The Effects of Green Exercise Program Consisting of 12-week Aerobic and Resistance Exercises on Sleep Quality, Alexithymia, Anxiety and Depression in Elderly People

Exercise Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05280249
• Other study ID #: 07.03.2022
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: October 17, 2022

Study information

• Verified date: March 2022
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 17, 2022
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Affective Symptoms
• Depression
• Elderly
• Exercise

Intervention

Other:
• both aerobic and resistance exercises in the green exercise concept
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.

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline sleep quality at week 12.
Primary	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.	Change from baseline anxiety level at week 12.
Primary	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.	Change from baseline depression level at week 12.
Primary	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.	Change from baseline alexithymia level at week 12.