Effect of Breathing and Relaxation Exercises on Serum Cortisol Levels in Type 2 Diabetic Patients

NCT05231031 | Completed DMC

• 1 other identifier: DM and Cortisol
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Diabetes is a fast-growing health problem in Egypt with a significant impact on morbidity, mortality, and health care resources. Aim of the study: To assess the effect of breathing and relaxation exercises on serum cortisol levels in type 2 diabetic patients. Subject and Methods: sixty, type 2 diabetic patients for more than 5 years were selected from the outpatient clinic of the Faculty of Physical Therapy, Cairo University. Their age ranged from 40 to 50 years. Serum cortisol and blood glucose tests were done before the start of the study and after 6 weeks. The patients were randomly assigned into two equal groups in number (30 patients for each group) performed 3 sessions/week for 6 weeks. Group A received aerobic exercise in the form of walking on a treadmill, breathing exercise, and mindfulness meditation, and group B received continuous aerobic exercise only in the form of walking on a treadmill. ( The exercise program included 45 minutes and consist of warming up phase of slow walking on the treadmill for 5 minutes, training phase 35 minutes, and cooling down for 5 minutes) .

Conditions

Diabetes Mellitus; Stress

Outcome Measures

Primary Outcomes (2)

• Fating blood glucose

  blood sampling for blood glucose after 9 hours fasting

  6 weeks

• Serum cortisol level

  blood sampling for cortisol at 8 am

  6 weeks

Secondary Outcomes (1)

• The perceived stress score (PSS)

  6 weeks

Study Arms (2)

Aerobic exercise

ACTIVE COMPARATOR

This group received continuous aerobic exercise only in the form of walking on a treadmill 3 sessions/week for 6 weeks

Behavioral: Aerobic exercise

Aerobic, Breathing exercises , and relaxation training

EXPERIMENTAL

This group received continuous aerobic exercise only in the form of walking on a treadmill 3 sessions/week for 6 weeks in addition to breathing exercises and relaxation training for the same period

Behavioral: Aerobic exercise; Behavioral: breathing exercise; Behavioral: Relaxation training

Interventions

Aerobic exercise BEHAVIORAL

continuous aerobic exercise on a treadmill

Aerobic exercise; Aerobic, Breathing exercises , and relaxation training

breathing exercise BEHAVIORAL

continuous aerobic exercise plus breathing exercise (Mindfulness)

Aerobic, Breathing exercises , and relaxation training

Relaxation training BEHAVIORAL

continuous aerobic exercise plus relaxation training

Aerobic, Breathing exercises , and relaxation training

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sixty diabetic patients (29 women and 31 men), their age between 45 and 65 years .
• They had type 2 diabetes mellitus for more than 5years.
• Their HbA1c value from 6.5% to 7.5%.
• Stress scores on the Perceived stress scale are \>13 in the eligibility check assessment.
• All patients are under full medical supervision.
• Their physical activity level is less than 30 minutes of aerobic training in the week.
• Their body mass index ranged from 25 to 34.9. (overweight and obesity class I).

You may not qualify if:

• Any patient is known to have an unstable medical condition and sleeping disorder.
• Indication of receiving treatments for depression and anxiety.
• Musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise.
• Cushing's disease (hypercortisolism) or Addison's disease (hypocortisolism).
• Hepatic diseases and dyslipidemia.
• Patients with renal and vascular diseases.
• Severe hypertensive patients (higher than 200/120 mmHg).
• Any acute or chronic inflammatory disorder.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Alkasr Alaini hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Exercise; Breathing Exercises; Relaxation Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hady Atef, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy

Study Record Dates

• First Submitted: January 16, 2022
• First Posted: February 9, 2022
• Study Start: January 1, 2021
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months
• Access Criteria: will upload it to the journal of publication

Locations

EG (1)