

Exercise session

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 40-70 years
• At least two years past detectible cancer (two years disease-free survival)
• Have received chemotherapy and/or radiation as part of their cancer treatment
• All cancers were of the organs/non-blood producing tissues (not blood/hematologic cancers) and while they were an adult (no history of pediatric cancer)
• Meeting ACSM-AHA guidelines for exercise (150 minutes per week of cardiorespiratory fitness type exercises and \~two days per week of resistance training), as confirmed by a combination of a physical activity questionnaire and a cardiorespiratory fitness classification of "good" or higher (age and sex matched)
• A BMI between 20-33 kg·m-2
• Able to speak and read English

You may not qualify if:

• Participants may not:
• Have any contraindications to moderate to vigorous exercise
• Have any recent illness or have been instructed not to exercise by a healthcare provider
• Participants may not have range of motion restrictions that would prevent them from participating in aerobic or resistance training with proper form (they must be ambulatory)
• Be taking medications (prescription or over the counter) known to influence immune function (including daily NSAID's and beta blockers), cholesterol-lowering medications (statins), drugs that increase bone mass (bisphosphonates), or steroids.
• Have known cardiovascular, respiratory, metabolic, or renal disease, with the exception of controlled hypertension (as defined by resting BP below 140/90) and/or controlled asthma (self-reported).
• Be pregnant
• Be unable to complete all visits (i.e. must not be planning to leave the Houston area long-term before concluding their participation in the study)
• Fall outside of a BMI range of (20 - 33)
• Consume alcohol or recreational drugs for 24h prior to visits
• Participants must not have scheduling conflicts that would prevent them from reporting to the laboratory of integrated physiology 2-3 times over the course of the study

Sponsors & Collaborators

• University of Houston: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

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

Study Officials

• Melissa M Markofski

  University of Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Markofski, PhD

CONTACT

7137436658; mmarkofski@uh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 4, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2023
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon publication
• Access Criteria: If when submitting manuscript for publication, the journal requires the release of data then the data will be shared (exact method will be consistent with journal policy, but may include inclusion as a supplementary figure or depositing in a data repository suggested by the journal)