Heart FailureNCT07062900
Low Intensity Physical Activity in Congestive Heart Failure Patients Among Different BMI
A study testing Low-Intensity Physical Activity in people with Heart Failure, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study examined the effects of low-intensity physical activity on functional capacity, quality of life, and psychological well-being in congestive heart failure patients with varying BMI. Forty patients were divided into intervention and control groups. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Low-Intensity Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Jul 2025to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized Congestive heart failure patients
- Age 45-70
- Diagnosed with CHF
- BMI all ranges
- Severely underweight: BMI<16 kg/m2
- Underweight: BMI≥ 16 kg/m2 and <18.5 kg/m2
Show all 10Show fewer
- Normal weight BMI≥18.5 kg/mg2 and <25kg/m2
- Overweight: BMI ≥25kg/m2 and<30 kg/m2
- Obese: BMI≥30 kg/m2
- Willing to participate in physical activity program
Who cannot join
- Musculoskeletal or neurological disorders
- Severe COPD or other respiratory diseases
- Cognitive impairment
- Cardiac catheter related surgery, valvular surgery within past 6 month
- Recent Lung embolis
- Lung cancer
- Participants in other clinical trial or intervention study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Arjumand
Lahore, Punjab Province, 40100
Arjumand Bano, MS-CPPT, 03059551883, arjumand.bano@riphah.edu.pk
MASOOM SAKINA, MS-CPPT
About this study
Official title: Effects of Low Intensity Physical Activity on Functional Capacity Quality of Life and Psychological Well Being in Congestive Heart Failure Patients Among Different BMI
This study examined the effects of low-intensity physical activity on functional capacity, quality of life, and psychological well-being in congestive heart failure patients with varying BMI. Forty patients were divided into intervention and control groups. The intervention group followed an 8-week physical activity program, while the control group received usual care. Results showed significant improvement in walk distance, quality of life, and depression scores in the intervention group. The study concludes that low-intensity physical activity effectively improves health outcomes in heart failure patients across different BMI categories.
Read the detailed description
This randomized controlled trial explored the effects of low-intensity physical activity on functional capacity, quality of life, and psychological well-being in patients with congestive heart failure across different BMI categories. A total of forty patients were selected and randomly assigned to either an intervention group or a control group. The intervention group participated in an eight-week structured low-intensity physical activity program, while the control group continued with usual care without additional physical activity. Various assessment tools were used to evaluate outcomes, including the 6-minute walk test to measure functional capacity, the Kansas City Cardiomyopathy Questionnaire to assess quality of life, and the Hospital Anxiety and Depression Scale to evaluate psychological well-being. The results demonstrated that although both groups showed some improvement, the intervention group experienced significantly greater gains in all measured outcomes. The 6-minute walk distance increased, KCCQ-12 scores improved notably, and depressive symptoms reduced significantly in the intervention group compared to the control. The study concluded that low-intensity physical activity is an effective and feasible intervention to enhance physical and mental health in congestive heart failure patients, irrespective of their BMI category.
- Conditions
- Heart Failure
- Being tested
- Low-Intensity Physical Activity, usual care
- Keywords
- Congestive Heart Failure, low intensity Physical Activity, functional capacity, quality of life, psychological well-being, Body Mass Index.
- Medical subject headings
- Heart Failure, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Physical ActivityBehavioural
This includes a structured and progressive 8-week physical activity program involving:
Gentle walking
Portable pedal exerciser
Low-intensity resistance exercises (e.g., resistance bands, seated leg press, hip circles)
Supervised sessions with warm-up and cool-down components
usual careBehavioural
Standard Medical Management: Participants continued with their prescribed medications and routine clinical follow-ups for congestive heart failure as directed by their healthcare providers.
| Study group | Role | What they receive |
|---|---|---|
| Low-Intensity Physical Activity Group | Experimental | Participants in this group underwent an 8-week structured low-intensity physical activity program. The program included gentle walking, use of a portable pedal exerciser, light resistance band exercises, and functional activities like seated leg press and hip circles. Sessions gradually increased in duration and frequency, starting from 2 sessions per week to 3 sessions per week, lasting 20-40 minutes each. The focus was on improving functional capacity, psychological well-being, and quality of life without causing cardiac stress. Receives: Behavioral: Low-Intensity Physical Activity; Behavioral: usual care |
| Usual Care Group | Active comparator | Participants in this group received standard medical care only, with no additional structured physical activity or intervention. They continued their routine treatment and lifestyle without any specific exercise regimen. This group served as the comparison group to evaluate the effects of the physical activity intervention. Receives: Behavioral: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Test (6MWT)
Functional Capacity
Measured: 8 weeks
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Quality of Life
Measured: 8 weeks
Hospital Anxiety and Depression Scale (HADS)
Psychological Well-Being
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 posted14 Jul 2025
- Study start28 Jul 2025 (estimated)
- Primary completion28 Nov 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arjumand Bano, Ms CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062900
- Sponsor's protocol ID
- REC/RCR&AHS/24/0360
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Intensity Physical Activity on Functional Capacity Quality of Life and Psychological Well Being in Congestive Heart Failure Patients Among Different BMI
- ClinicalTrials.gov ID
- NCT07062900
- Acronym / sponsor ID
- REC/RCR&AHS/24/0360
- Conditions
- Heart Failure
- Keywords
- Congestive Heart Failure, low intensity Physical Activity, functional capacity, quality of life, psychological well-being, Body Mass Index.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Jul 2025 (estimated)
- Primary completion
- 28 Nov 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 14 Jul 2025 (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.
This study examined the effects of low-intensity physical activity on functional capacity, quality of life, and psychological well-being in congestive heart failure patients with varying BMI. Forty patients were divided into intervention and control groups. The intervention group followed an 8-week physical activity program, while the control group received usual care. Results showed significant improvement in walk distance, quality of life, and depression scores in the intervention group. The study concludes that low-intensity physical activity effectively improves health outcomes in heart failure patients across different BMI categories.
Detailed description
This randomized controlled trial explored the effects of low-intensity physical activity on functional capacity, quality of life, and psychological well-being in patients with congestive heart failure across different BMI categories. A total of forty patients were selected and randomly assigned to either an intervention group or a control group. The intervention group participated in an eight-week structured low-intensity physical activity program, while the control group continued with usual care without additional physical activity. Various assessment tools were used to evaluate outcomes, including the 6-minute walk test to measure functional capacity, the Kansas City Cardiomyopathy Questionnaire to assess quality of life, and the Hospital Anxiety and Depression Scale to evaluate psychological well-being. The results demonstrated that although both groups showed some improvement, the intervention group experienced significantly greater gains in all measured outcomes. The 6-minute walk distance increased, KCCQ-12 scores improved notably, and depressive symptoms reduced significantly in the intervention group compared to the control. The study concluded that low-intensity physical activity is an effective and feasible intervention to enhance physical and mental health in congestive heart failure patients, irrespective of their BMI category.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Intensity Physical Activity Group | Experimental | Behavioral: Low-Intensity Physical Activity, Behavioral: usual careParticipants in this group underwent an 8-week structured low-intensity physical activity program. The program included gentle walking, use of a portable pedal exerciser, light resistance band exercises, and functional activities like seated leg press and hip circles. Sessions gradually increased in duration and frequency, starting from 2 sessions per week to 3 sessions per week, lasting 20-40 minutes each. The focus was on improving functional capacity, psychological well-being, and quality of life without causing cardiac stress. |
| Usual Care Group | Active comparator | Behavioral: usual careParticipants in this group received standard medical care only, with no additional structured physical activity or intervention. They continued their routine treatment and lifestyle without any specific exercise regimen. This group served as the comparison group to evaluate the effects of the physical activity intervention. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Hospitalized Congestive heart failure patients
- Age 45-70
- Diagnosed with CHF
- BMI all ranges
- Severely underweight: BMI<16 kg/m2
Key exclusion criteria (7 listed)
- Musculoskeletal or neurological disorders
- Severe COPD or other respiratory diseases
- Cognitive impairment
- Cardiac catheter related surgery, valvular surgery within past 6 month
- Recent Lung embolis
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 |
|---|---|---|
| Low-Intensity Physical ActivityThis includes a structured and progressive 8-week physical activity program involving: Gentle walking Portable pedal exerciser Low-intensity resistance exercises (e.g., resistance bands, seated leg press, hip circles) Supervised sessions with warm-up and cool-down components | Behavioural | Low-Intensity Physical Activity Group |
| usual careStandard Medical Management: Participants continued with their prescribed medications and routine clinical follow-ups for congestive heart failure as directed by their healthcare providers. | Behavioural | Low-Intensity Physical Activity Group, Usual Care Group |
Primary outcome
6-Minute Walk Test (6MWT)
Time frame: 8 weeks
Functional Capacity
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time frame: 8 weeks
Quality of Life
Hospital Anxiety and Depression Scale (HADS)
Time frame: 8 weeks
Psychological Well-Being
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- 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.
Arjumand Bano, Ms 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 Low-Intensity Physical Activity in people with 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 10 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: opening soon, as of the sponsor's last update on 14 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact imran amjad, phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Walk Test (6MWT) (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?
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 14 Jul 2025.