The effect of a combined physical exercise on cognitive function and mental health in women after menopause
| ISRCTN | ISRCTN13086152 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13086152 |
| Secondary identifying numbers | 0557/E5.5/AL.04/2023 |
- Submission date
- 29/12/2023
- Registration date
- 04/01/2024
- Last edited
- 15/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
After menopause, women are more susceptible to a decline in cognitive function compared to men. Exercise is one of the methods used to prevent a rapid decline in cognitive function in older adults. However, the benefits of exercise on cognition vary depending on the doses of exercise intervention (type, intensity, and duration) and the characteristics of the population (gender, general health, and fitness level). A recent study suggests that combining different types of exercises, such as cardiovascular, resistance, balance, and flexibility exercises, might achieve greater improvements in cognitive function. However, there is little evidence of the benefits that come with exercise training specifically for post-menopausal women. This study aims to see if the combined exercise training program consisting of aerobic (brisk walking), resistance, flexibility, and balance exercises, can improve cognitive function in post-menopausal women.
Who can participate?
Female participants between the ages of 50 and 80 years who are at least 12 months postmenopausal, have a minimum educational level of junior high school, and are in good health
What does the study involve?
Initially, participants will take several tests, including a psychological assessment to evaluate mental health and cognitive abilities. They will also have tests for their body weight and height, heart rate, blood pressure, and blood test for glucose levels. After that, participants in the exercise group will engage in exercise training five times per week for two weeks. The duration of the exercise session is 40 to 60 minutes.
What are the possible benefits and risks of participating?
Participants in this study are expected to experience improved fitness and potentially enhanced cognitive abilities after completing the exercise training. At the end of this study, all participants will receive compensation in the form of souvenirs, which will include the sports equipment they used during the study (such as a yoga mat and resistance bands). There is a potential risk of injury during physical exercise. This will be minimized by using the correct warming-up and cooling-down techniques. The exercise session will also be supervised by a trained exercise physiologist.
Where is the study run from?
Airlangga University (Indonesia)
When is the study starting and how long is it expected to run for?
November 2022 to April 2023
Who is funding the study?
Ministry of Research, Technology and Higher Education of the Republic of Indonesia
Who is the main contact?
Dr Raden Argarini, Raden-a@fk.unair.ac.id
Contact information
Public, Scientific, Principal Investigator
Jl. Mayjen Prof. Dr. Moestopo No. 47
Surabaya
60132
Indonesia
 ORCID ID |
0000-0002-5908-6270 |
|---|---|
| Phone | +62 (0)315023621 |
| raden-a@fk.unair.ac.id |
Study information
| Study design | Single-center interventional single-blinded non-randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Quality of life, Treatment |
| Participant information sheet | Not available in webformat, please use contact details to request a participant information sheet |
| Scientific title | The effect of combination exercise on cognitive function in post-menopausal women |
| Study objectives | Cognitive function and mental health will improve following exercise intervention |
| Ethics approval(s) |
Approved 16/02/2023, Ethics Committee of the Faculty of Medicine, Airlangga University (Jl. Mayjen Prof. Dr. Moestopo No. 47, Surabaya, 60132, Indonesia; +62 (0)315020251; kepk@fk.unair.ac.id), ref: 44/EC/KEPK/FKUA/2023 |
| Health condition(s) or problem(s) studied | Cognitive function in post-menopausal women |
| Intervention | Participants will be recruited from women's organizations that participated in the Family Welfare Empowerment Program in Surabaya, East Java, Indonesia. The participants who met the inclusion criteria will be allocated to the exercise training group (EX group). Age-matched participants will be recruited from the neighborhood for the control group (CON group). The participants in the EX group will perform a 2-week exercise program that includes a combination of aerobic, strength, balance, and flexibility exercises. On the other hand, participants in the CON group will be asked to continue with their usual activities. |
| Intervention type | Behavioural |
| Primary outcome measure | Cognitive function: 1. Executive function measured using Stroop test 2. Global cognitive function measured using Mini Mental Health Examination (MMSE) All the outcomes will be measured before and after the exercise intervention in the EX group or before and at 2 weeks in the CON group |
| Secondary outcome measures | Mental health measured using the Depression, Anxiety and Stress Scale - 21 Items (DASS-21) questionnaire before and after the exercise intervention |
| Overall study start date | 07/11/2022 |
| Completion date | 27/04/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Lower age limit | 50 Years |
| Upper age limit | 80 Years |
| Sex | Female |
| Target number of participants | 28 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Women aged 50-80 years old who are at least 12 months postmenopausal 2. Minimum educational level of junior high school) 3. Did not have a history of stroke or any neurological problems, recent surgery, severe hearing or visual impairment, recent cardiovascular diseases (such as ischemic heart diseases and heart failure), mental health problems, dementia or moderate to severe cognitive impairment (defined as score of less than 21 on the MMSE |
| Key exclusion criteria | Have a musculoskeletal condition that impairs their ability to undertake exercise training |
| Date of first enrolment | 27/02/2023 |
| Date of final enrolment | 13/04/2023 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Jl. Mayjen Prof. Dr. Moestopo No. 47
Surabaya
60132
Indonesia
Sponsor information
Government
Kompleks Kementerian Pendidikan, Kebudayaan, Riset, dan Teknologi
Jalan Jenderal Sudirman, Senayan
Jakarta Pusat
Jakarta
10270
Indonesia
| Phone | +62 (0)2157946104 |
|---|---|
| dikti@kemdikbud.go.id | |
| Website | http://dikti.kemdikbud.go.id |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Kementerian Riset, Teknologi, dan Pendidikan Tinggi, Kementerian Riset Teknologi Dan Pendidikan Tinggi Republik Indonesia, Ministry of Research, Technology and Higher Education, Kementerian Ristek Dikti, Kementerian Riset dan Teknologi, Ministry of Research, Technology and Higher Education of the Republic of Indonesia
- Location
- Indonesia
Results and Publications
| Intention to publish date | 26/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal Added 13/02/2024: The researchers are in the revision process for a high-impact journal. |
| IPD sharing plan | De-identified datasets generated/analyzed during this study will be shared on request to Raden Argarini (raden-a@fk.unair.ac.id) and with a data use agreement. The data will be available until 02/12/2024. Consent from participants was required and obtained |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/08/2024 | 15/08/2024 | Yes | No |
Editorial Notes
15/08/2024: Publication reference added.
13/02/2024: The following changes were made to the study record:
1. Publication and dissemination plan updated.
2. The intention to publish date was changed from 26/02/2024 to 26/03/2024.
03/01/2024: Study's existence confirmed by the Ethics Committee of the Faculty of Medicine, Airlangga University.
