- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06849427
Effects of Multicomponent Exercise on Quality of Life, Coping With Stress, and Well-Being in Older Women
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;
- 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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Antalya, Turkey
- Antalya Aktif Yaşlı Merkezi
-
-
Antalya
-
Konyaaltı, Antalya, Turkey
- Antalya Aktif Yaşlı Merkezi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being literate
- Being a woman over 60
- Agreeing to participate in the research
- Being able to speak and understand Turkish
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise group
Multi-component exercise application will be performed
|
Multicomponent Exercise Program A. Flexibility B. Targeted Strength Training C. Balance and Mobility
|
|
No Intervention: Control group
Multi-component exercise will not be applied
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
pre-intervention and immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress Coping Style Scale
Time Frame: pre-intervention and immediately after the intervention
|
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
|
pre-intervention and immediately after the intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Well-Being Scale
Time Frame: pre-intervention and immediately after the intervention
|
The Turkish adaptation of the Well-Being Scale, developed by Diener et al. (2009), was conducted by Fidan and Usta.
The scale has a 7-point Likert structure.
The highest score that can be obtained from the scale is 56, and the lowest score is 8.
There are no reverse-scored items in the scale.
High scores obtained from the scale indicate that the relevant individual has a high level of well-being.
It was conducted by Fidan and Usta (2013) on a total of 385 high school 4th grade students, 166 (%43) girls and 219 (%57) boys.
The Cronbach alpha internal consistency coefficient of the Well-Being Scale was found to be .83.
|
pre-intervention and immediately after the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
- Ko 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.
- Varela 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Study Data/Documents
-
Individual Participant Data Set
Information identifier: sibelcynk@gmail.comInformation comments: If online access is not available: instructions for how to obtain information
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Ziekenhuis Oost-LimburgRecruitingQuality of Life | Postoperative Quality of Recovery | Health-Related Quality-of-LifeBelgium
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Istituto Ortopedico RizzoliUniversity of BolognaCompletedImprove Quality of LifeItaly
-
Children's National Research InstituteCompletedProfessional Quality of LifeUnited States
-
Region VästmanlandUnknownHealth Related Quality of Life
-
Ain Shams UniversityCompletedHealth Related Quality of LifeEgypt
-
Institute of Oncology LjubljanaUnknownHealth-related Quality of LifeSlovenia
-
Oslo University HospitalNorwegian Fund for Postgraduate Training in PhysiotherapyCompletedHealth-Related Quality of LifeNorway
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
Clinical Trials on multicomponent exercise intervention
-
Fundacion Miguel ServetUniversidad Pública de Navarra; Complejo Hospitalario de NavarraCompletedFrailty | Disability Physical | Hospital Acquired ConditionSpain
-
University of the Basque Country (UPV/EHU)Completed
-
Foundation University IslamabadCompletedPeripheral Diabetic NeuropathyPakistan
-
Montreal Heart InstituteCompletedNeurodegenerative Diseases | Primary Progressive Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Non-fluent AphasiaCanada
-
Federal University of PelotasRecruitingBreast Cancer FemaleBrazil
-
Complejo Hospitalario Universitario de AlbaceteRecruiting
-
National University Hospital, SingaporeNational Medical Research Council (NMRC), SingaporeUnknownFrail Elderly Syndrome
-
Federal University of Rio Grande do SulRecruiting
-
Fundacion Miguel ServetCompletedCancer | Aging | Hospital Acquired Condition | DebilitySpain
-
Instituto Politécnico de BragançaCompleted