Diabetes Mellitus Type 2NCT06780878
Comparison of Progressive Muscle Relaxation and Stretching Exercises in Diabetic Population
A study testing Progressive muscle relaxation technique and Stretching exercises in people with Diabetes Mellitus Type 2, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Progressive muscle relaxation technique and Stretching exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 35-65 years
- Females
- Uncontrolled Diabetes Mellitus
- Sedentary Lifestyle
- Has never undergone progressive muscular relaxation before.
Who cannot join
- Unstable Angina
- Cardiac arrhythmia
- Postural deformities
- Left ventricular ejection fraction < 45%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Progressive Muscle Relaxation and Stretching Exercises Mediated by Stress 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.
Read more
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.
Read the 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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Progressive muscle relaxation technique, Stretching exercises, Control Group
- Keywords
- perceived stress, progressive muscle relaxation, stretching exercises, heart rate variability, cortisol levels, galvanic skin response
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive muscle relaxation techniqueOther
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 exercisesOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Feb 2025
- Primary completion30 Apr 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of 2 active comparators and 1 control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Naeem, DPT, MS-CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780878
- Sponsor's protocol ID
- Rana Ghunwa Tanveer
- Status last verified
- Aug 2025
- First submitted
- 13 Jan 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Progressive Muscle Relaxation and Stretching Exercises Mediated by Stress in Diabetic Population
- ClinicalTrials.gov ID
- NCT06780878
- Acronym / sponsor ID
- Rana Ghunwa Tanveer
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- perceived stress, progressive muscle relaxation, stretching exercises, heart rate variability, cortisol levels, galvanic skin response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The study consists of 2 active comparators and 1 control group.
| Arm | Type | Receives |
|---|---|---|
| Progressive muscle relaxation technique | Experimental | Other: Progressive muscle relaxation techniqueThis 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. |
| Stretching exercises | Experimental | Other: Stretching exercisesThis 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. |
| Control group | Other | Other: Control GroupThis 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 35-65 years
- Females
- Uncontrolled Diabetes Mellitus
- Sedentary Lifestyle
- Has never undergone progressive muscular relaxation before.
Key exclusion criteria (4 listed)
- Unstable Angina
- Cardiac arrhythmia
- Postural deformities
- Left ventricular ejection fraction < 45%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive muscle relaxation techniquePMR 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. | Other | Progressive muscle relaxation technique |
| Stretching exercisesStretching 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. | Other | Stretching exercises |
| Control GroupThis 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 |
Primary outcome
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Naeem, DPT, MS-CPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive muscle relaxation technique and Stretching exercises in people with Diabetes Mellitus Type 2, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.