- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05373368
Quality of Life Related to Activities of Elderly Individuals Living at Home or Nursing Homes
How Quality of Life of Elderly Individuals Living at Home or in Nursing Homes is Related to Multi Purpose Activities?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this study, investigators performed multi-purpose activity programs to see the effects on the quality of life (QOL) of the older persons. Eighty-one participants aged >60 residing in Ankara volunteered to participate in: 45 at the a nursing home, and 36 living in their own homes in the town. The investigators received participants' information from their files or from relatives to verify their eligibility criteria for this randomized study. The ethical review committee of Hacettepe University approved the study and written informed consent was obtained from each participant. This study was performed in accordance with the Declaration of Helsinki.
The collected socio-demographic data included age, gender, co-morbidities, years of schooling completed, and marital status. The 36-item Short Form Health Survey (SF 36) was used prior to and following the program in order to evaluate participants' QOL. Its eight parameters cover general health, physical functioning, vitality, physical role, physical energy level, social functioning, emotional role, and mental health. Higher scores indicate better functioning.
A therapist led the activity programs according to participants' requests and needs. Over twice-weekly 45-minute sessions for a period of 12 weeks, participants performed chosen activities in a group from the following three categories:
- Handicrafts: ornament design, painting on cloth or glass, knitting, lace making, constructing book braces or vase base plates, arts, or woodwork.
- Physical activities: gardening or dance.
- Cognitive activities: puzzles (jigsaw and crossword), table games (backgammon and chess), watching classic movies, reading books, writing in diaries, or reminiscence activities.
The "General Health" sub-parameter of SF-36 was chosen to calculate the change between groups to determine the sample size, since this is theoretically the item with the widest range in mean and standard deviation. In the literature, the least level for measuring significant intra-group differences prior to and following a study intervention was 5 ± 8 points. With this information, investigators determined a sample size of 30 individuals per group was needed in order to have the correct power and confidence levels (90% and 95%, respectively) to detect a statistically significant difference using a 0.05 cut-off . Statistical analysis was performed using SPSS for Windows v. 23. Descriptive data were presented as mean (X) ± standard deviation (SD). Categorical data were presented as counts and percentages. The independent t-test was used to compare the QOL of at-home residents with those in the nursing home, and the Mann-Whitney U test was used if the parametric test assumptions are not ensured. A dependent t-test was used to analyze results prior to and following the activities program, and the Wilcoxon test was used when the parametric test assumptions were not ensured. P values <0.05 were considered to be statistically significant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- aged over 60 years and above
- individuals without physical, mental, or sensory integration disabilities that might interfere with their performance in activities
Exclusion Criteria:
- being un-volunteered
- aged below 60 years
- having comorbidities that interfere with activities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: home residents
multi purpose activities were performed for home residents
|
|
|
Experimental: nursing home residents
multi purpose activities were performed for nursing home residents
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
improved quality of life caused by participation in activities
Time Frame: 45 minutes
|
Changes on the prior scores of quality of life assessed by SF-36, of the elderly at 12 weeks
|
45 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hulya Yucel, Assoc. Prof., Saglik Bilimleri University
Publications and helpful links
Helpful Links
- Effects of Recreational Exercises on the Strength, Flexibility, and Balance of Old-old Elderly Individuals
- The effects of physical activity on anxiety, depression, and quality of life in elderly people living in the community
- A study of physical activity, frailty, and health related quality of life among community-dwelling older adults in Taiwan
- Effects of a group-based physical and cognitive intervention on social activity and quality of life for elderly people with dementia in a geriatric health service facility: a quasi-randomised controlled trial.
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
Keywords
Other Study ID Numbers
- 07.T09.102.001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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