ElderlyNCT05280249
The Effects of Green Exercise Program Consisting of 12-week Aerobic and Resistance Exercises on Sleep Quality, Alexithymia, Anxiety and Depression in Elderly People
A study testing both aerobic and resistance exercises in the green exercise concept in people with Elderly and Exercise, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of combination of aerobic and resistance exercises in the green exercise concept on depression, anxiety, alexithymia and sleep quality of elderly individuals. Elderly individuals over the age of 65 will be included in the study. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- What is being tested?
- both aerobic and resistance exercises in the green exercise concept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2022to 17 Oct 2022
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- people aged over 65 years
- Be fit to participate in exercise program after the first cardiac examination by the physician
- Having a score above 24 in the Minimental Test
Who cannot join
- Having neuromuscular disease
- Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.)
- Having an orthopedic disease that interferes with walking
- Having a score below 24 in the Minimental Test
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medeniyet University
Istanbul, 34854
EMEL METE, +905376096265, e_emel86@hotmail.com
e_emel86@hotmail.com
About this study
The aim of this study is to investigate the effects of combination of aerobic and resistance exercises in the green exercise concept on depression, anxiety, alexithymia and sleep quality of elderly individuals. Elderly individuals over the age of 65 will be included in the study. Two groups of 20 people each will take part in the study. One group will be given aerobic and resistance exercises for 12 weeks, 2 days a week in the green exercise concept, the other group will be the control group and will not be included in the exercise program. Participants will be evaluated twice, at the beginning of the study and at the end of 12 weeks.
Read the detailed description
Forty volunteer participants aged 65 years over will be included in the study. Participants will be randomly divided into two groups as experimental and control group. While experimental group will receive both aerobic and resistance exercises and control group will receive no exercise. Exercises will be held in an open and green area. Depression, anxiety, alexithymia and sleep quality of elderly individuals will be evaulated at the beginning of the treatment and at the end of the twelfth week. The exercise program will be done for 12 weeks, 2 days a week.
- Being tested
- both aerobic and resistance exercises in the green exercise concept
- Keywords
- elderly, exercise, Affective Symptoms, anxiety, depression
- Medical subject headings
- Motor Activity, Affective Symptoms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
both aerobic and resistance exercises in the green exercise conceptOther
Green exercise is a type of exercise done outdoors. It is an advantageous type of exercise in benefiting from sunlight and reducing anxiety. Participants in this group will be given aerobic and resistance exercises in the open air.
| Study group | Role | What they receive |
|---|---|---|
| Both aerobic and resistance exercises in the green exercise concept | Experimental | Green exercise is a type of exercise done outdoors. It is an advantageous type of exercise in benefiting from sunlight and reducing anxiety. Participants in this group will be given aerobic and resistance exercises in the open air. For 20 participants who met the inclusion criteria, first 10 minutes of warm-up exercises, then 20 minutes of moderate-intensity (65% of heart rate) walking, followed by 15 minutes of low-intensity (50% of the maximum repetitions) resistance exercises will be trained in the presence of a physiotherapist. resistance exercises will be performed for shoulder flexors and abductors, elbow flexors and extensors, hip flexors and extensors, knee flexors and extensors, hip abductor muscle groups. At the end of each session, 5 minutes of stretching exercises will also be trained. Receives: Other: both aerobic and resistance exercises in the green exercise concept |
| Control group | No intervention | The exercise program will not be implemented. Evaluations will be made at the beginning and end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Sleep quality will be evaulated with Pittsburg Sleep Quality Index (PUKI). PUKI was developed by Buysee et al. in 1989 and provides a quantitative measure of sleep quality. It contains a total of 24 questions. Each item is scored between 0-3 points. It has 7 components (subjective sleep quality, sleep duration, sleep disturbance, sleep latency, habitual sleep efficiency, sleep medication use, daytime dysfunction). The sum of the scores of these seven components gives the total index score. High scores indicate poor sleep quality.
Measured: Change from baseline sleep quality at week 12.
Anxiety
Anxiety will be evaluated with Geriatric Anxiety Scale. It is a self-filled scale developed for the elderly, observing anxiety symptoms, having somatic, cognitive and affective subscales. It is a 4-point Likert scale scored between 0-3 and consists of 30 questions in total. Items between 24 and 28 are not included in the total score, clinicians use these items to determine the domain of anxiety. The total score ranges from 0 to 75. A high score indicates a high level of anxiety.
Measured: Change from baseline anxiety level at week 12.
Depression
Depression will be assessed with the Geriatric Depression Scale. GDS is a self-reported scale consisting of 30 questions and asked to be answered in a yes/no format. In scoring the scale, 1 point is given for each answer in favor of depression, 0 point is given for the other answer, and the total score is accepted as the depression score. The scores that can be obtained from the scale are between 0-30.
Measured: Change from baseline depression level at week 12.
Alexithymia
Alexithymia, also called emotional deafness, is a psychopathology characterized by difficulties in understanding, defining and expressing their own emotions. Alexithymia will be evaulated Toronto Alexithymia Scale-20. It is a Likert-type scale scored between 1 and 5, and includes 20 questions in total. Items 4,5,10,18 and 19 are reverse scored. Those with a total score of 61 and above are considered to have alexithymia.
Measured: Change from baseline alexithymia level at week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start4 Apr 2022
- Primary completion12 Sep 2022 (estimated)
- Study completion17 Oct 2022 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Parallel Assignment Randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Mete, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280249
- Sponsor's protocol ID
- 07.03.2022
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2022
- Last updated
- 26 Aug 2022
- 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 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Green Exercise Program Consisting of 12-week Aerobic and Resistance Exercises on Sleep Quality, Alexithymia, Anxiety and Depression in Elderly People
- ClinicalTrials.gov ID
- NCT05280249
- Acronym / sponsor ID
- 07.03.2022
- Keywords
- elderly, exercise, Affective Symptoms, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 12 Sep 2022 (estimated)
- Study completion
- 17 Oct 2022 (estimated)
- First posted
- 15 Mar 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.
The aim of this study is to investigate the effects of combination of aerobic and resistance exercises in the green exercise concept on depression, anxiety, alexithymia and sleep quality of elderly individuals. Elderly individuals over the age of 65 will be included in the study. Two groups of 20 people each will take part in the study. One group will be given aerobic and resistance exercises for 12 weeks, 2 days a week in the green exercise concept, the other group will be the control group and will not be included in the exercise program. Participants will be evaluated twice, at the beginning of the study and at the end of 12 weeks.
Detailed description
Forty volunteer participants aged 65 years over will be included in the study. Participants will be randomly divided into two groups as experimental and control group. While experimental group will receive both aerobic and resistance exercises and control group will receive no exercise. Exercises will be held in an open and green area. Depression, anxiety, alexithymia and sleep quality of elderly individuals will be evaulated at the beginning of the treatment and at the end of the twelfth week. The exercise program will be done for 12 weeks, 2 days a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment Parallel Assignment Randomized
| Arm | Type | Receives |
|---|---|---|
| Both aerobic and resistance exercises in the green exercise concept | Experimental | Other: both aerobic and resistance exercises in the green exercise conceptGreen exercise is a type of exercise done outdoors. It is an advantageous type of exercise in benefiting from sunlight and reducing anxiety. Participants in this group will be given aerobic and resistance exercises in the open air. For 20 participants who met the inclusion criteria, first 10 minutes of warm-up exercises, then 20 minutes of moderate-intensity (65% of heart rate) walking, followed by 15 minutes of low-intensity (50% of the maximum repetitions) resistance exercises will be trained in the presence of a physiotherapist. resistance exercises will be performed for shoulder flexors and abductors, elbow flexors and extensors, hip flexors and extensors, knee flexors and extensors, hip abductor muscle groups. At the end of each session, 5 minutes of stretching exercises will also be trained. |
| Control group | No intervention | –The exercise program will not be implemented. Evaluations will be made at the beginning and end of the study. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- people aged over 65 years
- Be fit to participate in exercise program after the first cardiac examination by the physician
- Having a score above 24 in the Minimental Test
Key exclusion criteria (4 listed)
- Having neuromuscular disease
- Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.)
- Having an orthopedic disease that interferes with walking
- Having a score below 24 in the Minimental Test
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 |
|---|---|---|
| both aerobic and resistance exercises in the green exercise conceptGreen exercise is a type of exercise done outdoors. It is an advantageous type of exercise in benefiting from sunlight and reducing anxiety. Participants in this group will be given aerobic and resistance exercises in the open air. | Other | Both aerobic and resistance exercises in the green exercise concept |
Primary outcome
Sleep quality
Time frame: Change from baseline sleep quality at week 12.
Sleep quality will be evaulated with Pittsburg Sleep Quality Index (PUKI). PUKI was developed by Buysee et al. in 1989 and provides a quantitative measure of sleep quality. It contains a total of 24 questions. Each item is scored between 0-3 points. It has 7 components (subjective sleep quality, sleep duration, sleep disturbance, sleep latency, habitual sleep efficiency, sleep medication use, daytime dysfunction). The sum of the scores of these seven components gives the total index score. High scores indicate poor sleep quality.
Anxiety
Time frame: Change from baseline anxiety level at week 12.
Anxiety will be evaluated with Geriatric Anxiety Scale. It is a self-filled scale developed for the elderly, observing anxiety symptoms, having somatic, cognitive and affective subscales. It is a 4-point Likert scale scored between 0-3 and consists of 30 questions in total. Items between 24 and 28 are not included in the total score, clinicians use these items to determine the domain of anxiety. The total score ranges from 0 to 75. A high score indicates a high level of anxiety.
Depression
Time frame: Change from baseline depression level at week 12.
Depression will be assessed with the Geriatric Depression Scale. GDS is a self-reported scale consisting of 30 questions and asked to be answered in a yes/no format. In scoring the scale, 1 point is given for each answer in favor of depression, 0 point is given for the other answer, and the total score is accepted as the depression score. The scores that can be obtained from the scale are between 0-30.
Alexithymia
Time frame: Change from baseline alexithymia level at week 12.
Alexithymia, also called emotional deafness, is a psychopathology characterized by difficulties in understanding, defining and expressing their own emotions. Alexithymia will be evaulated Toronto Alexithymia Scale-20. It is a Likert-type scale scored between 1 and 5, and includes 20 questions in total. Items 4,5,10,18 and 19 are reverse scored. Those with a total score of 61 and above are considered to have alexithymia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing both aerobic and resistance exercises in the green exercise concept in people with Elderly and Exercise, run by Istanbul Medeniyet 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 3 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: status not confirmed, as of the sponsor's last update on 26 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: Change from baseline sleep quality at week 12.). The study lists 4 primary outcomes in all. 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 26 Aug 2022.