Effect of physical activity on menopausal symptoms
| ISRCTN | ISRCTN54690027 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54690027 |
| Protocol serial number | N/A |
| Sponsor | The Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research (Finland) |
| Funders | Academy of Finland (Finland), Ministry of Health and Education (Finland), Pirkanmaa Competitive Research Fund (Finland), Yrjö Jansson Foundation (Finland), Juho Vainio Foundation (Finland) |
- Submission date
- 10/12/2008
- Registration date
- 17/12/2008
- Last edited
- 14/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
UKK Institute for Health Promotion
PO Box 30
Kaupinpuistonkatu 1
Tampere
33501
Finland
| Phone | +358 (0)3 282 9226 |
|---|---|
| riitta.luoto@uta.fi |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of physical activity on menopausal symptoms: a randomised clinical trial |
| Study objectives | 1. Increasing physical activity alleviates menopausal symptoms. 2. Physical activity increases quality of life of menopausal women through alleviating menopausal symptoms |
| Ethics approval(s) | Pirkanmaa Hospital District Ethics Committee, 02/12/2008, ref: R07199 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Other menopausal symptoms, such as urogenital and cognitive symptoms |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 200 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 11/01/2009 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Finland
Study participating centre
33501
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2012 | Yes | No | |
| Results article | results | 01/09/2012 | Yes | No | |
| Results article | results | 11/09/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
