Healthy LifestyleNCT05100953

Application of Physical Activity Counseling Program

A study testing Physical Activity Counseling in people with Healthy Lifestyle, run by Medipol University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Lifestyle
What is being tested?: Physical Activity Counseling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 5 Oct 2021to 10 Jan 2022
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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Not having a co-morbid disease that would prevent physical activity
Having internet access and equipment to make video calls
Working remotely

Who cannot join

Having a diagnosis of any neurodegenerative or chronic disease
Having significant cardiovascular, neuromuscular or endocrine disorders that limit regular physical activity
Recent myocardial infarction or other acute cardiac event, unstable angina, uncontrolled cardiac arrhythmias
In the past 2 months having had Covid 19

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Medipol University
Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Application of Physical Activity Counseling Program in Healthy Adult Individuals

Abstract Implementation of Physical Activity Counseling Program in Healthy Adult Individuals It was planned to investigate the effects of physical activity counseling on physical fitness level, physical activity level, depression level, sleep quality, quality of life and the change in the number of daily steps. 48 healthy adults aged 18-65 years will be included in the study. Participants will be randomized to the experimental group receiving videoconferencing counseling for eight weeks and the control group receiving single-session informational counseling. Participants will be evaluated with online questionnaires and physical fitness tests during the video conference before the study begins, at the end of the first month and at the end of the second month. Online surveys to be applied; PACE Score, Physical Activity Readiness Questionnaire (PAR-Q), Short Form International Physical Activity Questionnaire (IPAQ-SF), Pittsburgh Sleep Quality Index (PUKI), Beck Depression Inventory (BDI), World Health Organization Quality of Life Scale-Short Form ( WHOQOL-BREF) and physical fitness tests; Plank Test, Curl Up Test, Modified Push Up Test and Squat Test. Demographic information of the participants such as age, weight, height will be recorded. In addition, all participants will record their step counts with the pedometer application they download to their phones one week before the study starts and for one week after the study ends.

Conditions: Healthy Lifestyle
Being tested: Physical Activity Counseling
Keywords: Physical Activity, Quality of Life, Sleep Habits, Depression, Videoconferencing, Telehealth
Medical subject headings: Motor Activity, Depression

What participants receive

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

Physical Activity CounselingBehavioural
Physical activity counseling will be provided under supervision by the researcher physiotherapist via video conference and an individual physical activity program will be organized weekly for two months.

Study groups in NCT05100953
Study group	Role	What they receive
Experimental Group	Experimental	After informing about the benefits of physical activity at the beginning of the study, physical activity counseling will be applied once a week for two months via videoconference. Receives: Behavioral: Physical Activity Counseling
Control Group	No intervention	At the beginning of the study, a one-session briefing will be given on the benefits of physical activity.

What is being measured

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

Physical Activity Level
International Physical Activity Questionnaire of Short Form:IPAQ-SF records the last 7 day recall for four intensity levels of physical activity which is vigorous-intensity activity, moderate-intensity activity, walking, and sitting. From IPAQ-SF, data were converted to Metabolic Equivalent minutes per week (MET-min/week) using. Compendium average MET score (Walking = 3.3 METs, Moderate Physical Activity = 4.0 METs and Vigorous Physical Activity = 8.0 METs).
Measured: first measurement at the beginning of the study,change at first month, change at second month
Depression Level
Beck Depression Scale: BDI scores of 0-13 indicate minimal depression, 14-19 (mild depression), 20-28 (moderate depression) and 29-63 (severe depression).
Measured: first measurement at the beginning of the study,change at first month, change at second month
Sleep Quality
Pittsburgh Sleep Quality Index: In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: first measurement at the beginning of the study,change at first month, change at second month
Life Quality
World Health Organization Quality of Life Scale-Short Form: WHOQOL-BREF is a scale for the quality of life assessment developed by the World Health Organization. It is composed by 26 questions graded from 1 to 5.
Scoring:
1 to 2.9 - needs improvement 3 to 3.9 - regular 4 to 4.9 - good 5 - very good
Question 1 asks about the individual's overall perception of quality of life. Results refer to question 1.
Measured: first measurement at the beginning of the study,change at first month, change at second month
Plank Test
The physical fitness of the participants was evaluated with the Plank Test. The plank test is used to measure the strength and endurance of the core area. The duration of stay in the plank position is recorded by the researcher.
Measured: first measurement at the beginning of the study,change at first month, change at second month
Curl Up Test
The physical fitness of the participants was evaluated with the Curl Up Test. The Curl-Up test is used to evaluate the strength and endurance of the abdominal muscles.The number of repetitions made in one minute is recorded.
Measured: first measurement at the beginning of the study,change at first month, change at second month
Modified Push Up Test
The physical fitness of the participants was evaluated with the Modified Push Up Test. The modified Push Up test evaluates chest muscles and upper extremity endurance.The number of modified push-ups performed correctly in succession without rest in 40 seconds is recorded.
Measured: first measurement at the beginning of the study,change at first month, change at second month
Squat Test
The physical fitness of the participants was evaluated with the Squat Test. The squat test evaluates lower extremity muscle endurance.The number of repetitions that the participant can do in one minute is recorded.
Measured: first measurement at the beginning of the study,change at first month, change at second month
Step Counts
Participants recorded their step counts with a pedometer app they downloaded to their phones.
Measured: first measurement at the beginning of the study, change at second month
Body Mass Index
BMI is calculated by dividing body weight (kg) by the square of the height in meters.
Measured: first measurement at the beginning of the study, change at second month

Timeline

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

5 Oct 202110 Jan 2022

First posted29 Oct 2021
Study start5 Oct 2021
Primary completion20 Dec 2021 (estimated)
Study completion10 Jan 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy LifestyleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 48 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05100953
Sponsor's protocol ID: NKOSE
Status last verified: Oct 2021
First submitted: 5 Oct 2021
Last updated: 29 Oct 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effectiveness of the "Aktivplan" Digital Intervention for Supporting Regular Heart-Healthy Physical Activity Following Phase II Cardiac Rehabilitation
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All Healthy Lifestyle trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of Physical Activity Counseling Program in Healthy Adult Individuals
ClinicalTrials.gov ID: NCT05100953
Acronym / sponsor ID: NKOSE
Conditions: Healthy Lifestyle
Keywords: Physical Activity, Quality of Life, Sleep Habits, Depression, Videoconferencing, Telehealth
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 48 participants (estimated)
Lead sponsor: Medipol UniversityUniversity, hospital or other
Study start: 5 Oct 2021 (actual)
Primary completion: 20 Dec 2021 (estimated)
Study completion: 10 Jan 2022 (estimated)
First posted: 29 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Experimental Group	Experimental	Behavioral: Physical Activity CounselingAfter informing about the benefits of physical activity at the beginning of the study, physical activity counseling will be applied once a week for two months via videoconference.
Control Group	No intervention	–At the beginning of the study, a one-session briefing will be given on the benefits of physical activity.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Not having a co-morbid disease that would prevent physical activity
Having internet access and equipment to make video calls
Working remotely

Key exclusion criteria (4 listed)

Having a diagnosis of any neurodegenerative or chronic disease
Having significant cardiovascular, neuromuscular or endocrine disorders that limit regular physical activity
Recent myocardial infarction or other acute cardiac event, unstable angina, uncontrolled cardiac arrhythmias
In the past 2 months having had Covid 19

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physical Activity CounselingPhysical activity counseling will be provided under supervision by the researcher physiotherapist via video conference and an individual physical activity program will be organized weekly for two months.	Behavioural	Experimental Group

Primary outcome

Physical Activity Level
Time frame: first measurement at the beginning of the study,change at first month, change at second month
International Physical Activity Questionnaire of Short Form:IPAQ-SF records the last 7 day recall for four intensity levels of physical activity which is vigorous-intensity activity, moderate-intensity activity, walking, and sitting. From IPAQ-SF, data were converted to Metabolic Equivalent minutes per week (MET-min/week) using. Compendium average MET score (Walking = 3.3 METs, Moderate Physical Activity = 4.0 METs and Vigorous Physical Activity = 8.0 METs).
Depression Level
Time frame: first measurement at the beginning of the study,change at first month, change at second month
Beck Depression Scale: BDI scores of 0-13 indicate minimal depression, 14-19 (mild depression), 20-28 (moderate depression) and 29-63 (severe depression).
Sleep Quality
Time frame: first measurement at the beginning of the study,change at first month, change at second month
Pittsburgh Sleep Quality Index: In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Life Quality
Time frame: first measurement at the beginning of the study,change at first month, change at second month
World Health Organization Quality of Life Scale-Short Form: WHOQOL-BREF is a scale for the quality of life assessment developed by the World Health Organization. It is composed by 26 questions graded from 1 to 5. Scoring: 1 to 2.9 - needs improvement 3 to 3.9 - regular 4 to 4.9 - good 5 - very good Question 1 asks about the individual's overall perception of quality of life. Results refer to question 1.
Plank Test
Time frame: first measurement at the beginning of the study,change at first month, change at second month
The physical fitness of the participants was evaluated with the Plank Test. The plank test is used to measure the strength and endurance of the core area. The duration of stay in the plank position is recorded by the researcher.
Curl Up Test
Time frame: first measurement at the beginning of the study,change at first month, change at second month
The physical fitness of the participants was evaluated with the Curl Up Test. The Curl-Up test is used to evaluate the strength and endurance of the abdominal muscles.The number of repetitions made in one minute is recorded.
Modified Push Up Test
Time frame: first measurement at the beginning of the study,change at first month, change at second month
The physical fitness of the participants was evaluated with the Modified Push Up Test. The modified Push Up test evaluates chest muscles and upper extremity endurance.The number of modified push-ups performed correctly in succession without rest in 40 seconds is recorded.
Squat Test
Time frame: first measurement at the beginning of the study,change at first month, change at second month
The physical fitness of the participants was evaluated with the Squat Test. The squat test evaluates lower extremity muscle endurance.The number of repetitions that the participant can do in one minute is recorded.
Step Counts
Time frame: first measurement at the beginning of the study, change at second month
Participants recorded their step counts with a pedometer app they downloaded to their phones.
Body Mass Index
Time frame: first measurement at the beginning of the study, change at second month
BMI is calculated by dividing body weight (kg) by the square of the height in meters.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
Individual participant dataSharing planned: Yes

Related trials for Healthy Lifestyle

Recruiting
LIfestyle MEtabotype Study B (LIME-B)
Nutritional and Metabolic Diseases, Prediabetes
Active, not recruiting
The Effect of Lifestyle Program Women With PCOS
Polycystic Ovary Syndrome
Not yet recruiting
Walk Together Efficacy Trial
Hypertension
Not yet recruiting
Effectiveness of the "Aktivplan" Digital Intervention for Supporting Regular Heart-Healthy Physical Activity Following Phase II Cardiac Rehabilitation
Cardiovascular Diseases (CVD)
Active, not recruiting
Group Lifestyle Balance™ for Individuals With Stroke (GLB-CVA)
Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity Counseling in people with Healthy Lifestyle, run by Medipol 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Oct 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?

Results are not available in the source record.

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?

Physical Activity Level (time frame: first measurement at the beginning of the study,change at first month, change at second month). The study lists 10 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 NCT05100953.

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 29 Oct 2021.