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AgedNCT05110560

Effects of the Programme Developed for Sedentary Elderly in the COVID-19 Pandemic: Mobile Interventional Study

A study testing "Stay at Home Take a Step Program (SHTSP)" in people with Aged, run by Namik Kemal University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Aged
What is being tested?
"Stay at Home Take a Step Program (SHTSP)"
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2021to 1 Sep 2021
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Namik Kemal University

    Tekirdağ, Süleymanpasa, 59030

Other trials in Turkey (Türkiye)

About this 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

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.

Read the 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

  1. 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).
  2. 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.
  3. 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.

Conditions
Aged
Being tested
"Stay at Home Take a Step Program (SHTSP)"
Keywords
COVID 19, Elderly, Step Count, Walking
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "Stay at Home Take a Step Program (SHTSP)"Behavioural

    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.

Study groups in NCT05110560
Study groupRoleWhat they receive
control groupNo interventionstep counts will be followed
intervention groupExperimentalThe 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.
Receives: Behavioral: "Stay at Home Take a Step Program (SHTSP)"

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: from the start of the study to the first month

  2. 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.

    Measured: after attempt completion and one month later

  3. 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.

    Measured: after attempt completion and one month later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2021
  2. Study start1 Jun 2021
  3. Primary completion1 Aug 2021
  4. Study completion1 Sep 2021

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05110560
Sponsor's protocol ID
Namik Kemal University
Status last verified
Nov 2021
First submitted
6 Oct 2021
Last updated
8 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30219032
  • 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.

    PubMed 25760119
  • 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.

    PubMed 28974482

Questions about this trial

What is this clinical trial studying?

A study testing "Stay at Home Take a Step Program (SHTSP)" in people with Aged, run by Namik Kemal 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 10 inclusion and 6 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: finished, as of the sponsor's last update on 8 Nov 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily steps (time frame: from the start of the study to the first month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05110560, which also lists 3 linked publications.

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 8 Nov 2021.

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