NCT05280249|Unknown
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Sponsor study identifier
interventional
40
1 country
1
Study Start
April 4, 2022
Actual (reported)Primary Completion
September 12, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 17, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 17, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 7, 2022
Actual (reported)March 15, 2022
Actual (reported)April 4, 2022
Actual (reported)September 12, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 17, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
The exercise program will not be implemented. Evaluations will be made at the beginning and end of the study.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Istanbul Medeniyet University
Istanbul, 34854, Turkey (Türkiye)
First Submitted
March 7, 2022
First Posted
March 15, 2022
Study Start
April 4, 2022
Actual (reported)Effects Multi-Gravitational Suspension-Based Therapy
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.
Contact the study team to confirm eligibility.
Primary Completion
September 12, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 17, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 26, 2022
Record last verified: 2022-03
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