NCT06849427

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable quality-of-life

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

March 3, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
Last Updated

July 29, 2025

Status Verified

February 1, 2025

Enrollment Period

Same day

First QC Date

January 14, 2025

Last Update Submit

July 24, 2025

Conditions

Keywords

quality of lifecopingwell beingolder peopleexercisewomen's health

Outcome Measures

Primary Outcomes (1)

  • 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

    pre-intervention and immediately after the intervention

Secondary Outcomes (1)

  • Stress Coping Style Scale

    pre-intervention and immediately after the intervention

Other Outcomes (1)

  • Well-Being Scale

    pre-intervention and immediately after the intervention

Study Arms (2)

Exercise group

EXPERIMENTAL

Multi-component exercise application will be performed

Other: multicomponent exercise intervention

Control group

NO INTERVENTION

Multi-component exercise will not be applied

Interventions

Multicomponent 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

Exercise group

Eligibility Criteria

Age60 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being literate
  • Being a woman over 60
  • Agreeing to participate in the research
  • Being able to speak and understand Turkish

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Antalya Aktif Yaşlı Merkezi

Konyaalti, Antalya, Turkey (Türkiye)

Location

Antalya Aktif Yaşlı Merkezi

Antalya, Turkey (Türkiye)

Location

Related Publications (4)

  • 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

    RESULT
  • 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.

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
20 control
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 20 experimental, 20 control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2025

First Posted

February 27, 2025

Study Start

March 3, 2025

Primary Completion

March 3, 2025

Study Completion

May 28, 2025

Last Updated

July 29, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Participants' demographic data and scale scores will be shared with other researchers.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
February 2025-February 2026
Access Criteria
The data obtained in the study will be analyzed using the free trial version of SPSS Statistics (Statistical Package for Social Sciences) for Windows 25.0 program. Descriptive statistics (number, percentage, mean, standard deviation) will be used when evaluating the data. The normality test will be decided according to the significance value of the "Shapiro-Wilk" test. As a result of the normality test, the "Mann-Whitney U test" will be used for analyzes related to scales that do not show normal distribution, and the "Wilcoxon W" test will be used to analyze pre-test-post-test mean scores. In analyzes related to scales that show normal distribution, the "Independent Samples t test" and the "Paired Samples t test" will be used to analyze pre-test-post-test mean scores. "Reliability Analysis" will be performed in calculating the "Cronbach alpha" coefficients of the scales. In the study, p values under 0.05 will be considered significant.

Available IPD Datasets

Individual Participant Data Set (sibelcynk@gmail.com)Access

Locations