ElderlyNCT05373368
Quality of Life Related to Activities of Elderly Individuals Living at Home or Nursing Homes
A study testing multi purpose activities in people with Elderly and Quality of Life, run by Saglik Bilimleri Universitesi.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly, Quality of Life, Physical Activity
- What is being tested?
- multi purpose activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2016to 15 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged over 60 years and above
- individuals without physical, mental, or sensory integration disabilities that might interfere with their performance in activities
Who cannot join
- being un-volunteered
- aged below 60 years
- having comorbidities that interfere with activities
About this study
Official title: How Quality of Life of Elderly Individuals Living at Home or in Nursing Homes is Related to Multi Purpose Activities?
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.
Read the 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.
- Conditions
- Elderly, Quality of Life, Physical Activity
- Being tested
- multi purpose activities
- Keywords
- Elderly, Leisure activity, Quality of life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi purpose activitiesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| home residents | Experimental | multi purpose activities were performed for home residents Receives: Behavioral: multi purpose activities |
| nursing home residents | Experimental | multi purpose activities were performed for nursing home residents Receives: Behavioral: multi purpose activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start15 Jan 2016
- Primary completion15 Apr 2016
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hulya Yucel, Saglik Bilimleri Universitesi
- Investigators
- Hulya Yucel, Assoc. Prof., Principal investigator, Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373368
- Sponsor's protocol ID
- 07.T09.102.001
- Status last verified
- May 2022
- First submitted
- 8 May 2022
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Quality of Life of Elderly Individuals Living at Home or in Nursing Homes is Related to Multi Purpose Activities?
- ClinicalTrials.gov ID
- NCT05373368
- Acronym / sponsor ID
- 07.T09.102.001
- Conditions
- Elderly, Quality of Life, Physical Activity
- Keywords
- Elderly, Leisure activity, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 15 Apr 2016 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| home residents | Experimental | Behavioral: multi purpose activitiesmulti purpose activities were performed for home residents |
| nursing home residents | Experimental | Behavioral: multi purpose activitiesmulti purpose activities were performed for nursing home residents |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged over 60 years and above
- individuals without physical, mental, or sensory integration disabilities that might interfere with their performance in activities
Key exclusion criteria (3 listed)
- being un-volunteered
- aged below 60 years
- having comorbidities that interfere with activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi purpose activities | Behavioural | home residents, nursing home residents |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Effects of Recreational Exercises on the Strength, Flexibility, and Balance of Old-old Elderly IndividualsLink provided by the sponsor.
- The effects of physical activity on anxiety, depression, and quality of life in elderly people living in the communityLink provided by the sponsor.
- A study of physical activity, frailty, and health related quality of life among community-dwelling older adults in TaiwanLink provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hulya Yucel, Assoc. Prof. principal investigator
Saglik Bilimleri University
Questions about this trial
What is this clinical trial studying?
A study testing multi purpose activities in people with Elderly and Quality of Life, run by Saglik Bilimleri Universitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improved quality of life caused by participation in activities (time frame: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.