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

NCT05280249 | Unknown

• 1 other identifier: 07.03.2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Elderly; Exercise

Keywords

elderly; exercise; Affective Symptoms; anxiety; depression

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

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.

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.

Interventions

both aerobic and resistance exercises in the green exercise concept OTHER

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.

Both aerobic and resistance exercises in the green exercise concept

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, 34854, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Motor Activity; Affective Symptoms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluations will be made by an impartial researcher who was not involved in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Parallel Assignment Parallel Assignment Randomized

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 15, 2022
• Study Start: April 4, 2022
• Primary Completion: September 12, 2022
• Study Completion: October 17, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)