Comparison of Progressive Muscle Relaxation and Stretching Exercises in Diabetic Population

NCT06780878 | Completed DMC

• 1 other identifier: Rana Ghunwa Tanveer
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 2

Keywords

perceived stress; progressive muscle relaxation; stretching exercises; heart rate variability; cortisol levels; galvanic skin response

Outcome Measures

Primary Outcomes (4)

• Heart rate variability

  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.

  24 hours

• Cortisol levels

  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.

  24 hours

• Galvanic skin response

  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.

  24 hours

• Perceived stress

  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

  2 weeks

Study Arms (3)

Progressive muscle relaxation technique

EXPERIMENTAL

This group will consist of 12 female participants of age 35-65 years with Diabetes Mellitus type 2. This group will be given PMR, 10 minutes per session, 3 sessions per week for 2 weeks. Blood pressure (BP,) Blood sugar random (BSR), Oxygen saturation (SPO2), Heart rate (HR), Heart rate variability (HRV), Galvanic skin response (GSR), and Cortisol levels (CL) will be measured before and after every session. Perceived Stress Scale will be used to assess participants' stress levels at baseline and then after 2 weeks.

Other: Progressive muscle relaxation technique

Stretching exercises

EXPERIMENTAL

This group will consist of 12 female participants of age 35-65 years with Diabetes Mellitus type 2. Participants will be given stretching exercises, 10 minutes per session, 3 sessions per week for 2 weeks. Blood pressure (BP,) Blood sugar random (BSR), Oxygen saturation (SPO2), Heart rate (HR), Heart rate variability (HRV), Galvanic skin response (GSR), and Cortisol levels (CL) will be measured before and after every session. Perceived Stress Scale will be used to assess participants' stress levels at baseline and then after 2 weeks.

Other: Stretching exercises

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.

Other: Control Group

Interventions

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.

Progressive muscle relaxation technique

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.

Stretching exercises

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.

Control group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Gender Eligibility Details: Females are eligible to participate in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Muscle Stretching Exercises; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Maria Naeem, DPT, MS-CPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study consists of 2 active comparators and 1 control group.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: February 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)