Elderly WomenNCT04338230
Progressive Muscle Relaxation and Adaptation to Old Age
A study testing Progressive muscle relaxation exercise in people with Elderly Women, run by Aksaray University at 1 site in Turkey (Türkiye).
Trial summary
Changes and limitations in the aging process affect adaptation to old age. It is important for women to adapt to the problems of old age, find a solution and cope. This study was aimed to determine the effect of progressive muscle relaxation exercises on the level of depression and adaptation to old women. Read more about this study
- Who is it for?
- Ages 65 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Elderly Women
- What is being tested?
- Progressive muscle relaxation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2019to 30 Jun 2020
- 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
- Women only
- 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,
- Being independent in practicing daily living activities
- There is no problem with communication
Who cannot join
- Under the age of 65
- Being addicted in daily life activities
- Being diagnosed with dementia and psychiatric illness
- Mini-mental test score below 23
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progressive Muscle Relaxation on Depression and Adaptation to Old Age of Elderly Women: A Randomized Controlled Trial
Changes and limitations in the aging process affect adaptation to old age. It is important for women to adapt to the problems of old age, find a solution and cope. This study was aimed to determine the effect of progressive muscle relaxation exercises on the level of depression and adaptation to old women.
Read the detailed description
The aging process is considered as a result of the decline observed in basic cognitive functions such as attention, perception, memory, and causes problems in the communication of the elderly with the environment. For these problems, it affects the adaptation of the elderly in his environment and himself.
There are a limited number of studies in the literature to increase the adaptation of older individuals to old age. In the studies in the literature, it was stated that the rate of depression is higher in female individuals, and being male and having a high education level positively affect the adaptation of individuals to old age. In a national study, it was determined that as age increases, adaptation to old age decreases.
Progressive muscle relaxation (PMR), one of the nonpharmacological methods, involves the voluntary stretching and relaxation of large muscle groups (hand-starting, foot-end muscle groups) in the human body. It is known that PMR exercises are frequently used in nursing research because of the effects of reducing anxiety and fatigue and improving sleep quality, and reducing nausea-vomiting. However, no study was found on the effect of depression and adaptation to old age. Due to these positive effects of PMR determined in the literature, it is thought that elderly women can positively affect their levels of depression and adaptation to old age.
Objective: Evaluate the effects of progressive muscle relaxation on the depression and adaptation of elderly women to aging.
Methodology: This is randomized clinical test. The sample was made up of 49 elderly women who applying to the family health center (21 in the experimental group and 28 in control group). The progressive muscle relaxation 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 Geriatric Depression Scale Short Form (GDS-S). Progressive muscle relaxation will be performed for a total of 8 weeks, 3 days a week, for 30 minutes.
- Conditions
- Elderly Women
- Being tested
- Progressive muscle relaxation exercise
- Keywords
- Relaxation exercises, Elderly, Women, Adaptation to old age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive muscle relaxation exerciseOther
"Relaxation Exercises CD Audio Records" prepared by Turkish Psychological Association is used. Before starting the PMR exercises, the woman in the intervention group is provided to lie on a comfortable seat or bed, stretching the muscles of the face and all body for about 10 seconds starting from the hands to the foot in line with the sound recordings of the PKG exercises and then holding the deep breath while each muscle group is stretching, It is applied as a slow release of this breath during relaxation. In this way, the muscle groups in the hands, arms, neck, shoulders, chest, abdomen, hips, feet and fingers, the face and the whole body are tensioned and relaxed, and the woman is relaxed. During the eight-week period, the women are called by the researcher once a week and the exercises are reminded. Home visit There are 2 home visits at week 1 and at week 8. In case of need, repeated home visits are provided to ensure the continuity of the application.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Experimental group | Experimental | Women aged 65 and over (the standardized Mini-Mental State Examination (MMSE) test cognitive levels score of 23 and above points). Progressive muscle relaxation exercises are applied to the intervention group as 30-minute sessions three times a week for eight weeks. Receives: Other: Progressive muscle relaxation exercise |
| No Intervention: Control group | No intervention | Women aged 65 and over (the standardized Mini-Mental State Examination (MMSE) test cognitive levels score of 23 and above points). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Mini Mental Test (SMMT)
SMMT evaluates cognitive status. Women with a SMMT score 23 and above (min.0 - max. 30) were included in the study.
Measured: Pretest of study
Secondary outcomes (2)
Geriatric Depression Scale-Short Form (GDS-SF)
Evaluation of depressive symptoms of elderly individuals. In the evaluation of the scale, the answers to no, positive questions and yes to negative questions were matched by 1 point. A total score of 6 and above is considered significant for the diagnosis of depression.
Measured: 2 month
Assessment Scale of Adaptation Difficulty for the Elderly
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 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start30 Dec 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly WomenStudies 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
- Model description
- A Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur Gökşin, Aksaray University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338230
- Sponsor's protocol ID
- 2018/245
- Status last verified
- Feb 2021
- First submitted
- 4 Apr 2020
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- 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
- The Effect of Progressive Muscle Relaxation on Depression and Adaptation to Old Age of Elderly Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04338230
- Acronym / sponsor ID
- 2018/245
- Conditions
- Elderly Women
- Keywords
- Relaxation exercises, Elderly, Women, Adaptation to old age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aksaray UniversityUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 8 Apr 2020 (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.
Changes and limitations in the aging process affect adaptation to old age. It is important for women to adapt to the problems of old age, find a solution and cope. This study was aimed to determine the effect of progressive muscle relaxation exercises on the level of depression and adaptation to old women.
Detailed description
The aging process is considered as a result of the decline observed in basic cognitive functions such as attention, perception, memory, and causes problems in the communication of the elderly with the environment. For these problems, it affects the adaptation of the elderly in his environment and himself.
There are a limited number of studies in the literature to increase the adaptation of older individuals to old age. In the studies in the literature, it was stated that the rate of depression is higher in female individuals, and being male and having a high education level positively affect the adaptation of individuals to old age. In a national study, it was determined that as age increases, adaptation to old age decreases.
Progressive muscle relaxation (PMR), one of the nonpharmacological methods, involves the voluntary stretching and relaxation of large muscle groups (hand-starting, foot-end muscle groups) in the human body. It is known that PMR exercises are frequently used in nursing research because of the effects of reducing anxiety and fatigue and improving sleep quality, and reducing nausea-vomiting. However, no study was found on the effect of depression and adaptation to old age. Due to these positive effects of PMR determined in the literature, it is thought that elderly women can positively affect their levels of depression and adaptation to old age.
Objective: Evaluate the effects of progressive muscle relaxation on the depression and adaptation of elderly women to aging.
Methodology: This is randomized clinical test. The sample was made up of 49 elderly women who applying to the family health center (21 in the experimental group and 28 in control group). The progressive muscle relaxation 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 Geriatric Depression Scale Short Form (GDS-S). Progressive muscle relaxation will be performed for a total of 8 weeks, 3 days a week, for 30 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental group | Experimental | Other: Progressive muscle relaxation exerciseWomen aged 65 and over (the standardized Mini-Mental State Examination (MMSE) test cognitive levels score of 23 and above points). Progressive muscle relaxation exercises are applied to the intervention group as 30-minute sessions three times a week for eight weeks. |
| No Intervention: Control group | No intervention | –Women aged 65 and over (the standardized Mini-Mental State Examination (MMSE) test cognitive levels score of 23 and above points). |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 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,
- Being independent in practicing daily living activities
- There is no problem with communication
Key exclusion criteria (4 listed)
- Under the age of 65
- Being addicted in daily life activities
- Being diagnosed with dementia and psychiatric illness
- Mini-mental test score below 23
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 exercise"Relaxation Exercises CD Audio Records" prepared by Turkish Psychological Association is used. Before starting the PMR exercises, the woman in the intervention group is provided to lie on a comfortable seat or bed, stretching the muscles of the face and all body for about 10 seconds starting from the hands to the foot in line with the sound recordings of the PKG exercises and then holding the deep breath while each muscle group is stretching, It is applied as a slow release of this breath during relaxation. In this way, the muscle groups in the hands, arms, neck, shoulders, chest, abdomen, hips, feet and fingers, the face and the whole body are tensioned and relaxed, and the woman is relaxed. During the eight-week period, the women are called by the researcher once a week and the exercises are reminded. Home visit There are 2 home visits at week 1 and at week 8. In case of need, repeated home visits are provided to ensure the continuity of the application. | Other | Experimental: Experimental group |
Primary outcome
Standardized Mini Mental Test (SMMT)
Time frame: Pretest of study
SMMT evaluates cognitive status. Women with a SMMT score 23 and above (min.0 - max. 30) were included in the study.
2 secondary outcomes
Geriatric Depression Scale-Short Form (GDS-SF)
Time frame: 2 month
Assessment Scale of Adaptation Difficulty for the Elderly
Time frame: 2 month
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Elderly Women, run by Aksaray University at 1 site 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 4 inclusion and 4 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 1 site 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?
Standardized 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.