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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05373368
Other study ID # 07.T09.102.001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2016
Est. completion date September 15, 2018

Study information

Verified date May 2022
Source Saglik Bilimleri Universitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

For older persons, successful aging generally involves staying active and maintaining social interactions. Active aging involves more engagement in enjoyable activities. The hypothesis of this study was to determine the effects of multi-purpose activities on the quality of life of elderly individuals living either in a nursing home or in their own homes. Sixty-seven volunteers aged >60 were surveyed: 34 living in a nursing home and 33 living at-home. Participants performed activities consisting of physical, cognitive tasks, and handicrafts twice weekly for 12 weeks. Each participant completed the 36-item Short Form Health Survey both before and after the program, and the results were compared between the groups.


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: 1. Handicrafts: ornament design, painting on cloth or glass, knitting, lace making, constructing book braces or vase base plates, arts, or woodwork. 2. Physical activities: gardening or dance. 3. 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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date September 15, 2018
Est. primary completion date April 15, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
multi purpose activities


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi

Outcome

Type Measure Description Time frame Safety issue
Primary improved quality of life caused by participation in activities Changes on the prior scores of quality of life assessed by SF-36, of the elderly at 12 weeks 45 minutes
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