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WHAT (Women, Hot-flashes, Activity, Trial) - Physical Activity for Treatment of Hot Flushes Among Postmenopausal Women

NCT01282320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-07-01

No results posted yet for this study

Summary

More than 60 % of women experience hot-flashes during postmenopausal and 20 % have serious symptoms. Use of combined estrogen/progesterone therapy reduces hot-flashes effectively. In 2001, results from the randomized controlled WHI-study (Womens Health Initiative) showed increased risk for breast cancer and hearth-disease among users of combined estrogen/progesterone therapy. This reduced the use of combined estrogen/progesterone therapy. Many women seek alternative treatment for hot-flashes. They are often told that physical activity can reduce intensity and frequency of hot-flashes. The evidence for this advice is sparse.

The primary hypothesis tested in the WHAT-study will be: Increased physical activity reduce frequency and intensity of hot-flushes among sedentary postmenopausal women with bothersome hot-flushes.

The WHAT-study is designed as a pragmatic randomized controlled clinical trial. To answer the primary hypothesis we will need approximately 500 participants. The logistic in a pragmatic trial of a complex intervention are complicated and we decided to first run a pilot study with 50 participants as a feasibility study. The pilot gives us opportunity to gain experience with possible problems like withdrawals and injuries.

Conditions

Interventions

BEHAVIORAL

Physical activity intervention program

Individually tailored exercise programme (combination of pilates and aerobe training) with one hour activity sessions two-three times per week in 16 weeks.

Sponsors & Collaborators

  • University of Tromso

    collaborator OTHER

  • University Hospital of North Norway

    lead OTHER

Principal Investigators

  • Sameline Grimsgaard, MD, PhD · University Hospital North Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-03-31
Completion
2013-12-31

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01282320 on ClinicalTrials.gov