NCT06437756

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

May 27, 2024

Last Update Submit

July 2, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Hand Held Dynamometer

    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

    6 week

  • Modified BORG Scale

    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

    6 week

  • Chadler Fatigue Scale

    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

    6 week

  • 6 Min walk test (Distance in meters)

    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).

    6 week

  • The 30 Second Sit to Stand Test(30SSST) for lower limb strength

    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.

    6 week

Study Arms (2)

Theraband resistance training

EXPERIMENTAL
Other: Theraband resistance training

Conventional Resistance Training

ACTIVE COMPARATOR
Other: Conventional Resistance Training

Interventions

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.

Theraband resistance training

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.

Conventional Resistance Training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Nafees Medical Hospital

Islamabad, Federal, 44000, Pakistan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Muhammad Iqbal Tariq, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2024

First Posted

May 31, 2024

Study Start

May 1, 2024

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations