Effects of the Programme Developed for Sedentary Elderly in the COVID-19 Pandemic: Mobile Interventional Study
Primary Purpose
Aged
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
"Stay at Home Take a Step Program (SHTSP)"
Sponsored by

About this trial
This is an interventional prevention trial for Aged focused on measuring COVID 19, Elderly, Step Count, Walking
Eligibility Criteria
Inclusion Criteria:
- Those who volunteered to participate in the study
- No mental disability,
- Can read and write Turkish
- Using a smartphone
- No muscle-joint problems that interfere with physical activity
- No neuropsychiatric disorder
- No cognitive problem that prevents communication
- Not diagnosed as COVID 19 positive
- Able to carry out activities of daily living independently
- All individuals aged 65 and over will be included. Sedentary elderly people who take an average of 2000 or less steps per day
Exclusion Criteria:
- Having insulin-dependent Type 2 diabetes
- Having hypertension and not being able to control it with medication
- Being diagnosed with Heart Failure
- Being diagnosed with chronic obstructive pulmonary disease
- Being diagnosed with asthma
- Being diagnosed with cancer
Sites / Locations
- Namik Kemal University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
intervention group
Arm Description
step counts will be followed
The Stay at Home Take a Step Program consisting of video or audio calls four times, sending Short Message Service messages containing reminders to encourage walking, and daily step count and weight tracking will be implemented.
Outcomes
Primary Outcome Measures
Daily steps
Daily walking amount will be assessed by number of steps/day. The number of steps of the participants will be measured and recorded with the pedometer device.
The sedentary elderly who took an average of 2000 or less steps per day were included in the study.
EuroQoL Quality of Life Scale
Quality of Life will be assessed by EuroQoL Quality of Life Scale total point. Scale consists of two parts: Part 1 defines the health profile in five dimensions. Each dimension contains three statements according to difficulty (1 some problem; 2 moderate; 3 a lot of problems), part 2 includes a visual analog scale where respondents rate their current state of health on a scale of 0 to 100.
Stress level
Stress level will be assessed by Perceived Stress Scale total point. Perceived Stress Scale is evaluated over the total score and the scores are calculated between 10-50. A score of 30 and above indicates that the individual has stress. As the score increases, the stress level also increases.
Secondary Outcome Measures
Full Information
NCT ID
NCT05110560
First Posted
October 6, 2021
Last Updated
November 3, 2021
Sponsor
Namik Kemal University
1. Study Identification
Unique Protocol Identification Number
NCT05110560
Brief Title
Effects of the Programme Developed for Sedentary Elderly in the COVID-19 Pandemic: Mobile Interventional Study
Official Title
Effects of the "Stay at Home-Take a Step" Programme Developed for Sedentary Elderly in the COVID-19 Pandemic: Mobile Interventional Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Namik Kemal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of all these applications is the same: people keep distance and isolate themselves from those in risk groups and patients. In Turkey, it was announced by the Ministry of Health (2020) that the first official COVID-19 case was seen on March 11, 2020. Immediately afterwards, many pioneering measures were taken, such as travel restrictions, mandatory quarantine practices for those with a foreign history, interruption of primary, secondary and higher education, closure of common areas curfews. In order to minimize contact and ensure social isolation, home quarantine practice was encouraged with the 'Stay at Home Turkey' campaign. Within the scope of the measures taken, a curfew was imposed for citizens over 65 years of age who are considered to be risky in terms of high death rate and who have chronic diseases, as of 21 March - 9 June 2020, and the elderly population became the first group to leave social environments in our country. However, quarantine and social isolation for the elderly population due to increased sedentary lifestyle and loneliness pose a serious public health problem. The COVID-19 epidemic has affected health and quality of life in many ways, and one of the most affected areas has been healthy lifestyle behaviors.
Especially sedentary and sedentary life is of vital importance for the elderly. When the literature in this field is examined, it is shown that physical activity reduces the risk of premature death, supports positive mental health and supports healthy aging More importantly, physical activity sessions don't have to be long to improve health; 10-minute bouts of moderate to vigorous physical activity are beneficial for the prevention and control of diseases, and even light activity such as moderate-paced walking is beneficial. In addition, emphasized that walking is a low-cost activity that, if done at recommended levels, can reduce the incidence of chronic diseases and associated health care costs. No expensive equipment or gym membership required to walk; most people can do this by incorporating it into their daily life. In this study, which is planned from here, it is aimed to examine the effect of the stay at home program, which is carried out with the mobile initiative to gain exercise behavior in elderly individuals over the age of 65 who are under mandatory quarantine at their homes during the COVID 19 pandemic process, on the number of steps, quality of life and stress level.
Detailed Description
Type of Research The study was designed as a randomised controlled study with the control group Research Sample
The population of the study consists of individuals over the age of 65 in Turkey during the COVID 19 pandemic. For this purpose, information messages were sent to Tekirdag Namik Kemal University undergraduate students who continue their distance education between 15 May-1 June. The students were asked to invite individuals aged 65 and over who are in their immediate environment (relatives, neighbors, etc.) who meet the inclusion criteria to participate in the study. All volunteer participants in the determined date section were called by phone and their compliance with the inclusion and exclusion criteria was evaluated. All participants meeting the inclusion criteria were included in the study population (n= 94). If the minimum sample size cannot be reached, it is planned to extend the participation period in the study. The sample size was calculated using the G Power program to calculate the minimum number of samples to be used in the study. In determining the sample size, considering the previously published articles in which similar interventions were applied, Type 1 error amount was 0.05, test power was 0.95, and effect size: 0.83; The minimum number of samples required was determined as 64 (32 experimental + 32 control group) for the experimental and control groups. All participants meeting the inclusion criteria were randomly divided into experimental and control groups by a statistician outside the study using the Random Online Allocation Software program (www.Graphpad.com). A double-blind technique was used in the assignment of the groups.
Research Process After obtaining the ethics committee and institutional permissions for the research, "Socio-demographic information form", "EuroQOL General Quality of Life Scale" and "Perceived Stress Scale" online questionnaires were applied to all elderly people who met the inclusion criteria as a pre-test. Elderly people who have vision problems and could not answer the online questionnaire were asked to read and answer questions by telephone interview. In addition, a pedometer device was sent to all the elderly in the experimental and control groups. It will be explained in detail how to use it, and they will be asked to record the number of steps and weights on the "Following Chart" for 2 months. Unlike the control group, the intervention group will be applied to the "Stay at Home Step by Step Program" (EKAAP), which will last for 4 weeks.
As a post-test, "Socio-demographic information form", "EuroQOL General Quality of Life Scale" and "Perceived Stress Scale" will be applied to both the experimental and control groups. One month after the intervention is completed, it will be possible to monitor the change in step counts, weight values, EuroQOL General Quality of Life Scale and Perceived Stress Scale scores of the elderly.
Data Collection Tools
Socio-Demographic Information Form The Descriptive Questionnaire was created by the researchers by examining the relevant literature. This form includes questions about socio-demographic characteristics (age, marital status, gender, education level, number of children, people with whom they live, place of residence, household size, employment status).
EuroQOL General Quality of Life Scale It is a scale developed to assess health-related quality of life. It consists of two parts: Chapter 1 defines the health profile in five dimensions (mobility, self-care, social life, pain and psychological state). Each dimension contains three statements according to difficulty (1 a little problem; 2 medium; 3 a lot of problems), Section 2 includes the visual analog scale, in which respondents rate their current health status on a scale of 0 to 100. Easy to apply and quickly identified.Turkish validity and reliability were done by Kahyaoglu Süt and Ünsar.
Perceived Stress Scale The scale was developed by Cohen et al. Its validity and reliability study was conducted by Erci, and it was determined that it was adapted to Turkish society and appropriate.The scale consists of 10 items, and each item receives 1, 2, 3, 4, 5 points, respectively.The scale is evaluated over the total score and the scores are calculated between 10-50. A score of 30 and above indicates that the individual has stress. As the score increases, the stress level also increases. In the validity and reliability study of the scale, it was determined that the test-retest correlation was 0.88.
Statistical procedure
Percentage, mean, standard deviation will be used in the evaluation of the data. Chi-square, Fisher's exact test, independent paired T-test and Mann-Whitney U test will be used for comparison between groups and within groups. p <0.05 will be considered statistically significant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aged
Keywords
COVID 19, Elderly, Step Count, Walking
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
"Stay at Home Take a Step Program (SHTSP)" will be performed with the intervention group.
For the control group, only the number of steps will be followed.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
step counts will be followed
Arm Title
intervention group
Arm Type
Experimental
Arm Description
The Stay at Home Take a Step Program consisting of video or audio calls four times, sending Short Message Service messages containing reminders to encourage walking, and daily step count and weight tracking will be implemented.
Intervention Type
Behavioral
Intervention Name(s)
"Stay at Home Take a Step Program (SHTSP)"
Intervention Description
The Stay at Home Take a Step Program consisting of video or audio calls four times, sending Short Message Service messages containing reminders to encourage walking, and daily step count and weight tracking will be implemented.
Primary Outcome Measure Information:
Title
Daily steps
Description
Daily walking amount will be assessed by number of steps/day. The number of steps of the participants will be measured and recorded with the pedometer device.
The sedentary elderly who took an average of 2000 or less steps per day were included in the study.
Time Frame
from the start of the study to the first month
Title
EuroQoL Quality of Life Scale
Description
Quality of Life will be assessed by EuroQoL Quality of Life Scale total point. Scale consists of two parts: Part 1 defines the health profile in five dimensions. Each dimension contains three statements according to difficulty (1 some problem; 2 moderate; 3 a lot of problems), part 2 includes a visual analog scale where respondents rate their current state of health on a scale of 0 to 100.
Time Frame
after attempt completion and one month later
Title
Stress level
Description
Stress level will be assessed by Perceived Stress Scale total point. Perceived Stress Scale is evaluated over the total score and the scores are calculated between 10-50. A score of 30 and above indicates that the individual has stress. As the score increases, the stress level also increases.
Time Frame
after attempt completion and one month later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Those who volunteered to participate in the study
No mental disability,
Can read and write Turkish
Using a smartphone
No muscle-joint problems that interfere with physical activity
No neuropsychiatric disorder
No cognitive problem that prevents communication
Not diagnosed as COVID 19 positive
Able to carry out activities of daily living independently
All individuals aged 65 and over will be included. Sedentary elderly people who take an average of 2000 or less steps per day
Exclusion Criteria:
Having insulin-dependent Type 2 diabetes
Having hypertension and not being able to control it with medication
Being diagnosed with Heart Failure
Being diagnosed with chronic obstructive pulmonary disease
Being diagnosed with asthma
Being diagnosed with cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NURHAN ÖZPANCAR
Organizational Affiliation
Namik Kemal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
AYLİN YALÇIN IRMAK
Organizational Affiliation
Namik Kemal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Namik Kemal University
City
Tekirdag
State/Province
Süleymanpasa
ZIP/Postal Code
59030
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30219032
Citation
Sipila S, Tirkkonen A, Hanninen T, Laukkanen P, Alen M, Fielding RA, Kivipelto M, Kokko K, Kulmala J, Rantanen T, Sihvonen SE, Sillanpaa E, Stigsdotter-Neely A, Tormakangas T. Promoting safe walking among older people: the effects of a physical and cognitive training intervention vs. physical training alone on mobility and falls among older community-dwelling men and women (the PASSWORD study): design and methods of a randomized controlled trial. BMC Geriatr. 2018 Sep 15;18(1):215. doi: 10.1186/s12877-018-0906-0.
Results Reference
result
PubMed Identifier
25760119
Citation
Branco JC, Jansen K, Sobrinho JT, Carrapatoso S, Spessato B, Carvalho J, Mota J, da Silva RA. Physical benefits and reduction of depressive symptoms among the elderly: results from the Portuguese "National Walking Program". Cien Saude Colet. 2015 Mar;20(3):789-95. doi: 10.1590/1413-81232015203.09882014.
Results Reference
result
PubMed Identifier
28974482
Citation
Rye Hanton C, Kwon YJ, Aung T, Whittington J, High RR, Goulding EH, Schenk AK, Bonasera SJ. Mobile Phone-Based Measures of Activity, Step Count, and Gait Speed: Results From a Study of Older Ambulatory Adults in a Naturalistic Setting. JMIR Mhealth Uhealth. 2017 Oct 3;5(10):e104. doi: 10.2196/mhealth.5090.
Results Reference
result
Learn more about this trial
Effects of the Programme Developed for Sedentary Elderly in the COVID-19 Pandemic: Mobile Interventional Study
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