Congestive Heart FailureNCT07440914
Exercise-based Cardiac Rehabilitation in Congestive Heart Failure With Coexisting Knee Osteoarthritis
A study testing Exercise Based Cardiac Rehabilitation in people with Congestive Heart Failure, run by Riphah International University at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Exercise Based Cardiac Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jul 2024to 17 Aug 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
1. Behria International Hospital 2. Punjab Institute of Cardiology
Lahore, Punjab Province, 42000
About this study
Official title: Effects of Exercise-based Cardiac Rehabilitation in Patient With Congestive Heart Failure and 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
- Conditions
- Congestive Heart Failure
- Being tested
- Exercise Based Cardiac Rehabilitation, Controlled Group
- Keywords
- Exercised-based cardiac rehabilitation, Congestive heart failure, knee osteoarthritis, low impact aerobic exercise, strength exercises
- Medical subject headings
- Heart Failure, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Based Cardiac RehabilitationOther
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 GroupOther
Education and Counseling consisting of Regular sessions on disease education, self-management strategies, nutrition, and adherence to medication.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Other | Not described Receives: Other: Exercise Based Cardiac Rehabilitation |
| Controlled Group | Other | Not described Receives: Other: Controlled Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 MWT functional capacity
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
Measured: 8 weeks
ECHO (left ventricle Ejection fraction)
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
Measured: 8 weeks
WOMAC Questionnaire
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start30 Jul 2024
- Primary completion30 Jun 2025
- Study completion17 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MUHAMMAD USAMA IQBAL, MS-PT(CPPT), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440914
- Sponsor's protocol ID
- REC/RCR/&AHS/24/0325
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamiya K, Sato Y, Takahashi T, Tsuchihashi-Makaya M, Kotooka N, Ikegame T, Takura T, Yamamoto T, Nagayama M, Goto Y, Makita S, Isobe M. Multidisciplinary Cardiac Rehabilitation and Long-Term Prognosis in Patients With Heart Failure. Circ Heart Fail. 2020 Oct;13(10):e006798. doi: 10.1161/CIRCHEARTFAILURE.119.006798. Epub 2020 Sep 28.
PubMed 32986957Cattadori G, Segurini C, Picozzi A, Padeletti L, Anza C. Exercise and heart failure: an update. ESC Heart Fail. 2018 Apr;5(2):222-232. doi: 10.1002/ehf2.12225. Epub 2017 Dec 13.
PubMed 29235244Tegegne TK, Rawstorn JC, Nourse RA, Kibret KT, Ahmed KY, Maddison R. Effects of exercise-based cardiac rehabilitation delivery modes on exercise capacity and health-related quality of life in heart failure: a systematic review and network meta-analysis. Open Heart. 2022 Jun;9(1):e001949. doi: 10.1136/openhrt-2021-001949.
PubMed 35680170Xie SH, Wang Q, Wang LQ, Zhu SY, Li Y, He CQ. The feasibility and effectiveness of internet-based rehabilitation for patients with knee osteoarthritis: A study protocol of randomized controlled trial in the community setting. Medicine (Baltimore). 2020 Oct 30;99(44):e22961. doi: 10.1097/MD.0000000000022961.
PubMed 33126366Paneroni M, Scalvini S, Corra U, Lovagnini M, Maestri R, Mazza A, Raimondo R, Agostoni P, La Rovere MT. The Impact of Cardiac Rehabilitation on Activities of Daily Life in Elderly Patients With Heart Failure. Front Physiol. 2022 Jan 5;12:785501. doi: 10.3389/fphys.2021.785501. eCollection 2021.
PubMed 35069247King LK, Marshall DA, Jones CA, Woodhouse LJ, Ravi B, Faris PD, Hawker GA; BEST-Knee Team. Are medical comorbidities contributing to the use of opioid analgesics in patients with knee osteoarthritis? Osteoarthritis Cartilage. 2020 Aug;28(8):1030-1037. doi: 10.1016/j.joca.2020.04.012. Epub 2020 May 7.
PubMed 32387761Edelmann F, Wachter R, Duvinage A, Mueller S, Fegers-Wustrow I, Schwarz S, Christle JW, Pieske-Kraigher E, Seyfarth M, Knapp M, Dorr M, Nolte K, Dungen HD, Herrmann-Lingen C, Esefeld K, Hagendorff A, Haykowsky MJ, Hasenfuss G, Holzendorf V, Prettin C, Mende M, Pieske B, Halle M. Combined endurance and resistance exercise training in heart failure with preserved ejection fraction: a randomized controlled trial. Nat Med. 2025 Jan;31(1):306-314. doi: 10.1038/s41591-024-03342-7. Epub 2025 Jan 2.
PubMed 39747684
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise-based Cardiac Rehabilitation in Patient With Congestive Heart Failure and Coexisting Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07440914
- Acronym / sponsor ID
- REC/RCR/&AHS/24/0325
- Conditions
- Congestive Heart Failure
- Keywords
- Exercised-based cardiac rehabilitation, Congestive heart failure, knee osteoarthritis, low impact aerobic exercise, strength exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 17 Aug 2025 (actual)
- First posted
- 27 Feb 2026 (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.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Other | Other: Exercise Based Cardiac Rehabilitation |
| Controlled Group | Other | Other: Controlled Group |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Exercise Based Cardiac RehabilitationExercise 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 | Other | Intervention Group |
| Controlled GroupEducation and Counseling consisting of Regular sessions on disease education, self-management strategies, nutrition, and adherence to medication. | Other | Controlled Group |
Primary outcome
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
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
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
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 27 Feb 2026.
- Background: PubMed 32986957Kamiya K, Sato Y, Takahashi T, Tsuchihashi-Makaya M, Kotooka N, Ikegame T, Takura T, Yamamoto T, Nagayama M, Goto Y, Makita S, Isobe M. Multidisciplinary Cardiac Rehabilitation and Long-Term Prognosis in Patients With Heart Failure. Circ Heart Fail. 2020 Oct;13(10):e006798. doi: 10.1161/CIRCHEARTFAILURE.119.006798. Epub 2020 Sep 28.
- Background: PubMed 29235244Cattadori G, Segurini C, Picozzi A, Padeletti L, Anza C. Exercise and heart failure: an update. ESC Heart Fail. 2018 Apr;5(2):222-232. doi: 10.1002/ehf2.12225. Epub 2017 Dec 13.
- Background: PubMed 35680170Tegegne TK, Rawstorn JC, Nourse RA, Kibret KT, Ahmed KY, Maddison R. Effects of exercise-based cardiac rehabilitation delivery modes on exercise capacity and health-related quality of life in heart failure: a systematic review and network meta-analysis. Open Heart. 2022 Jun;9(1):e001949. doi: 10.1136/openhrt-2021-001949.
- Background: PubMed 33126366Xie SH, Wang Q, Wang LQ, Zhu SY, Li Y, He CQ. The feasibility and effectiveness of internet-based rehabilitation for patients with knee osteoarthritis: A study protocol of randomized controlled trial in the community setting. Medicine (Baltimore). 2020 Oct 30;99(44):e22961. doi: 10.1097/MD.0000000000022961.
- Background: PubMed 35069247Paneroni M, Scalvini S, Corra U, Lovagnini M, Maestri R, Mazza A, Raimondo R, Agostoni P, La Rovere MT. The Impact of Cardiac Rehabilitation on Activities of Daily Life in Elderly Patients With Heart Failure. Front Physiol. 2022 Jan 5;12:785501. doi: 10.3389/fphys.2021.785501. eCollection 2021.
- Background: PubMed 32387761King LK, Marshall DA, Jones CA, Woodhouse LJ, Ravi B, Faris PD, Hawker GA; BEST-Knee Team. Are medical comorbidities contributing to the use of opioid analgesics in patients with knee osteoarthritis? Osteoarthritis Cartilage. 2020 Aug;28(8):1030-1037. doi: 10.1016/j.joca.2020.04.012. Epub 2020 May 7.
- Background: PubMed 39747684Edelmann F, Wachter R, Duvinage A, Mueller S, Fegers-Wustrow I, Schwarz S, Christle JW, Pieske-Kraigher E, Seyfarth M, Knapp M, Dorr M, Nolte K, Dungen HD, Herrmann-Lingen C, Esefeld K, Hagendorff A, Haykowsky MJ, Hasenfuss G, Holzendorf V, Prettin C, Mende M, Pieske B, Halle M. Combined endurance and resistance exercise training in heart failure with preserved ejection fraction: a randomized controlled trial. Nat Med. 2025 Jan;31(1):306-314. doi: 10.1038/s41591-024-03342-7. Epub 2025 Jan 2.
- Individual participant dataSharing planned: No
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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.
MUHAMMAD USAMA IQBAL, MS-PT(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 Exercise Based Cardiac Rehabilitation in people with Congestive Heart Failure, 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 7 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 27 Feb 2026. 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?
6 MWT functional capacity (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07440914, which also lists 7 linked publications.
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 27 Feb 2026.