Comprehensive program to enhance the quality of life of elderly people in nursing homes
| ISRCTN | ISRCTN13989556 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13989556 |
- Submission date
- 23/05/2022
- Registration date
- 08/06/2022
- Last edited
- 31/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Measuring the quality of life of the elderly is an important issue in national development planning. This can be used as a reference to determine how much budget is going to be allocated to health services and social care. In addition, this also can be used as an indicator to assess the development of the physical and mental health of the elderly. Elderly people who live in nursing homes usually have a low quality of life than those who live in the community. This is due to the high number of some incidents such as high blood pressure, falls, anxiety, diabetes, dementia, depression, and the neglect which occurs in some aspects of elderly life such as the psychological, physical, financial, and sexual aspects. Several efforts have been done to improve the quality of life of the elderly. However, these activities are focused only on one aspect of some domains of quality of life. In addition to this, the majority of the programs are implemented in the community while programs in nursing homes are relatively few. The comprehensive intervention of this study, which includes physical, mental, and spiritual aspects, makes this study different from the previous studies on the same topic. The main aim of this study is to assess the effect of the comprehensive intervention (SPIRIT) on the quality of life of elderly people in nursing homes. The other variables such as physical fitness, anxiety, blood pressure, and risk of falls are several additional measurements that will also be obtained from this study.
Who can participate?
Elderly people aged 60 years and over who have lived in a nursing home for a minimum of 3 months
What does the study involve?
Participants involved in the intervention group will be asked to perform moderate-intensity physical activity including aerobic exercise, static cycling, or walking, which is done alternately, with additional activities such as flexibility, strength, balance, breathing relaxation, and gratitude. This intervention will take 50-60 minutes and will be performed three times a week for 16 weeks accompanied by an instructor (an undergraduate student of Faculty of Sport, University of Sebelas Maret, Surakarta, Indonesia). The control group will undergo routine activities which are usually done in nursing homes. Measurements will be taken for both groups at the start of the study and after 16 weeks.
What are the possible benefits and risks of participating?
Programs based on physical, mental, and spiritual activity have been widely reported to give benefits to the elderly. This kind of program can be used to prevent non-communicable diseases and depression, and to improve quality of life. This intervention program is compiled based on previous studies. Moreover, it has been examined and received approval from sports experts and psychologists from the University of Sebelas Maret. Therefore, it is feasible to be implemented for the elderly. To minimize the risk of injury, this program will be started according to ability, starting from 40% of the maximum target pulse rate, then it can be increased gradually every 2 weeks. The instructor will monitor the pulse by using pulse oximetry during exercise and will also give an opportunity to take a rest and drink enough water. The participants can also stop doing the program at any time they wish. Caregivers will observe the health condition of participants and will communicate to the researcher.
Where the study runs for
Nursing homes in Surakarta (Indonesia)
When is the study starting and how long is it expected to run?
July 2021 to October 2022.
Who is funding the study?
Institution of Research and Community Services, University of Sebelas Maret, Surakarta (Indonesia)
Who is the main contact?
Erindra Budi Cahyanto
erindrabudi@staff.uns.ac.id
Contact information
Public
Arjuna 1 street number 11 Serengan
Surakarta
57155
Indonesia
 ORCID ID |
0000-0002-3564-4397 |
|---|---|
| Phone | +62 (0)88802404967 |
| erindrabudi@staff.uns.ac.id |
Study information
| Study design | Double-blind cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | 41811_PIS.pdf |
| Scientific title | The effect of the SPIRIT program on the quality of life of elderly people in nursing homes |
| Study acronym | SPIRIT |
| Study objectives | 1. The SPIRIT program (physical exercise, static cycling, walking, respiratory relaxation, gratitude, blood pressure monitoring) is more effective at improving quality of life than the routine programs that are commonly undertaken by elderly people in nursing homes. 2. The SPIRIT program (physical exercise, static cycling, walking, respiratory relaxation, gratitude, blood pressure monitoring) is more effective at improving physical fitness than the routine programs that are commonly undertaken by elderly people in nursing homes 3. The SPIRIT program (physical exercise, static cycling, walking, respiratory relaxation, gratitude, blood pressure monitoring) is more effective at reducing anxiety than the routine programs that are commonly undertaken by elderly people in nursing homes 4. The SPIRIT program (physical exercise, static cycling, walking, respiratory relaxation, gratitude, blood pressure monitoring) is more effective at reducing blood pressure than the routine programs that commonly undertaken by elderly people in nursing homes 5. The SPIRIT program (physical exercise, static cycling, walking, respiratory relaxation, gratitude, blood pressure monitoring) is more effective at reducing the risk of falls than the routine programs that are commonly undertaken by elderly people in nursing homes |
| Ethics approval(s) | Approved 15/09/2021, Research Ethics Committee of Faculty of Medicine, University of Sebelas Maret (Gedung Pendidikan Dokter Baru, 2nd Floor, Faculty of Medicine, University of Sebelas Maret, Ir. Sutami Street 36 A, Surakarta , Jawa Tengah 57126, Indonesia; +62 (0)271 664178 Ext. 1125; kepk@fk.uns.ac.id), ref: 88/UN27.06.6.1/KEP/EC/2021 |
| Health condition(s) or problem(s) studied | Elderly people in good health |
| Intervention | Five nursing homes will be involved in this study. One nursing home will be assigned for a pilot study to identify the feasibility of the intervention and to measure variables. There are four nursing homes involved in the main study. The placement of respondents will be done by using cluster randomization. The cluster in this study is the nursing home. The placement of clusters to the intervention group or control group will be carried out online at http://bagikelompok.rf.gd/?i=1. Blinding is then performed. All participants involved in this study (administrator, data collector) do not know whether clusters are in the interventional group or the control group. SPIRIT is a program to improve the quality of life of the elderly in nursing homes which consists of varied moderate-intensity physical activities including aerobic exercise in the form of gymnastics, static cycling, or walking, which are carried out alternately, plus flexibility, strength, balance, and other activities. breathing relaxation, and gratitude, carried out three times a week for 16 weeks accompanied by an instructor (sports and psychology expert from Sebelas Maret University, Surakarta). The training procedure is as follows: 1. The exercise begins with a prayer together 2. A brief explanation from the instructor about the exercise 3. Physical exercise is done together in small groups 4. Warm-up movement for 5 minutes 5. Physical exercise, consisting of: 5.1. Aerobic exercise, including static cycling, walking, and elderly gymnastics, selected alternately. 5.1.1. Static bicycles: two 10-minute stationary cycles, with 3-minute breaks in the shade in a nursing home. 5.1.2. Walking: walking in place or walking at the usual pace in the courtyard of the nursing home complex for two periods of 10 minutes with 3 minutes of rest interspersed 5.1.3. Heart healthy elderly aerobic exercise. This gymnastics already includes aerobic, strength, balance, and flexibility exercises. 5.2. Strength training: eight repetitions of two sets, with 1-minute rest for each set. 5.3. Balance exercises: two types of balance exercises, interspersed with 1-minute rest. 5.4. Flexibility exercises: three-joint flexibility exercises, eight repetitions of two sets. 6. During the exercise, the instructor asks whether the subject had any complaints such as dizziness, chest pain, shortness of breath, or movement disorders during physical exercise. If there are complaints, physical exercise is stopped. The instructor also gave words of humor and encouragement in between physical exercises. 7. Measuring the pulse using a pulse oximeter in random subjects during exercise. 8. Cool down for 5 minutes 9. Give a chance to drink at rest 10. The instructor invites the subject to sit in the shade, and leads a breathing relaxation for 5 minutes. 11. The instructor guides gratitude therapy by showing inspiring pictures or short stories, or tangible evidence of God's gifts that have been bestowed, such as food, drink, oxygen, health, etc, followed by asking the subject to name the various gifts from God that have been bestowed and inquiring about the perceived impact (whether it is closer to what it is desired, and further away from what is being worried about). 12. The instructor provides reinforcement to increase the subject's self-confidence, efficacy, and self-esteem so that they follow the program the next day and carry out the SPIRIT program independently. 13. Closing prayer. Physical exercise equipment is provided by the researcher. Practice principle The SPIRIT program will be held for 16 weeks, three times a week, 50-60 minutes for each session in the morning. Physical exercise in the SPIRIT program starts according to the capability of the elderly for example 40% of the maximum pulse rate. For those participants who are fully capable to do the intervention, the program will be gradually increased in term of time, load, and will be repeated every 2 weeks until it reaches the level of recommended exercise by experts which is 150-300 minutes per week or 60-80% of the maximum pulse rate. Other exercises which include muscle strength, balance and flexibility exercises will be added one type of exercise every month. The exercises will be perfomed in a good emotional environment.Gratitude therapy will be started by mentioning at minimum of three gifts received from God. It is then gradually increased in number each week. Control group Subjects in the control group will perform normal activities as usual. Based on the data obtained by researcher, caregivers in the nursing homes allow elderly people to do their individual physical and spiritual activities independently. It is not frequent for elderly people to do activities together with others, sometimes in a week or on a certain occasion only. |
| Intervention type | Behavioural |
| Primary outcome measure | Quality of life measured by WHO QoL BREF Bahasa Indonesia version before the intervention and after 16 weeks |
| Secondary outcome measures | 1. Physical fitness measured using 2-minute step test at baseline and 16 weeks 2. Anxiety measured using the Beck Anxiety Inventory at baseline and 16 weeks 3. Ambulatory blood pressure measured using an automatic arm style electronic blood pressure monitor at baseline and 16 weeks 4. Risk of fall measured using the Berg Balance Scale Test at baseline and 16 weeks |
| Overall study start date | 01/07/2021 |
| Completion date | 30/10/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 52 |
| Key inclusion criteria | 1. ≥60 years old 2. Able to communicate 3. Willing to undergo the intervention of this study 4. Has lived in nursing homes for a minimum of 3 months 5. Has scored A on the Katz index of activities of daily living 6. Receive permission from the Director of the nursing home |
| Key exclusion criteria | 1. Chronic diseases which cause participants not to be able to participate in the SPIRIT program 2. Vision and hearing impairment 3. Blood pressure >180/100 mmHg 4. Oxygen saturation level <95% |
| Date of first enrolment | 10/06/2022 |
| Date of final enrolment | 20/06/2022 |
Locations
Countries of recruitment
- Indonesia
Study participating centres
Surakarta
57138
Indonesia
Surakarta
57146
Indonesia
Surakarta
57136
Indonesia
Surakarta
57127
Indonesia
Sponsor information
University/education
Gedung Pendidikan Dokter, Medicine Faculty, UNS 7th Floor
Ir. Sutami street number 36 A Kentingan
Surakarta
57126
Indonesia
| Phone | +62 (0)271 664178 |
|---|---|
| s3ikm@pasca.uns.ac.id | |
| Website | https://pasca.uns.ac.id/s3ikm/ |
"ROR" |
https://ror.org/021hq5q33 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Sebelas Maret University, UNS
- Location
- Indonesia
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 06/06/2022 | No | Yes | ||
| Basic results | 31/10/2023 | No | No |
Additional files
Editorial Notes
31/10/2023: Basic results summary added.
08/09/2023: The intention to publish was changed from 01/03/2023 to 31/12/2023.
06/06/2022: Trial's existence confirmed by the Sebelas Maret University.
