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

NCT01282320 | Completed

• 1 other identifier: REK2009/1429
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Postmenopausal Symptoms; Hot Flashes

Keywords

Randomized Controlled Trial; Clinical Tria; Postmenopause; Hot-flashes; Quality of life; Physical Fitness

Outcome Measures

Primary Outcomes (1)

• Change in mean hot-flashes frequency and intensity (per 24/hours).

  Potential participants receive a diary by mail and are asked to record frequency and severity of hot flashes and duration of sleep at night for a period of 14 subsequent days. During the study period the participants record frequency and intensity of hot flashes and duration of sleep at night for a period of 7 subsequent days at 4, 8, 12, 16 weeks and 6 months and one year.

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks , 6 months and 1 year

Secondary Outcomes (6)

• Quality of life measured with Women's Health Questionnaire (WHQ) 23 items.

  Baseline, 16 weeks, 6 months, one year.

• Depressive symptoms are measured with Beck Depression Inventory -II (BDI-II)

  Baseline, 16 weeks, 6 months

• Dysfunctional attitudes related to cognitive vulnerability to depression.

  Baseline, 16 weeks, 6 months

• Increased physical fitness, measured as 10 % increase in VO2-max

  Baseline, 16 weeks

• Motivation for change in physical activity - Stages of Change

  Baseline, 16 uker, 6 months and one year

Study Arms (2)

Increased Physical Activity

EXPERIMENTAL

Individually tailored training one hour, 2-3 sessions per week.

Behavioral: Physical activity intervention program

Activity as usual ("Buisness as usual")

NO INTERVENTION

Interventions

Physical activity intervention program BEHAVIORAL

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

Also known as: Postmenoapsual symptoms, VO2-max, Physical fitness

Increased Physical Activity

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal
• Natural or induced menopause
• \> 12 months since last menstruation
• Severe hot flushes (frequency and intensity)
• Sedentary life style
• Motivated to increase level of physical activity

You may not qualify if:

• Current use of estrogen/progesterone treatment.
• Physical active (mean activity last six months
• More than 30 min per regularly exercise sessions at least once a week.
• Regular exercise sessions are defined as any planned physical activity (e.g., brisk walking, aerobics, jogging, bicycling, swimming, rowing, etc.) performed to increase physical fitness. BMI \> 35 kg/m2, disease of illness that can hamper regular training.
• Current use of HT (systemic or plaster) during last 8 weeks

Sponsors & Collaborators

• University Hospital of North Norway: lead
• University of Tromso: collaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Physical Fitness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health; Population Characteristics

Study Officials

• Sameline Grimsgaard, MD, PhD

  University Hospital North Norway

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 24, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: December 1, 2013
• Last Updated: July 1, 2019

Record last verified: 2013-07

Locations

NO (1)