The Effect of Change Stage-Based Physical Activity Counseling on Physically Inactive Individuals With Hypertension

NCT07068100 | Completed

• 1 other identifier: E2-24-6192
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension (HT) is the second most common disease in Turkey and its prevalence is between 30-35%. Adopting healthy lifestyle behaviors can contribute to the prevention of chronic diseases by preserving well-being. However, it has been determined that the control and protection behaviors of HT patients are inadequate. Guidelines for preventing HT recommend weight loss, healthy nutrition, increased physical activity and reduced alcohol consumption. Obesity and lifestyle changes can reduce blood pressure by 5 mmHg. Practices such as not smoking, physical activity (150 minutes per week), Mediterranean diet and alcohol restriction reduce the risk of HT by 50%. The World Health Organization emphasizes that regular physical activity is important in preventing death and disability. In a study in Turkey involving 15,468 adults, it was determined that only 3.5% of them do regular physical activity. According to the National Household Survey, 20.32% of individuals are sedentary and 15.99% do insufficient physical activity. Despite the abundance of information on the health benefits of physical activity, the question of why adults do not engage in enough physical activity is important. Research is insufficient for physical activity knowledge and behavior change in individuals. Physical activity increase interventions based on theories such as the Transtheoretical Model (TM) are effective for behavior change. TM includes elements such as stages of change, self-efficacy, and decision-making balance. The aim of this study was to investigate the effects of individual physical activity counseling based on the stage of change in physically inactive hypertensive individuals on physical activity levels and the perceived benefits and barriers of individuals' participation in physical activity.

Conditions

Hypertension; Physical Activity; Behavior Change

Keywords

hypertansion; physical activity; behavior change

Outcome Measures

Primary Outcomes (2)

• Physical Activity

  The long form of the International Physical Activity Questionnaire (IPAQ) will be used. The International Physical Activity Questionnaire - Long Form (IPAQ-LF) is a validated tool used to assess an individual's physical activity across various domains, including work, transport, domestic, and leisure-time activities. Physical activity levels are expressed in MET-minutes per week, where MET stands for Metabolic Equivalent of Task-a unit that estimates the energy expenditure of physical activities. One MET is defined as the energy cost of sitting quietly, equivalent to approximately 3.5 mL of oxygen consumption per kg of body weight per minute. Based on IPAQ scoring guidelines, total physical activity can range from a minimum of 0 MET-min/week (no reported activity) to a maximum of over 20,000 MET-min/week or more in highly active individuals. In this study, IPAQ-LF will be used to quantify participants' physical activity levels and categorize them as low, moderate, or high activity.

  through study completion, an average of 1 year

• Behavior Change

  The Stage of Change Identification Form will be used to determine the stage of behavioral change that individuals are in.

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Comorbidity

  through study completion, an average of 1 year

• Self care

  through study completion, an average of 1 year

Study Arms (2)

Stage-of-change based approach to behavior change

EXPERIMENTAL

Participants in the first group will have an individual physical activity program created within the scope of physical activity counseling on the first evaluation day. A 20-30 minute phone call will be made once a week by a psychologist regarding the stage of change they are in, and a 10-15 minute phone call will be made once a week by a physiotherapist for physical activity counseling.

Behavioral: Stage-of-change based physical activity counseling

Behavior change with brochure

ACTIVE COMPARATOR

The second group will be given a brochure with recommendations regarding physical activity and the benefits of physical activity for psychological health.

Behavioral: Giving the group a brochure with recommendations for physical activity and the benefits of physical activity for psychological health

Interventions

Stage-of-change based physical activity counseling BEHAVIORAL

On the first evaluation day, an individual physical activity program will be created for the participants in the group within the scope of physical activity counseling. A 20-30 minute phone call will be made once a week by a psychologist regarding the stage of change they are in, and a 10-15 minute phone call will be made once a week by a physiotherapist for physical activity counseling.

Stage-of-change based approach to behavior change

Giving the group a brochure with recommendations for physical activity and the benefits of physical activity for psychological health BEHAVIORAL

The second group will be given a brochure with recommendations for physical activity and the benefits of physical activity for psychological health.

Behavior change with brochure

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being between the ages of 18-60
• Not doing a minimum of 150 minutes/week of moderate intensity or 75 minutes/week of vigorous intensity physical activity
• Being willing to participate in the study,
• Not having problems reading and/or understanding the scales and being able to cooperate with the tests,
• Having stable and controlled hypertension.

You may not qualify if:

• Active infection,
• Having a musculoskeletal or neurological disease that may affect exercise performance, symptomatic heart disease,
• Having a neurological disease or other clinical diagnosis that may affect cognitive status,
• Having any orthopedic or neuromuscular disorder that will prevent walking or exercise performance,
• Having any chronic disease or having psychiatric disorders or mental disorders that may prevent cooperation.
• Being in the maintenance phase according to the change phase diagnosis form.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (1)

• Diaz-Gutierrez J, Ruiz-Estigarribia L, Bes-Rastrollo M, Ruiz-Canela M, Martin-Moreno JM, Martinez-Gonzalez MA. The role of lifestyle behaviour on the risk of hypertension in the SUN cohort: The hypertension preventive score. Prev Med. 2019 Jun;123:171-178. doi: 10.1016/j.ypmed.2019.03.026. Epub 2019 Mar 19.

  PMID: 30902699 BACKGROUND

MeSH Terms

Conditions

Hypertension; Motor Activity

Interventions

Exercise; Mental Health

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: July 16, 2025
• Study Start: March 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)