Contact information
Type
Scientific
Primary contact
Dr Riitta Luoto
ORCID ID
Contact details
UKK Institute for Health Promotion
PO Box 30
Kaupinpuistonkatu 1
Tampere
33501
Finland
+358 (0)3 282 9226
riitta.luoto@uta.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of physical activity on menopausal symptoms: a randomised clinical trial
Acronym
Study hypothesis
1. Increasing physical activity alleviates menopausal symptoms.
2. Physical activity increases quality of life of menopausal women through alleviating menopausal symptoms
Ethics approval
Pirkanmaa Hospital District Ethics Committee, 02/12/2008, ref: R07199
Study design
Randomised controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Menopausal symptoms
Intervention
Intervention:
Moderate intensity aerobic training for 6 months, 4 times per week walking (or Nordic walking) for 50 minutes at 60% of maximal oxygen uptake (VO2max).
Control:
Continue earlier habits.
Duration of follow-up is 6 months for both arms.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Vasomotor symptoms as measured with validated scale (Women's Health Questionnaire [WHQ]). WHQ enables assessment of depression, anxiety, sleep problems, somatic symptoms with optional subscales for menstrual problems and sexual difficulties.
Timepoint of the measurements is 0 and 6 months; baseline and end of the trial in both primary and secondary outcomes.
Secondary outcome measures
1. Other menopausal symptoms, such as urogenital and cognitive symptoms
2. Physical activity and health-related physical fitness (estimated maximal oxygen consumption, muscle strength)
3. Components of metabolic syndrome (weight, waist circumference, and fasting plasma high density lipoprotein [HDL] cholesterol, triglycerides, glucose and insulin)
4. Workability
Timepoint of the measurements is 0 and 6 months; baseline and end of the trial in both primary and secondary outcomes.
Overall trial start date
11/01/2009
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Symptomatic (severe or very severe or moderate daily hot flushes) women
2. Aged 40 - 60 years
3. No current use of oestrogen hormone treatment (HT, without or with progesterone) or any other treatment or withdrawal (wash-out period 3 months)
4. Sedentary (physical exercise less than twice weekly)
5. Six to 36 months from last menstruation (peri-menopausal)
6. Follicle stimulating hormone (FSH) elevated (at least 30 IU/l)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100 for the exercise group, 100 for comparison group
Participant exclusion criteria
1. Physically active women (greater than two times/week, at least 30 minutes)
2. Body mass index (BMI) greater than 35 kg/m^2
3. Coronary heart disease, orthopaedic or other diseases preventing from exercising
Recruitment start date
11/01/2009
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Finland
Trial participating centre
UKK Institute for Health Promotion
Tampere
33501
Finland
Sponsor information
Organisation
The Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research (Finland)
Sponsor details
PO Box 30
Kaupinpuistonkatu 1
Tampere
33501
Finland
+358 (0)3 282 9226
riitta.luoto@uta.fi
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Academy of Finland (Finland)
Alternative name(s)
Suomen Akatemia, Finlands Akademi
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Finland
Funder name
Ministry of Health and Education (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pirkanmaa Competitive Research Fund (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Yrjö Jansson Foundation (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Juho Vainio Foundation (Finland)
Alternative name(s)
Juho Vainio Foundation, Reppy Institute
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Finland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22673453
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/21639722
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26362664
Publication citations
-
Results
Mansikkamäki K, Raitanen J, Nygård CH, Heinonen R, Mikkola T, EijaTomás, Luoto R, Sleep quality and aerobic training among menopausal women--a randomized controlled trial., Maturitas, 2012, 72, 4, 339-345, doi: 10.1016/j.maturitas.2012.05.003.
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Luoto R, Moilanen J, Heinonen R, Mikkola T, Raitanen J, Tomas E, Ojala K, Mansikkamäki K, Nygård CH, Effect of aerobic training on hot flushes and quality of life--a randomized controlled trial., Ann. Med., 2012, 44, 6, 616-626, doi: 10.3109/07853890.2011.583674.
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Results
Mansikkamäki K, Raitanen J, Nygård CH, Tomás E, Rutanen R, Luoto R, Long-term effect of physical activity on health-related quality of life among menopausal women: a 4-year follow-up study to a randomised controlled trial, BMJ Open, 2015, 5, 9, e008232, doi: 10.1136/bmjopen-2015-008232.