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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05519423
Other study ID # 2022/241
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date December 1, 2023

Study information

Verified date March 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The limited number of studies on the effectiveness of physical activity incentive programs for morbidly obese individuals in the literature shows the need in this area. In this study, primary aim is to investigate the effect of physical activity incentive program applied through face-to-face and whatsapp-based applications on physical activity level, functional capacity and muscular endurance in morbidly obese individuals. Secondary aim is to provide individuals with exercise habits and to ensure participants' sustainability with the physical activity incentive program planned in line with the needs of the individual.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Individuals between the ages of 18-60 - BMI =40 kg/m2, morbidly obese awaiting bariatric surgery - No surgical operation in the last 6 months Exclusion Criteria: - Having a musculoskeletal disorder or systemic disease that will interfere with physical activity - Presence of balance problems that will prevent physical activity - Presence of psychiatric or neurological disease affecting cooperation and cognitive functions - Presence of acute pain - Heartache - Having a history of myocardial infarction - Presence of conjunctive heart failure - Presence of uncontrolled diabetes and hypertension

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical Activity Incentive Program
Physical Activity Incentive (PAI) programs, which is a method used in preventive health services, are recommended by a number of public health institutions, including the World Health Organization, thanks to the universal access and high potential of health services. PAI is defined as offering verbal or written advice/guidance to encourage the individual to increase their current level of physical activity.

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185. — View Citation

Physical Activity Strategy for the WHO European Region 2016-2025; World Health Organisation Regional Office for Europe: Copenhagen, Denmark, 2016; ISBN 9289051477.

Solway S, Brooks D, Lacasse Y, Thomas S. A qualitative systematic overview of the measurement properties of functional walk tests used in the cardiorespiratory domain. Chest. 2001 Jan;119(1):256-70. doi: 10.1378/chest.119.1.256. — View Citation

van Poppel MN, Chinapaw MJ, Mokkink LB, van Mechelen W, Terwee CB. Physical activity questionnaires for adults: a systematic review of measurement properties. Sports Med. 2010 Jul 1;40(7):565-600. doi: 10.2165/11531930-000000000-00000. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The International Physical Activity Questionnaires (IPAQ) The short form of the International Physical Activity Questionnaire (IPAQ) will be used to determine the physical activity levels of the participants. The IPAQ-Short Form is a valid tool used to assess physical activity in young adults. It is a 7-item scale that evaluates the duration and frequency of vigorous physical activity, moderate physical activity, walking and sedentary behavior based on MET values. Physical activity levels are classified into 3 categories according to the scores obtained by multiplying the duration, frequency and MET values of the physical activities that the participants participated in within 7 days and for at least 10 minutes. Accordingly, <600 MET - min/week is defined as inactive, 600 - 3000 MET - min/week low, and >3000 MET - min/week is defined as sufficient physical activity level. up to 8 weeks
Secondary Bioelectrical Impedance Analysis (BIA) Measurement The muscle, fat, and water ratio of the cases were evaluated with the Inbody Bioelectrical Impedance Device. up to 8 weeks
Secondary 6 Minute Walk Test According to the guide published by the American Thoracic Society, the 6MWT is easy to administer, better tolerated, and better reflecting daily activities than other walking tests. It can be applied in a short time in a limited space and requires little equipment. 6MWT is used in various disease groups to evaluate functional capacity. up to 8 weeks
Secondary Sit and Stand Test In order to evaluate the muscular endurance of the subjects, the participant sitting in a 43 cm high standard chair with his arms crossed over his shoulders is asked to stand up and sit down quickly for 30 seconds, and the number of repetitions at which full rise is achieved will be recorded. up to 8 weeks
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