## Protocol Section
### Identification Module
**NCT ID:** NCT06427616

**Brief Title:** Moderate Intensity Soleus Pushups Versus Sustained Soleus Pushups on Blood Glucose Level Among Young Population

**Official Title:** Effects of Short Duration Moderate Intensity Soleus Pushups Versus Sustained Soleus Pushups on Blood Glucose Level Among Young Population

#### Organization Study ID Info
**ID:** 3547 Sara Noor
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-07-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-28

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-10-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Riphah International University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To determine that the short duration moderate intensity soleus push-ups will have a better effect on blood glucose level as compared to sustained soleus push-ups.

**Detailed Description:** The soleus muscle is a slow oxidative muscle which possesses molecular machinery necessary for regulating blood borne substrates. It has the ability to increase the local oxidative metabolism for a long period of time without experiencing fatigue. The uniqueness lies in this muscle because of its inability to store glycogen and derives its energy directly from the glucose present in the bloodstream. This in turn helps in lowering the blood sugar by using the excess blood glucose as its primary source of fuel. The soleus muscle also stands out because of its high composition of slow oxidative fibers, around 88% of the fibers are slow twitch fibers, making it the only muscle in human body containing greater proportion of slow twitch fiber.

A specific exercise called soleus push-ups (SPU) can have a huge impact on boosting metabolism and regulating blood glucose level better than the total body muscle exercises, intermittent fasting, weight loss etc. According to the previous study it showed a significant effect on the overall blood chemistry when performed for 270 mins.

So,the purpose of this study will be to find the comparison of acute effects of sustained soleus push-ups with moderate resisted soleus push-ups on blood sugar level. To find whether moderate resisted soleus push-ups will give same or better results in short period of time.

### Conditions Module

**Conditions:**

- Health Behavior

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 39

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Moderate intensity involving weighted soleus push-ups is performed till patient MHR is achieved.

**Intervention Names:**

- Behavioral: Short Duration Moderate Intensity Soleus Push-ups

**Label:** Short Duration Moderate Intensity Soleus Push-ups (Group A)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Sustained soleus push-ups will be performed for up to 270 min.

**Intervention Names:**

- Behavioral: Sustained Soleus Push-ups

**Label:** Sustained Soleus Push-ups (Group B)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Short Duration Moderate Intensity Soleus Push-ups (Group A)

**Description:** Participants will start soleus push-ups in sitting positions. To do so, the participants will be in a seated position, the legs will be at 90 degrees to the floor, feet will be placed flat on the ground. Participants will then move their heels up and down continuously.

Soleus push-ups will be performed with moderate intensity using weights which will be placed on their laps.

Participants will perform this activity till their 60-80% of their maximum heart rate is achieved and maintained

**Name:** Short Duration Moderate Intensity Soleus Push-ups

**Other Names:**

- Group A

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Sustained Soleus Push-ups (Group B)

**Description:** Participants will start soleus push-ups in sitting. To do so, the participants will be in a seated position, the legs will be at 90 degrees to the floor, and feet will be placed flat on the ground. Participants will then move their heels up and down continuously for.

Sustained soleus push-ups will be performed with light intensity for up to 270 mins.

No external resistance will be added. Participants will be provided with a maximum of 4 min break time after every 90 mins intervention. In the meantime, their blood sample will be collected

**Name:** Sustained Soleus Push-ups

**Other Names:**

- Group B

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** Adherence to the prescribed exercise will be monitored throughout the intervention period to assess compliance and determine if there are any differences in adherence between the two exercise groups.

**Measure:** Adherence to Exercise Protocol

**Time Frame:** Baseline to 6 hours

#### Primary Outcomes

**Description:** The primary outcome measure will be the change in blood sugar level, measured before and after the intervention period. This will provide insight into the direct impact of short duration moderate intensity soleus push-ups vs sustained soleus push-ups on blood sugar levels among young individuals.

**Measure:** Change in Blood Sugar Level

**Time Frame:** Baseline to 6 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age: 18-35 years.
* Gender: both male and female.
* Healthy young adults.
* BMI: healthy weight.

Exclusion Criteria:

* Patient with cardiac issues.
* Any neurological issues.
* Knee injuries.
* Patient with any lower limb injuries.
* DVT and lower amputation.
* Any known diabetic patient.

**Healthy Volunteers:** True

**Maximum Age:** 26 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** waqar.ahmed@riphah.edu.pk

**Name:** Waqar Ahmed Awan, PHD

**Phone:** 0333-534884

**Role:** CONTACT

**Contact 2:**

**Email:** saramoghal58@gmail.com

**Name:** Sara Noor, DPT

**Phone:** 0306-1515493

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rawalpindi

**Contacts:**

***Contact 1:***

- **Email:** waqar.ahmed@riphah.edu.pk

- **Name:** Waqar Ahmed Awan, PHD

- **Phone:** 03335348846

- **Role:** CONTACT

***Contact 2:***

- **Email:** saramoghal58@gmail.com

- **Name:** Sara Noor, Masters

- **Phone:** 03061515493

- **Role:** CONTACT

**Country:** Pakistan

**Facility:** Railway General Hospital

**State:** Punjab

**Status:** RECRUITING

**Zip:** 46120

#### Overall Officials

**Official 1:**

**Affiliation:** Riphah International University Islamabad

**Name:** Waqar Ahmed Awan, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
