NCT05110560

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
Last Updated

November 8, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

October 6, 2021

Last Update Submit

November 3, 2021

Conditions

Keywords

COVID 19ElderlyStep CountWalking

Outcome Measures

Primary Outcomes (3)

  • 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.

    from the start of the study to the first month

  • 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.

    after attempt completion and one month later

  • 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.

    after attempt completion and one month later

Study Arms (2)

control group

NO INTERVENTION

step counts will be followed

intervention group

EXPERIMENTAL

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.

Behavioral: "Stay at Home Take a Step Program (SHTSP)"

Interventions

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 group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Namik Kemal University

Tekirdağ, Süleymanpasa, 59030, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • NURHAN ÖZPANCAR

    Namik Kemal University

    PRINCIPAL INVESTIGATOR
  • AYLİN YALÇIN IRMAK

    Namik Kemal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: "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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 6, 2021

First Posted

November 8, 2021

Study Start

June 1, 2021

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

November 8, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations