## Protocol Section
### Identification Module
**NCT ID:** NCT06437756

**Brief Title:** Effects of Theraband Resistance Training on Muscle Strength in Coronary Artery Diseases

**Official Title:** Effects of Theraband Resistance Training on Muscle Strength in Coronary Artery Diseases

#### Organization Study ID Info
**ID:** REC/01808 Zunaira Shaukat
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-07-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### 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:** True

### Description Module

**Brief Summary:** To compare the effects of Theraband Resistance Training with Conventional Resistance Training on muscle strength in coronary artery diseases

### Conditions Module

**Conditions:**

- Coronary Artery Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 38

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Theraband resistance training

**Label:** Theraband resistance training

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Conventional Resistance Training

**Label:** Conventional Resistance Training

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Theraband resistance training

**Description:** Three sessions of 30 minutes each was used to complete the intervention over the course of six weeks (two sets of 12 repetitions). The participants were warmed up by stretching for 10 minutes before each session Participants were advised to take 5 mins rest before moving to next movement if they would feel fatigued after one movement. Thera-Band was utilized in only three different colors for the workouts.

**Name:** Theraband resistance training

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Conventional Resistance Training

**Description:** The intervention was carried out over the course of six weeks in three sessions of 30 minutes each (two sets of 12 repetitions). The participants were warmed up by stretching for 10 minutes before each session. The resistance-training program was performed with Universal weights.

**Name:** Conventional Resistance Training

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** If testing techniques are consistent, handheld dynamometry is a valid approach to assess the strength state and change in strength status. Hand-held dynamometry can be a reliable assessment technique when practiced by a single experienced tester

**Measure:** Hand Held Dynamometer

**Time Frame:** 6 week

**Description:** The Modified Borg Dyspnea Scale is numerical rating scale ranging from 0 to 10 and is used to measure dyspnea that patient report during sub-maximal exercise and is regularly administered during six-minute walk test. Changes from the baseline will be measured

**Measure:** Modified BORG Scale

**Time Frame:** 6 week

**Description:** It is a self-administered questionnaire for assessing the degree and severity of fatigue/tiredness in epidemiological populations, both clinical and non-clinical. The Chadler Fatigue Scale (CFS) was originally perceived as comprising two subscales that evaluate fatigue in the physical and mental domains. Items are rated on a 4-point Likert scale (0 = better than usual, 1 = no more than usual, 2 = worse than usual, 3 = much worse than usual), with higher scores indicating greater fatigue. Changes from the baseline are measured

**Measure:** Chadler Fatigue Scale

**Time Frame:** 6 week

**Description:** Changes from the baseline, Body Mass Index can be define as statistical index utilizing an individuals height and weight to give an estimation of muscle versus fat in female and male of all ages. It is determined by taking an individual weight in kilograms, separated by their height in meters squared, or BMI = weight (in kg)/height (in m square).

**Measure:** 6 Min walk test (Distance in meters)

**Time Frame:** 6 week

**Description:** The 30-Second Sit to Stand Test evaluates older people's leg strength and endurance using a foldable chair without arms. Participants stand with feet positioned back from knees, arms crossed, and arms crossed. The examiner counts stand within 30 seconds, determining the score.

**Measure:** The 30 Second Sit to Stand Test(30SSST) for lower limb strength

**Time Frame:** 6 week

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participants having a documented diagnosis of CAD, confirmed by a medical professional.
* Individuals with a history of myocardial infarction (heart attack), angina, or evidence of significant coronary artery stenosis.
* Stable CAD who were not experiencing acute coronary events, such as recent heart attacks or unstable angina.
* Patients who were able to perform exercises with TheraBand.
* Reduced muscle strength of upper limb/lower limb

Exclusion Criteria:

* Patients over the age of 75 years.
* Exclude individuals with a recent history of Theraband resistance training.
* Severe cardiovascular complications such as heart failure with reduced ejection fraction, severe arrhythmias, or uncontrolled hypertension.
* Patients with unstable conditions or cardiac episodes.
* Individuals who had undergone major cardiovascular surgery (e.g., coronary artery bypass grafting) within the last six months.
* Ejection fraction \< 40%

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** iqbal.tariq@riphah.edu.pk

**Name:** Muhammad Iqbal Tariq, PhD*

**Phone:** 03338236752

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Islamabad

**Contacts:**

***Contact 1:***

- **Email:** iqbal.tariq@riphah.edu.pk

- **Name:** Muhammad Iqbal Tariq, PhD*

- **Phone:** 03338236752

- **Role:** CONTACT

***Contact 2:***

- **Name:** Zunaira Shaukat

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Pakistan

**Facility:** Al Nafees Medical Hospital

**State:** Federal

**Status:** RECRUITING

**Zip:** 44000

#### Overall Officials

**Official 1:**

**Affiliation:** Riphah International University

**Name:** Muhammad Iqbal Tariq, PhD*

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M6549

- Name: Coronary Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000003327

- Term: Coronary Disease

### Misc Info Module

- Version Holder: 2024-05-31
