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NCT Number: NCT07440914

Exercise-based Cardiac Rehabilitation in Congestive Heart Failure With Coexisting Knee Osteoarthritis

Exercise-based cardiac rehabilitation (CR) has been shown to significantly improve cardiovascular health and overall well-being in patients with congestive heart failure (CHF). However, a substantial number of CHF patients also suffer from comorbid conditions, such as knee osteoarthritis (OA), which can impede their ability to engage in physical activity and, consequently, derive full benefits from CR. Knee OA is characterized by pain, stiffness, and reduced joint mobility, which can significantly limit exercise capacity and adherence to CR programs. This dual burden poses a unique challenge, necessitating tailored rehabilitation approaches that accommodate both cardiovascular and musculoskeletal limitations. This study aims to evaluate the effectiveness of an exercise-based CR program specifically adapted for patients with CHF and coexisting knee OA, focusing on improvements in cardiovascular function, joint mobility, pain management, and overall quality of life.

This study will employ a randomized controlled trial (RCT) design involving 100 patients diagnosed with both CHF and knee OA. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will undergo a 12-week exercise-based CR program tailored to accommodate their knee OA, incorporating low-impact aerobic exercises, strength training, and flexibility exercises specifically designed to minimize knee joint stress. The control group will receive standard medical care without the structured exercise program. Primary outcomes will include changes in cardiovascular fitness, assessed by peak oxygen uptake (VO2 peak), and knee function, measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcomes will assess pain levels, quality of life using the SF-36 questionnaire, and adherence rates to the rehabilitation program. Data will be collected at baseline, post-intervention (12 weeks), and at a 6-month follow-up to evaluate both immediate and long-term effects. Statistical analyses will be conducted to compare the outcomes between the two groups and determine the efficacy of the tailored CR program.

Keywords: Exercised-based cardiac rehabilitation, Congestive heart failure, knee osteoarthritis, low impact aerobic exercise, strength training

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Key information

Conditions

Congestive Heart Failure Arthritis Cardiovascular Diseases Heart Diseases Heart Failure Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

1. Behria International Hospital 2. Punjab Institute of Cardiology

Lahore, Punjab Province, 42000, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a confirmed diagnosis of CHF, classified according to the New York Heart Association (NYHA) functional classification II-III.
  • Radiographically confirmed diagnosis of knee OA, based on the Kellgren-Lawrence grading system (grade II-III).
  • Adults aged 40-80 years
  • Left ventricular ejection fraction (LVEF) ≤ 40% as measured by echocardiography within the last 6 months.
  • Patients must be on stable pharmacologic therapy for CHF for at least 4 weeks prior to enrollment.

Exclusion criteria

  • Presence of severe comorbid conditions that could interfere with the study protocol or pose a risk to the patient, such as severe pulmonary disease, advanced renal or liver disease, or active malignancy.
  • Kellgren-Lawrence grade IV knee OA or recent knee surgery within the last 6 months.
  • Presence of inflammatory arthritis, such as rheumatoid arthritis or gout
  • Recent myocardial infarction (within the past 3 months), unstable angina, or recent coronary artery bypass graft surgery.
  • Any condition that contraindicates exercise participation, such as severe hypertension (BP > 180/110 mmHg), uncontrolled arrhythmias, or severe aortic stenosis.
  • Significant cognitive impairment or psychiatric disorder that would interfere with adherence to the exercise protocol.
  • Patients already participating in regular, structured exercise programs exceeding moderate intensity (>150 minutes per week)

Treatment and study plan

Exercise Based Cardiac Rehabilitation

Other

Exercise Prescription:

Aerobic Exercise: walking, stationary cycling, Resistance / strength training, Flxibility and Range of motion, Balance and proprioception

Strength Training: Lower limb strengthening focus: Quadriceps, Hamstrings, Gluteals Upper body Shoulders, Arms (light resistance) Exercises using Thera Bands, light dumbbells, or body weight Isometric exercises initially if active movement is painful

Type: Resistance exercises focusing on major muscle groups, especially lower extremities to support knee function,e.g. Quadriceps, Hamstrings, Gluteal muscles, Hip adductors, abductors and Calf muscles using weights, resistance bands, or machines.

Flexibility and Balance Exercises: Static stretching of major lower limb muscle groups:

Quadriceps, Hamstrings, Calf muscles, Hip flexors, Gentle knee range of motion exercises within pain-free limits

Controlled Group

Other

Education and Counseling consisting of Regular sessions on disease education, self-management strategies, nutrition, and adherence to medication.

Primary outcomes

  1. 6 MWT functional capacity

    Time frame: 8 weeks

    The 6-minute walk test (6MWT) serves as a valuable and widely used data collection tool in research, particularly in studies assessing functional capacity, exercise tolerance, and overall physical performance. it was used to collect data pre-post exercise

  2. ECHO (left ventricle Ejection fraction)

    Time frame: 8 weeks

    Left Ventricular Ejection Fraction (LVEF) is a key measurement used in echocardiography (ECHO) to assess the heart's function, particularly its ability to pump blood. LVEF represents the percentage of blood that is ejected from the left ventricle (the heart's main pumping chamber) with each heartbeat. pre-post data was collected

  3. WOMAC Questionnaire

    Time frame: 8 weeks

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, validated questionnaire designed to evaluate the condition of patients with osteoarthritis (OA) of the knee and hip. Developed in the 1980s, the WOMAC is specifically tailored to measure three key dimensions: pain, stiffness, and physical function. The questionnaire comprises 24 items divided into three subscales: 5 items for pain, 2 items for stiffness, and 17 items for physical function. pre-post data was collected

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Exercise-based Cardiac Rehabilitation in Patient With Congestive Heart Failure and Coexisting Knee Osteoarthritis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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