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.
