Comparison of the Effectiveness of Exercise and Vagus Therapy in Healthy Individuals

NCT04832347 | Unknown DMC

• 1 other identifier: VNS002
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Sympathetic activity starts to increase during exercise. At the end of the exercise, while sympathetic activation decreases, parasympathetic activity increases. Sympathetic and parasympathetic excursions achieve homeostasis. Most of the parasympathetic activity effects are vagus code. It is aimed to compare the comparison of exercise and vagus therapy in these healthy individuals.

Conditions

Healthy; Activity, Motor; Sleep; Stress, Physiological; Fatigue

Keywords

Exercise; Vagus therapy; Autonomic nervous system

Outcome Measures

Primary Outcomes (1)

• Evaluation of autonomous parameters

  Systolic / diastolic blood pressure (mmHg) will be measured with the Braun sphygmomanometer.

  Change from Systolic / diastolic blood pressure (mmHg) at 2 months.

Secondary Outcomes (4)

• Chest circumference measurement

  Change from a tape measure in the axillary, xiphoid and subcostal regions while at normal (cm) at 2 months, max inspiratory(cm) and max expiration(cm)

• Perceived Stress Scale

  Change of the scores obtained in the questionnaires at 2 months.

• Pitsburg Sleep Quality Scale

  Change of the scores obtained in the questionnaires at 2 months.

• Fatigue Severity Scale

  Change of the scores obtained in the questionnaires at 2 months.

Study Arms (3)

Exercise group

EXPERIMENTAL

Exercise group will be given stabilization exercises for a total of 24 sessions, 3 times a week for 8 weeks, each session for 45 minutes.

Other: Exercise

Vagus group

EXPERIMENTAL

Vagus therapy will be applied to Group 2 for 8 weeks, 3 times a week for a total of 24 sessions, each session for 30 minutes.

Other: Vagus Nerve Stimulation

Control group

NO INTERVENTION

Control group will be followed as a control group and no application will be made.

Interventions

Exercise OTHER

Exercise Group will be given stabilization exercises for a total of 24 sessions, 3 times a week for 8 weeks, each session for 45 minutes.

Exercise group

Vagus Nerve Stimulation OTHER

Vagus therapy will be applied for 8 weeks, 3 times a week for a total of 24 sessions, each session for 30 minutes.

Vagus group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteer individuals (Female and Male),
• Individuals between the ages of 18-50,
• Obtaining the necessary consent for the study,
• No trauma or surgery history in the last 6 months,
• Does not have any chronic disease (Obesity, Diabetes, Hypertension, Osteoporosis)

You may not qualify if:

• Individuals not wanting to continue working.
• Individuals having disability during the work process

Sponsors & Collaborators

• Sinop University: lead

Study Sites (1)

Sefa Haktan Hatık

Sinop, Turkeli, 57900, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Fatigue

Interventions

Exercise; Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, PT, MSc, PhD(c)

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 5, 2021
• Study Start: April 30, 2021
• Primary Completion: June 7, 2021
• Study Completion: July 7, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)