Postmenopausal SymptomsWHATNCT01282320
WHAT (Women, Hot-flashes, Activity, Trial) - Physical Activity for Treatment of Hot Flushes Among Postmenopausal Women
A study testing Physical activity intervention program in people with Postmenopausal Symptoms and Hot Flashes, run by University Hospital of North Norway at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Symptoms, Hot Flashes
- What is being tested?
- Physical activity intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: WHAT - Effectiveness of Physical Activity for Treatment of Hot Flushes Among Postmenopausal Women. A Randomized Controlled Pragmatic Pilot Study
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.
Read the detailed description
The WHAT study is a pragmatic randomized controlled trial with two parallel arms. The intervention is a 16 weeks individually tailored training programme with one hour physical activity 2-3 times per week. Women randomized to the control group are asked to keep physical activity at the same level as before the study.
Healthy postmenopausal women from Tromso will be recruited to the study by newspaper advertisements and media coverage. Interested women are asked to make a call. A staff member will ask about menopausal status, level of physical activity and diseases. Potential participants will receive a diary by mail and will be asked to record frequency and severity of hot-flashes, and duration of sleep at night for a period of 14 days. Women who return this diary will be asked to sign the informed consent and complete a questionnaire, before the fitness test. Baseline fitness is an important measure in this study. We will measure VO2-max (maximal oxygen consumption) as a proxy for fitness. Whether you are randomized to intervention or control group can influence the fitness test. The participants will therefore be randomized after the fitness test.
Randomization: Unit of Applied Clinical Research, Institute of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway, will develop and administrate a web-based randomization system for the WHAT pilot study. The data base will be located at a server at the Medical Faculty at Norwegian University of Science and Technology in Trondheim. The following staff are authorized to randomize people in WHAT pilot study: Sameline Grimsgaard, Merethe Kumle, Sissel Andersen , Jorid Degerstrøm, Svein Arne Pettersen
In this pilot 50 women will be randomized either to intervention group (25 women) or control group (25 women).
Elements in the intervention: A physiotherapist will based on interview and physical examination make a plan for the 16 weeks physical activity programme for each participant. The program will start with Pilates classes and low intensity aerobic training (2-4 weeks). After this period, classes with moderate to high intensity aerobic training will be introduced. The aim of the intervention is to increase aerobic capacity with 10 % from baseline.
Both the intervention group and the control group will receive questionnaires at baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 6 months and 1 year after inclusion. We will run the test for physical fitness at baseline and 16 weeks.
- Conditions
- Postmenopausal Symptoms, Hot Flashes
- Being tested
- Physical activity intervention program
- Keywords
- Randomized Controlled Trial, Clinical Tria, Postmenopause, Hot-flashes, Quality of life, Physical Fitness
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity intervention programBehavioural
Also called Postmenoapsual symptoms, VO2-max, Physical fitness
Individually tailored exercise programme (combination of pilates and aerobe training) with one hour activity sessions two-three times per week in 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Increased Physical Activity | Experimental | Individually tailored training one hour, 2-3 sessions per week. Receives: Behavioral: Physical activity intervention program |
| Activity as usual ("Buisness as usual") | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
We will measure quality of life with Women's Health Questionnaire. This is a self-administered questionnarie. A Norwegian version has been validated psychometric and linguistically.
Measured: Baseline, 16 weeks, 6 months, one year.
Depressive symptoms are measured with Beck Depression Inventory -II (BDI-II)
The Beck Depression Inventory - Second Edition (BDI-II; Beck et al., 1996) is a 21-item self-report inventory designed to assess the presence and severity of depressive symptoms and is rated on a four-point Likert-type scale ranging from 0 to 3, reflecting the severity of each item. The BDI-II scores are classified as following: 0-13 minimal; 14-19 mild; 20-28 moderate; and 29-63 severe (Beck et al., 1996). A full description of the inventory including psychometric properties can be found in Steer, Ball, Ranieri, and Beck (1999).
Measured: Baseline, 16 weeks, 6 months
Dysfunctional attitudes related to cognitive vulnerability to depression.
The Dysfunctional Attitude Scale (DAS)(Form A) (DAS; Weisman \& Beck, 1978) is a 40-item self-report inventory to be rated along a seven-point Likert scale ranging from "totally agree" to "totally disagree", designed to assess the presence of dysfunctional attitudes that may relate to cognitive vulnerability to depression (Oliver \& Baumgart, 1985). A full description including psychometric properties is provided by Chioqueta and Stiles (2004), Dobson and Breiter (1983) and Oliver and Baumgart (1985).
Measured: Baseline, 16 weeks, 6 months
Increased physical fitness, measured as 10 % increase in VO2-max
Physical fitness will be tested at the Regional Centre for Sport and Health, University of Tromsø, at baseline and after 16 weeks. VO2-max is used as a proxy for physical fitness.
Measured: Baseline, 16 weeks
Motivation for change in physical activity - Stages of Change
Permanent changes of behavior is difficult. We will use instruments from the Transtheoretical Model of Change, the Stages of Change short and long form to evaluate motivation for increased physical activity among the participants in the WHAT pilot study. The instrument might give valuable information about who a prone drop-out during study period.
Measured: Baseline, 16 uker, 6 months and one year
Physical activity, motivation and experiences
During the study period approximately 20 women (both from the intervention group and the control group) will be asked to participate i a qualitative study of physical activity, motivation and experiences.
Measured: Betwen 2nd and 16th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Responsible party
- Sponsor
- Investigators
- Sameline Grimsgaard, MD, PhD, Principal investigator, University Hospital North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282320
- Sponsor's protocol ID
- REK2009/1429
- Acronym
- WHAT
- Status last verified
- Jul 2013
- First submitted
- 21 Jan 2011
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WHAT - Effectiveness of Physical Activity for Treatment of Hot Flushes Among Postmenopausal Women. A Randomized Controlled Pragmatic Pilot Study
- ClinicalTrials.gov ID
- NCT01282320
- Acronym / sponsor ID
- WHAT / REK2009/1429
- Conditions
- Postmenopausal Symptoms, Hot Flashes
- Keywords
- Randomized Controlled Trial, Clinical Tria, Postmenopause, Hot-flashes, Quality of life, Physical Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The WHAT study is a pragmatic randomized controlled trial with two parallel arms. The intervention is a 16 weeks individually tailored training programme with one hour physical activity 2-3 times per week. Women randomized to the control group are asked to keep physical activity at the same level as before the study.
Healthy postmenopausal women from Tromso will be recruited to the study by newspaper advertisements and media coverage. Interested women are asked to make a call. A staff member will ask about menopausal status, level of physical activity and diseases. Potential participants will receive a diary by mail and will be asked to record frequency and severity of hot-flashes, and duration of sleep at night for a period of 14 days. Women who return this diary will be asked to sign the informed consent and complete a questionnaire, before the fitness test. Baseline fitness is an important measure in this study. We will measure VO2-max (maximal oxygen consumption) as a proxy for fitness. Whether you are randomized to intervention or control group can influence the fitness test. The participants will therefore be randomized after the fitness test.
Randomization: Unit of Applied Clinical Research, Institute of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway, will develop and administrate a web-based randomization system for the WHAT pilot study. The data base will be located at a server at the Medical Faculty at Norwegian University of Science and Technology in Trondheim. The following staff are authorized to randomize people in WHAT pilot study: Sameline Grimsgaard, Merethe Kumle, Sissel Andersen , Jorid Degerstrøm, Svein Arne Pettersen
In this pilot 50 women will be randomized either to intervention group (25 women) or control group (25 women).
Elements in the intervention: A physiotherapist will based on interview and physical examination make a plan for the 16 weeks physical activity programme for each participant. The program will start with Pilates classes and low intensity aerobic training (2-4 weeks). After this period, classes with moderate to high intensity aerobic training will be introduced. The aim of the intervention is to increase aerobic capacity with 10 % from baseline.
Both the intervention group and the control group will receive questionnaires at baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 6 months and 1 year after inclusion. We will run the test for physical fitness at baseline and 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Increased Physical Activity | Experimental | Behavioral: Physical activity intervention programIndividually tailored training one hour, 2-3 sessions per week. |
| Activity as usual ("Buisness as usual") | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Postmenopausal
- Natural or induced menopause
- > 12 months since last menstruation
- Severe hot flushes (frequency and intensity)
- Sedentary life style
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity intervention programAlso: Postmenoapsual symptoms, VO2-max, Physical fitnessIndividually tailored exercise programme (combination of pilates and aerobe training) with one hour activity sessions two-three times per week in 16 weeks. | Behavioural | Increased Physical Activity |
Primary outcome
Change in mean hot-flashes frequency and intensity (per 24/hours).
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks , 6 months and 1 year
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.
6 secondary outcomes
Quality of life measured with Women's Health Questionnaire (WHQ) 23 items.
Time frame: Baseline, 16 weeks, 6 months, one year.
Depressive symptoms are measured with Beck Depression Inventory -II (BDI-II)
Time frame: Baseline, 16 weeks, 6 months
Dysfunctional attitudes related to cognitive vulnerability to depression.
Time frame: Baseline, 16 weeks, 6 months
Increased physical fitness, measured as 10 % increase in VO2-max
Time frame: Baseline, 16 weeks
Motivation for change in physical activity - Stages of Change
Time frame: Baseline, 16 uker, 6 months and one year
Physical activity, motivation and experiences
Time frame: Betwen 2nd and 16th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
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Self-Management Box on Hot Flash in Postmenopausal Women
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameline Grimsgaard, MD, PhD principal investigator
University Hospital North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention program in people with Postmenopausal Symptoms and Hot Flashes, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean hot-flashes frequency and intensity (per 24/hours). (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks , 6 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019; AzTrials last refreshed its copy on 26 Oct 2026.