Quality of LifeNCT06849427
Effects of Multicomponent Exercise on Quality of Life, Coping With Stress, and Well-Being in Older Women
A study testing multicomponent exercise intervention in people with Quality of Life and Coping, run by Antalya Bilim University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of multi-component exercise on quality of life, coping with stress and well-being in elderly women. The objectives of the study are; To determine the contribution of multi-component exercise to active and healthy aging in elderly women To present the effects of… Read more about this study
- Who is it for?
- Ages 60 to 85 years, women only
- Conditions the study is for
- Quality of Life, Coping, Well-being
- What is being tested?
- multicomponent exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Mar 2025to 28 May 2025
- 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 60 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being literate
- Being a woman over 60
- Agreeing to participate in the research
- Being able to speak and understand Turkish
Who cannot join
- Those who have previously engaged in active regular exercise and continue to do so
- Those who are unable to do physical exercise due to any illness
- Those who are involved in another study simultaneously with this study outside of routine practices
- Those who have another neurological or psychiatric diagnosis affecting their cognitive status
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Antalya Aktif Yaşlı Merkezi
Antalya
Antalya Aktif Yaşlı Merkezi
Konyaalti, Antalya
About this study
Official title: Effects of Multicomponent Exercise on Quality of Life, Coping With Stress, and Well-Being in Older Women: A Randomized Controlled Trial
The aim of this study is to evaluate the effects of multi-component exercise on quality of life, coping with stress and well-being in elderly women.
The objectives of the study are;
Read more
- To determine the contribution of multi-component exercise to active and healthy aging in elderly women
- To present the effects of multi-component exercise on quality of life, coping with stress and well-being in elderly women and to create data to guide practitioners for nursing care practices.
This study will determine whether multi-component exercise will make a positive contribution to quality of life, well-being and coping strategies in elderly women and will contribute to the deepening of existing knowledge on the effects of multi-component exercise on health.
Read the detailed description
Aging is a natural and inevitable process of change that begins in the fetal period and continues until death in all living things. Old age refers to a period in which many people experience feelings of loss, lose their physical, functional, psychological and social independence and increase their dependency. The World Health Organization (WHO) accepts the age limit as 65 years and above, while the United Nations accepts it as 60 years and above. In parallel with the developments in technology, science and health, 9.3% of the world's population and 9.1% in our country constitute the elderly population. 61% of the population aged 80 and above in the world are women, and the female/male ratio in this population is increasing day by day.
Biological differences cause women to spend more than a third of their lives in old age and to have more health-seeking behaviors due to men's higher rates of smoking, alcohol and substance use. This situation causes older women to experience chronic diseases, violence, abuse and reproductive health problems, psychological and mental problems, care and housing problems longer than older men. According to the study of Ko et al. (2019), it was found that women have lower socioeconomic and health status than men, and their health status and social service needs are higher than men. In addition, studies have shown that urinary incontinence, osteoporosis, vision, hearing problems, cardiovascular diseases such as hypertension, which are common in elderly women, negatively affect their mobility and quality of life.
The care that should be given to the elderly should be multifaceted, and in addition to physical and medical aspects, social and psychological aspects should not be neglected. Functional losses and social losses that occur in old age naturally affect women more. Coping with stress is defined as a series of cognitive and behavioral efforts aimed at managing special needs that exceed the individual's internal resources. Although the life behaviors developed by women to cope with stress in the literature vary from culture to culture, most studies have focused on education, physical activity/exercise, healthy nutrition, stress management, developing healthy behaviors, and preventing diseases and osteoporosis. Some problems such as increasing health problems in old age, loss of professional and social status, loss of function, and increased dependence on others deteriorate the quality of life and negatively affect well-being. Although wellness is simply defined as a process, a lifestyle, it consists of multifaceted sub-dimensions such as social, physical, and spiritual well-being. In geriatric studies aimed at maintaining well-being, studies are carried out on social activities, psychological support, and exercise, nutrition, and the ability of the individual to continue their daily activities independently. In the study of Östh et al. (2019), it is reported that yoga is effective in improving well-being, mobility, mood and cognition, and that yoga can be added to the exercise program of the elderly. In addition, in the study of Sorusa et al., it was determined that yoga applied during the climacteric period positively affects the quality of life and well-being.
Current geriatric studies target active aging and report that exercise is necessary for a healthy aging process. While exercising increases muscle mass, muscle strength, balance and speed, it also helps elderly individuals increase their independence and reduce functional disability. WHO's exercise recommendations for elderly individuals include both strength exercises and balance exercises to reduce the risk of falls, as well as aerobic exercises. The recommendation for older adults is 150 minutes of moderate-intensity exercise per week, and it is stated that it is more appropriate to divide this time into certain days of the week. Epidemiological studies have shown that people with high levels of physical activity have lower levels of depression and anxiety. On the other hand, high levels of habitual physical activity are associated with a reduced risk of cognitive decline, dementia, and Alzheimer's disease in later life. Physical exercise improves memory function in older people with mild cognitive impairment.
- Conditions
- Quality of Life, Coping, Well-being, Older People, Woman's Health, Exercise
- Being tested
- multicomponent exercise intervention
- Keywords
- quality of life, coping, well being, older people, exercise, women's health
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multicomponent exercise interventionOther
Multicomponent Exercise Program
- Flexibility B. Targeted Strength Training C. Balance and Mobility
- Center of Gravity Control Training
- Multisensory Training
- Postural Strategy Training
- Gait Pattern Development Variation Training
- Dual Task Exercises . D. Cardiovespiratory Fitness
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Multi-component exercise application will be performed Receives: Other: multicomponent exercise intervention |
| Control group | No intervention | Multi-component exercise will not be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of Life Assesment
The World Health Organization Quality of Life Scale Short Form is a 26-question shortened version of the 100-question World Health Organization Quality of Life Assesment (WHOQOL) scale, which was prepared to assess how an individual perceives their quality of life. The scale, which includes closed-ended questions, consists of four sub-domains: physical, social, environmental, and psychological. The physical domain consists of questions 3, 4, 10, 15, 16, 17, and 18; the psychological domain consists of questions 5, 6, 7, 11, 19, and 26; the social domain consists of questions 20, 21, 22; and the environmental domain consists of questions 8, 9, 12, 13, 14, 23, 24, and 25. The scale does not have a full score, and an increase in score indicates an improvement in quality of life. The Turkish validity and reliability study of the scale was conducted by Eser and his colleagues in 1999, and during their work, a national question was added to the scale, increasing the number of questions to 2
Measured: pre-intervention and immediately after the intervention
Secondary outcomes (1)
Stress Coping Style Scale
The scale, developed by Folkman and Lazarus in 1988, was adapted to Turkish by Şahin and Durak in 1995 and its validity and reliability studies were conducted. Later, Şahin and Durak (1995) adapted the Ways of Coping with Stress Scale for university students. The scale consists of 30 items and is a 4-point Likert type (0=not at all appropriate, 1=not appropriate, 2=appropriate, 3=completely appropriate). Only items 1 and 9 are scored in reverse. The scale, which has two dimensions, consists of five subsections. The first of its dimensions is aimed at effectively solving the encountered problem and is called "Problem-oriented/active" and consists of the subsections "Applying to social support", "Optimistic approach" and "Self-confident approach". The other dimension is related to emotional coping, which is considered as ineffective coping, and is called "Emotion-oriented/passive" and consists of the subsections "Helpless approach" and "Submissive approach". Individuals who can effectiv
Measured: pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start3 Mar 2025
- Primary completion3 Mar 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 20 experimental, 20 control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Bilim University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849427
- Sponsor's protocol ID
- 2025-002
- Status last verified
- Feb 2025
- First submitted
- 14 Jan 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants' demographic data and scale scores will be shared with other researchers.
Publications
Muchiri WA, Olutende OM, Kweyu IW, Vurigwa E. Meaning of Physical Activities for the Elderly: A Review. Am J Sports Sci Med 2018;6:79-83. https://www.researchgate.net/publication/327602163_Meaning_of_Physical_Activities_for_the_Elderly_A_Review
Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 2017 Jul 20. No abstract available.
PubMed 28735855Ko KY, Kwok ZCM, Chan HY. Effects of yoga on physical and psychological health among community-dwelling older adults: A systematic review and meta-analysis. Int J Older People Nurs. 2023 Sep;18(5):e12562. doi: 10.1111/opn.12562. Epub 2023 Aug 14.
PubMed 37577926Varela S, Ayan C, Cancela JM, Martin V. Effects of two different intensities of aerobic exercise on elderly people with mild cognitive impairment: a randomized pilot study. Clin Rehabil. 2012 May;26(5):442-50. doi: 10.1177/0269215511425835. Epub 2011 Nov 24.
PubMed 22116953Caynak S, Boyacioglu NE, Oruc M, Yakisan E. Effects of multicomponent exercise on quality of life, coping with stress, and psychological well-being in aged women: a randomized controlled trial. BMC Geriatr. 2026 Mar 11;26(1):543. doi: 10.1186/s12877-026-07166-7.
PubMed 41808081
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multicomponent Exercise on Quality of Life, Coping With Stress, and Well-Being in Older Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06849427
- Acronym / sponsor ID
- 2025-002
- Conditions
- Quality of Life, Coping, Well-being, Older People, Woman's Health, Exercise
- Keywords
- quality of life, coping, well being, older people, exercise, women's health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Antalya Bilim UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 27 Feb 2025 (actual)
- 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.
The aim of this study is to evaluate the effects of multi-component exercise on quality of life, coping with stress and well-being in elderly women.
The objectives of the study are;
- To determine the contribution of multi-component exercise to active and healthy aging in elderly women
- To present the effects of multi-component exercise on quality of life, coping with stress and well-being in elderly women and to create data to guide practitioners for nursing care practices.
This study will determine whether multi-component exercise will make a positive contribution to quality of life, well-being and coping strategies in elderly women and will contribute to the deepening of existing knowledge on the effects of multi-component exercise on health.
Detailed description
Aging is a natural and inevitable process of change that begins in the fetal period and continues until death in all living things. Old age refers to a period in which many people experience feelings of loss, lose their physical, functional, psychological and social independence and increase their dependency. The World Health Organization (WHO) accepts the age limit as 65 years and above, while the United Nations accepts it as 60 years and above. In parallel with the developments in technology, science and health, 9.3% of the world's population and 9.1% in our country constitute the elderly population. 61% of the population aged 80 and above in the world are women, and the female/male ratio in this population is increasing day by day.
Biological differences cause women to spend more than a third of their lives in old age and to have more health-seeking behaviors due to men's higher rates of smoking, alcohol and substance use. This situation causes older women to experience chronic diseases, violence, abuse and reproductive health problems, psychological and mental problems, care and housing problems longer than older men. According to the study of Ko et al. (2019), it was found that women have lower socioeconomic and health status than men, and their health status and social service needs are higher than men. In addition, studies have shown that urinary incontinence, osteoporosis, vision, hearing problems, cardiovascular diseases such as hypertension, which are common in elderly women, negatively affect their mobility and quality of life.
The care that should be given to the elderly should be multifaceted, and in addition to physical and medical aspects, social and psychological aspects should not be neglected. Functional losses and social losses that occur in old age naturally affect women more. Coping with stress is defined as a series of cognitive and behavioral efforts aimed at managing special needs that exceed the individual's internal resources. Although the life behaviors developed by women to cope with stress in the literature vary from culture to culture, most studies have focused on education, physical activity/exercise, healthy nutrition, stress management, developing healthy behaviors, and preventing diseases and osteoporosis. Some problems such as increasing health problems in old age, loss of professional and social status, loss of function, and increased dependence on others deteriorate the quality of life and negatively affect well-being. Although wellness is simply defined as a process, a lifestyle, it consists of multifaceted sub-dimensions such as social, physical, and spiritual well-being. In geriatric studies aimed at maintaining well-being, studies are carried out on social activities, psychological support, and exercise, nutrition, and the ability of the individual to continue their daily activities independently. In the study of Östh et al. (2019), it is reported that yoga is effective in improving well-being, mobility, mood and cognition, and that yoga can be added to the exercise program of the elderly. In addition, in the study of Sorusa et al., it was determined that yoga applied during the climacteric period positively affects the quality of life and well-being.
Current geriatric studies target active aging and report that exercise is necessary for a healthy aging process. While exercising increases muscle mass, muscle strength, balance and speed, it also helps elderly individuals increase their independence and reduce functional disability. WHO's exercise recommendations for elderly individuals include both strength exercises and balance exercises to reduce the risk of falls, as well as aerobic exercises. The recommendation for older adults is 150 minutes of moderate-intensity exercise per week, and it is stated that it is more appropriate to divide this time into certain days of the week. Epidemiological studies have shown that people with high levels of physical activity have lower levels of depression and anxiety. On the other hand, high levels of habitual physical activity are associated with a reduced risk of cognitive decline, dementia, and Alzheimer's disease in later life. Physical exercise improves memory function in older people with mild cognitive impairment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 20 experimental, 20 control
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: multicomponent exercise interventionMulti-component exercise application will be performed |
| Control group | No intervention | –Multi-component exercise will not be applied |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being literate
- Being a woman over 60
- Agreeing to participate in the research
- Being able to speak and understand Turkish
Key exclusion criteria (4 listed)
- Those who have previously engaged in active regular exercise and continue to do so
- Those who are unable to do physical exercise due to any illness
- Those who are involved in another study simultaneously with this study outside of routine practices
- Those who have another neurological or psychiatric diagnosis affecting their cognitive status
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 |
|---|---|---|
| multicomponent exercise interventionMulticomponent Exercise Program A. Flexibility B. Targeted Strength Training C. Balance and Mobility 1. Center of Gravity Control Training 2. Multisensory Training 3. Postural Strategy Training 4. Gait Pattern Development Variation Training 5. Dual Task Exercises . D. Cardiovespiratory Fitness | Other | Exercise group |
Primary outcome
World Health Organization Quality of Life Assesment
Time frame: pre-intervention and immediately after the intervention
The World Health Organization Quality of Life Scale Short Form is a 26-question shortened version of the 100-question World Health Organization Quality of Life Assesment (WHOQOL) scale, which was prepared to assess how an individual perceives their quality of life. The scale, which includes closed-ended questions, consists of four sub-domains: physical, social, environmental, and psychological. The physical domain consists of questions 3, 4, 10, 15, 16, 17, and 18; the psychological domain consists of questions 5, 6, 7, 11, 19, and 26; the social domain consists of questions 20, 21, 22; and the environmental domain consists of questions 8, 9, 12, 13, 14, 23, 24, and 25. The scale does not have a full score, and an increase in score indicates an improvement in quality of life. The Turkish validity and reliability study of the scale was conducted by Eser and his colleagues in 1999, and during their work, a national question was added to the scale, increasing the number of questions to 2
1 secondary outcome
Stress Coping Style Scale
Time frame: pre-intervention and immediately after the intervention
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 29 Jul 2025.
- Results publicationMuchiri WA, Olutende OM, Kweyu IW, Vurigwa E. Meaning of Physical Activities for the Elderly: A Review. Am J Sports Sci Med 2018;6:79-83. https://www.researchgate.net/publication/327602163_Meaning_of_Physical_Activities_for_the_Elderly_A_Review
- Results publication: PubMed 28735855Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 2017 Jul 20. No abstract available.
- Results publication: PubMed 37577926Ko KY, Kwok ZCM, Chan HY. Effects of yoga on physical and psychological health among community-dwelling older adults: A systematic review and meta-analysis. Int J Older People Nurs. 2023 Sep;18(5):e12562. doi: 10.1111/opn.12562. Epub 2023 Aug 14.
- Results publication: PubMed 22116953Varela S, Ayan C, Cancela JM, Martin V. Effects of two different intensities of aerobic exercise on elderly people with mild cognitive impairment: a randomized pilot study. Clin Rehabil. 2012 May;26(5):442-50. doi: 10.1177/0269215511425835. Epub 2011 Nov 24.
- Derived from this study: PubMed 41808081Caynak S, Boyacioglu NE, Oruc M, Yakisan E. Effects of multicomponent exercise on quality of life, coping with stress, and psychological well-being in aged women: a randomized controlled trial. BMC Geriatr. 2026 Mar 11;26(1):543. doi: 10.1186/s12877-026-07166-7.
- Effects of two different intensities of aerobic exercise on elderly people with mild cognitive impairment: a randomized pilot studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participants' demographic data and scale scores will be shared with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multicomponent exercise intervention in people with Quality of Life and Coping, run by Antalya Bilim University at 2 sites in Turkey (Türkiye).
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 4 inclusion and 4 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 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
World Health Organization Quality of Life Assesment (time frame: pre-intervention and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06849427, which also lists 5 linked publications.
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 29 Jul 2025.