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Completed

NCT Number: NCT06780878

Comparison of Progressive Muscle Relaxation and Stretching Exercises in Diabetic Population

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.

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Key information

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Progressive Muscle Relaxation Technique

Other

PMR focuses on the relationship between muscle tension and relaxation. By deliberately tensing a muscle group for a few seconds and then releasing the tension, individuals become more aware of the sensation of relaxation.

Group A Participants will receive PMR for 10 minutes each session, 3 sessions per week for 2 weeks and outcome measures will be recorded pre and post for each session.

Stretching exercises

Other

Stretching exercises are physical activities designed to improve the flexibility of muscles and joints. These exercises involve elongating specific muscle groups to enhance their elasticity and improve the range of motion around a joint.

Participants will be given 15 second stretches for each large muscle group, 3 sessions per week, for 2 weeks. Outcome measures will be assessed pre and post intervention.

Control Group

Other

This group will consist of 12 participants who will not be given any physical therapy interventions. Same measurements will be taken at same intervals as the experimental groups.

Primary outcomes

  1. Heart rate variability

    Time frame: 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.

  2. Cortisol levels

    Time frame: 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.

  3. Galvanic skin response

    Time frame: 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.

  4. Perceived stress

    Time frame: 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 Perceived Stress Scale (PSS) scoring involves summing the responses to 10 questions, with higher scores indicating higher perceived stress levels. The scale uses a 5-point Likert scale, where 0 represents "never" and 4 represents "very often". Some questions are reverse-scored to account for coping mechanisms. Scores can range from 0 to 40, with ranges like 0-13 (low), 14-26 (moderate), and 27-40 (high) used for general interpretation

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparison of Progressive Muscle Relaxation and Stretching Exercises Mediated by Stress in Diabetic Population

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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