Comparison of Progressive Muscle Relaxation and Stretching Exercises in Diabetic Population

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus Type 2

• Registration Number: NCT06780878
• Lead Sponsor: Riphah International University

Brief Summary

The goal of this clinical trial is to compare the effects of Progressive muscle relaxation and stretching exercises mediated by stress on heart rate variability, cortisol level, galvanic skin response and perceived stress scale. The main questions it aims to answer are, Will there be a significant difference between the effects of Progressive muscle relaxation and stretching exercises in the diabetic population? Can stress mediate the effects of Progressive muscle relaxation and stretching exercises in the diabetic population?

Researchers will compare the effects of Progressive muscle relaxation and stretching exercises mediated by stress on heart rate variability, cortisol level, galvanic skin response and perceived stress scale.

Participants will:

Be given session of Progressive muscle relaxation or stretching exercises or no physical therapy treatment 3 sessions per week for 2 weeks and visit the clinic once every 3 days for 2 weeks for intervention. Measurements will be taken before and after every session. Perceived Stress will be assessed at the start of the intervention at baseline and then after 2 weeks.

Detailed Description

The subject of this research is individuals with type 2 diabetes who also experience depression. Progressive muscle relaxation (PMR) has the potential to reduce blood sugar levels in type 2 diabetes patients. This reduction is linked to the stress, both physical and psychological, experienced by the patients.

When stressors are assessed, muscle tension is created, which signals the brain and creates a feedback. PMR works to interrupt this loop by stimulating the parasympathetic nervous system and influencing the hypothalamus through focused concentration, promoting a positive mindset and reducing stress on the hypothalamus. Stretching can also be easily integrated into a diabetic's daily routine promoting both physical and mental wellbeing.

Most studies focus on PMR or stretching exercises separately in managing stress, but comparing these two interventions in terms of stress reduction and physical outcomes in diabetics is limited.

Understanding which intervention provides better stress relief could lead to more targeted recommendations in diabetic care.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Study Start: 2025-02-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• Age 35-65 years Females Uncontrolled Diabetes Mellitus Sedentary Lifestyle Has never undergone progressive muscular relaxation before.

Exclusion Criteria

• Unstable Angina Cardiac arrhythmia Postural deformities Left ventricular ejection fraction < 45%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Heart rate variability	24 hours	It is a valuable tool in various fields, including health, fitness, and psychology for assessing the body's physiological responses. HRV is linked to emotional regulation and mental health, lower HRV is often associated with anxiety, depression, and other mental health conditions. In therapeutic settings, biofeedback using HRV can help individuals learn to manage stress and improve emotional resilience. HRV has been validated as a tool to measure autonomic nervous system activity, particularly the balance between sympathetic(stress) and parasympathetic (recovery) responses it is widely used in stress and fatigue research. HRV shows good test-retest reliability when measured under consistent conditions, such as in the same environment at the same time, of the day, and in the same position.
Cortisol levels	24 hours	Cortisol is a hormone released in response to stress, typically measured through saliva or blood samples. CL is used to monitor how well a patient is responding to treatment for conditions like adrenal disorders depression, or stress related illness. It can be measured through saliva, blood, urine, and hair being a common non-invasive method. Cortisol is widely regarded as a valid indicator of physiological stress. Cortisol is sensitive to external factors including stressors like physical exertion or even the experience of being tested. The reliability of cortisol as a measure of stress or health depends heavily on stress control.
Galvanic skin response	24 hours	GSR also known as electro-dermal activity, is a physiological measure of skin conductance that reflects changes in sweat gland activity. GSR measures the skin's ability to conduct electricity. When a person experiences emotional arousal, the (SNS triggers sweat glands, particularly on the palms and soles to become more active, this increases the skin's electrical conductance which the GSR sensor can detect. GSR is generally considered valid in measuring arousal or emotional intensity It is a good indicator of stress, anxiety, or excitement because these emotions typically involve a heightened autonomic nervous system.
Perceived stress	2 weeks	Perceived stress scale is a widely used psychological instrument designed to assess the perception of stress. It helps to measure the degree to which situations in one's life are appraised as stressful. It evaluates the subjective experience of stress. Which can vary significantly between individuals. Studies have confirmed that the PSS effectively measures perceived stress, a psychological state characterized by feelings of unpredictability and uncontrollability. The PSS has shown moderate test-retest reliability. Studies report test-retest correlations over several weeks ranging from 0.55 to 0.85, depending on the time frame.

Trial Locations

Locations (1)

Pakistan Railway General Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan