Older PeopleNCT04148196
The Effect of Progressive Relaxation Exercise on Adaptation to Old Age and Quality of Life.
A study testing Progressive muscle relaxation exercise in people with Older People, run by Aksaray University Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
The changes and limitations that occur in the aging process effect people's adaptation toold age. The quality of life of elderly individuals who have problems in adaptation to aging is negatively affected. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Older People
- What is being tested?
- Progressive muscle relaxation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 13 May 2019to 25 Nov 2019
- 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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years and above,
- Do not have a diagnosis of dementia and psychiatric disease by the doctor and have a mini-mental test score of 23 and above,
- There is no problem with communication
Who cannot join
- Having severe hearing or perceptual deficits that impaired communication
- Having dementia, Alzheimer's disease,
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Aksaray University Health Science Faculty
Aksaray, 68100
Cemile KÜTMEÇ YILMAZ
Merkez, Aksaray, 68100
About this study
Official title: Effect of Progressive Muscle Relaxation on Adaptation to Old Age and Quality of Life Among Older People in a Nursing Home: A Randomized Controlled Trial
The changes and limitations that occur in the aging process effect people's adaptation toold age. The quality of life of elderly individuals who have problems in adaptation to aging is negatively affected. This study aimed to assess the effect of effects of Progressive Muscle Relaxation on the adaptation levels and quality of life of the elderly living in nursing homes.
Read the detailed description
Today, changes and developments in technology and lifestyles have lengthened average life span and increased the elderly population. The physical and cognitive changes, health problems, new roles such asbeing retired or widowed and economic losses come one after anotherfor the elderly, and this turns the old age into a period full of difficul-ties. The difficulties experienced in this period introduce problems re-lated to the adaptation of the elderly to old age. The union of the problems arising due to old age decreases the self-respect and life satisfaction of the elderly individual, and consequently, the quality of life can be negatively affected.
Adaptation is defined as the harmony built by an individual between his own needs and the expectations of the people around.It is important for people to adapt to ever-changing life events sothat they can lead happy lives.The first condition of a healthy and problem-free old age is to accept and adapt to old age.Therefore, the purposes of nursing care cover ensuring an individual's adaptation toold age and its changes, which is the last development phase of life.
Nurses can positively change people's adaptation to old age by applying simple andeconomic non-pharmacological methods that are easy to apply. The non-pharmacological methods used in this study for older people'sw included progressive muscle relaxation exercise. It is stated in the literature that progressive relaxation exercise increases the quality of life and satisfaction of elderly individuals. However, there was no study thatassessed the effect of progressive muscle relaxation exercise on adaptation to old age.
Objective: Evaluate the effects of progressive muscle relaxation on the adaptation levels older people's and quality of life of the elderly living in nursing homes.
Methodology: This is randomized clinical test. The sample was made up of 45 older people living in nursing homes (24 in control group and 21 in the experimental group). The progressive muscle relaxation technique was employed. In order to collect the data, we adopted the interview with form filling technique, using the introductory information form, Assessment Scale of Adaptation Difficulty for the Elderly (ASADE) and Nottingham Health Profile (NHP)". Blood pressure and heart rate of experimental group were measured before and after the progressive muscle relaxation intervention.
- Conditions
- Older People
- Being tested
- Progressive muscle relaxation exercise
- Keywords
- Older people, Adaptation, Life quality, Nursing home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive muscle relaxation exerciseOther
The CD on relaxation exercises developed by the Turkish Psy-chological Associationwas used.In the second of CD 27-min section; relaxation exercises are explained to the accompaniment ofrunning water sounds and verbal instructions. Progressive relaxation technique includes stretching and relaxing the bigmuscle groups (hands, arms, neck, shoulders, face, chest, abdomen,hip, feet andfingers) in the human body on purpose. When steps ofProgressive Relaxation Exercises are analyzed, it is observed thatlearning how to take correct and deep breaths is the most impor-tant step towards learning relaxation. In addition, taking correct breaths is used as a part of the exercise among all relaxation exercises.Steps of Progressive Relaxation Exercise:- breathing exercises- lower extremity exercises- upper extremity exercises- exercise of respiratory muscles. Elderly individuals will receive PMR exercise twice a week under the guidance of an investigator for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | older people's who have a Standard Mini Mental Test score of 23 and above, living in nursing homes. |
| Experimental group | Experimental | Intervention group: older people's who have a Standard Mini Mental Test score of 23 and above, living in nursing homes.The researcher will perform 16 sessions of progressive relaxation exercises twice a week for 8 weeks. Each PMR exercise was conducted under the guidance of the researcher. Before and after each session of the Progressive Muscle Relaxation They will be measured heart rate and blood pressure. Receives: Other: Progressive muscle relaxation exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Mini Mental Test (SMMT)
SMMT evaluates cognitive status. Seniors with a SMMT score above 23 (min.0 - max. 30) were included in the study.
Measured: pretest of study
Secondary outcomes (2)
Nottingham Health Profile
The health-related quality of life of elderly individuals was evaluated using the Nottingham Health Profile (NHP). he lowest and highest scores that can be obtained from each sub-dimension of the scale are 0 and 100, respectively. 0 indicates the best health status while 100 indicates the worst health status.
Measured: 2 months
Assessment Scale of Adaptation Difficulty for the Elderly (ASADE)
The difficulties in adaptation to old age of elderly individuals were evaluated using the Assessment Scale of Adaptation Difficulty for the Elderly (ASADE). The scores obtained from the items of the scale (24 ıtems) are collected and divided by the number of questions to obtain the total score of the scale. The level of adaptation to old age decreases as the score obtained from the scale by an individual increases. ASADE total score min. 0- max. 3.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start13 May 2019
- Primary completion10 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older PeopleStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemile KÜTMEÇ YILMAZ, Aksaray University Training and Research Hospital
- Investigators
- Cemile KÜTMEÇ YILMAZ, Principal investigator, Aksaray University, Faculty of Health Science, Nursing Department, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148196
- Sponsor's protocol ID
- 2019/23
- Status last verified
- Feb 2021
- First submitted
- 30 Oct 2019
- Last updated
- 17 Feb 2021
- Results posted
- No
- 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 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progressive Muscle Relaxation on Adaptation to Old Age and Quality of Life Among Older People in a Nursing Home: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04148196
- Acronym / sponsor ID
- 2019/23
- Conditions
- Older People
- Keywords
- Older people, Adaptation, Life quality, Nursing home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Aksaray University Training and Research HospitalUniversity, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 1 Nov 2019 (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.
The changes and limitations that occur in the aging process effect people's adaptation toold age. The quality of life of elderly individuals who have problems in adaptation to aging is negatively affected. This study aimed to assess the effect of effects of Progressive Muscle Relaxation on the adaptation levels and quality of life of the elderly living in nursing homes.
Detailed description
Today, changes and developments in technology and lifestyles have lengthened average life span and increased the elderly population. The physical and cognitive changes, health problems, new roles such asbeing retired or widowed and economic losses come one after anotherfor the elderly, and this turns the old age into a period full of difficul-ties. The difficulties experienced in this period introduce problems re-lated to the adaptation of the elderly to old age. The union of the problems arising due to old age decreases the self-respect and life satisfaction of the elderly individual, and consequently, the quality of life can be negatively affected.
Adaptation is defined as the harmony built by an individual between his own needs and the expectations of the people around.It is important for people to adapt to ever-changing life events sothat they can lead happy lives.The first condition of a healthy and problem-free old age is to accept and adapt to old age.Therefore, the purposes of nursing care cover ensuring an individual's adaptation toold age and its changes, which is the last development phase of life.
Nurses can positively change people's adaptation to old age by applying simple andeconomic non-pharmacological methods that are easy to apply. The non-pharmacological methods used in this study for older people'sw included progressive muscle relaxation exercise. It is stated in the literature that progressive relaxation exercise increases the quality of life and satisfaction of elderly individuals. However, there was no study thatassessed the effect of progressive muscle relaxation exercise on adaptation to old age.
Objective: Evaluate the effects of progressive muscle relaxation on the adaptation levels older people's and quality of life of the elderly living in nursing homes.
Methodology: This is randomized clinical test. The sample was made up of 45 older people living in nursing homes (24 in control group and 21 in the experimental group). The progressive muscle relaxation technique was employed. In order to collect the data, we adopted the interview with form filling technique, using the introductory information form, Assessment Scale of Adaptation Difficulty for the Elderly (ASADE) and Nottingham Health Profile (NHP)". Blood pressure and heart rate of experimental group were measured before and after the progressive muscle relaxation intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –older people's who have a Standard Mini Mental Test score of 23 and above, living in nursing homes. |
| Experimental group | Experimental | Other: Progressive muscle relaxation exerciseIntervention group: older people's who have a Standard Mini Mental Test score of 23 and above, living in nursing homes.The researcher will perform 16 sessions of progressive relaxation exercises twice a week for 8 weeks. Each PMR exercise was conducted under the guidance of the researcher. Before and after each session of the Progressive Muscle Relaxation They will be measured heart rate and blood pressure. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 years and above,
- Do not have a diagnosis of dementia and psychiatric disease by the doctor and have a mini-mental test score of 23 and above,
- There is no problem with communication
Key exclusion criteria (2 listed)
- Having severe hearing or perceptual deficits that impaired communication
- Having dementia, Alzheimer's disease,
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 |
|---|---|---|
| Progressive muscle relaxation exerciseThe CD on relaxation exercises developed by the Turkish Psy-chological Associationwas used.In the second of CD 27-min section; relaxation exercises are explained to the accompaniment ofrunning water sounds and verbal instructions. Progressive relaxation technique includes stretching and relaxing the bigmuscle groups (hands, arms, neck, shoulders, face, chest, abdomen,hip, feet andfingers) in the human body on purpose. When steps ofProgressive Relaxation Exercises are analyzed, it is observed thatlearning how to take correct and deep breaths is the most impor-tant step towards learning relaxation. In addition, taking correct breaths is used as a part of the exercise among all relaxation exercises.Steps of Progressive Relaxation Exercise:- breathing exercises- lower extremity exercises- upper extremity exercises- exercise of respiratory muscles. Elderly individuals will receive PMR exercise twice a week under the guidance of an investigator for eight weeks. | Other | Experimental group |
Primary outcome
Standard Mini Mental Test (SMMT)
Time frame: pretest of study
SMMT evaluates cognitive status. Seniors with a SMMT score above 23 (min.0 - max. 30) were included in the study.
2 secondary outcomes
Nottingham Health Profile
Time frame: 2 months
Assessment Scale of Adaptation Difficulty for the Elderly (ASADE)
Time frame: 2 months
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 17 Feb 2021.
- 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.
Cemile KÜTMEÇ YILMAZ principal investigator
Aksaray University, Faculty of Health Science, Nursing Department, Turkey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive muscle relaxation exercise in people with Older People, run by Aksaray University Training and Research Hospital at 2 sites in Turkey (Türkiye).
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 3 inclusion and 2 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 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Standard Mini Mental Test (SMMT) (time frame: pretest of study). 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 17 Feb 2021.