RECRUITING

The Cardiovascular Impact of Hot Flushes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The overall objective of this study is to examine the physiological responses that occur during a hot flush in postmenopausal women. The following specific aims will be executed to reach the overall objective of this study. Aim 1: To determine if hot flushes can be reliably induced with a temperature-controlled, water- circulating (TCWC) heating pad. Based on previous research, the investigators hypothesize that hot flushes will be inducible with the TCWC in symptomatic women, but not in asymptomatic women. Aim 2: To determine if heat-induced hot flushes in symptomatic women will cause reproducible cardiovascular and respiratory responses. The investigators hypothesize that heat-induced hot flushes produce similar and reproducible cardiovascular and respiratory responses to spontaneous hot flushes. Aim 3: To determine if body fat percentage influences hot flush severity or frequency during spontaneous or induced hot flushes. The investigators hypothesize that women with higher body fat have reduced hot flash severity and frequency.

Official Title

The Cardiovascular Impact of Hot Flushes

Quick Facts

Study Start:2022-03-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05251324

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 70 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Postmenopausal (may have or may not have hot flushes)
  2. * Have not started hormone therapy and/or will discontinue hormone therapy for the duration of the study
  1. * Reported nicotine/tobacco use within the last six months
  2. * Diabetic or asthmatic
  3. * Diagnosed significant carotid stenosis
  4. * History of significant autonomic dysfunction, heart disease, respiratory disease, or severe neurologic condition such as stroke or traumatic brain injury
  5. * Existing metabolic or endocrine abnormalities
  6. * Use of heart/blood pressure medications that are determined to interfere with study outcomes
  7. * Unwilling to discontinue use of OC (or other hormonal contraceptives, including intrauterine devices or contraceptive implants) and/or MHT
  8. * Pregnant or breastfeeding
  9. * Unwilling or unable to refrain from consuming caffeine or alcohol in the 12 hours before visit two or three
  10. * Unwilling or unable to refrain from vigorous exercise (at least 10 minutes in duration) in the 12 hours before visit two or three
  11. * Unwilling or unable to fast in the eight hours before visit two or three
  12. * Body mass index greater than or equal to 35 kg/m\^3

Contacts and Locations

Study Contact

Manda Keller-Ross, PhD, DPT, PT
CONTACT
(612) 625-3175
kell0529@umn.edu
William Stokes
CONTACT
(443) 801-8778
stoke123@umn.edu

Principal Investigator

Manda Keller-Ross, PhD, DPT, PT
PRINCIPAL_INVESTIGATOR
University of Minnesota Medical School Department of Rehabilitation Medicine

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Manda Keller-Ross, PhD, DPT, PT, PRINCIPAL_INVESTIGATOR, University of Minnesota Medical School Department of Rehabilitation Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-03-01
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Menopause

Additional Relevant MeSH Terms

  • Hot Flashes
  • Menopause