Comparison of Progressive Muscle Relaxation and Stretching Exercises in Diabetic Population

NCT ID: NCT06780878

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study consists of 2 active comparators and 1 control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Progressive muscle relaxation technique

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.

Group Type EXPERIMENTAL

Progressive muscle relaxation technique

Intervention Type 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

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.

Group Type EXPERIMENTAL

Stretching exercises

Intervention Type 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

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.

Group Type OTHER

Control Group

Intervention Type 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.

Interventions

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Progressive muscle relaxation technique

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.

Intervention Type OTHER

Stretching exercises

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.

Intervention Type OTHER

Control Group

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.

Intervention Type OTHER

Eligibility Criteria

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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%
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Naeem, DPT, MS-CPPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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Rana Ghunwa Tanveer

Identifier Type: -

Identifier Source: org_study_id

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