NCT07062900

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

July 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

July 28, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 3, 2025

Last Update Submit

July 3, 2025

Conditions

Keywords

Congestive Heart Failure, low intensity Physical Activity, functional capacity, quality of life, psychological well-being, Body Mass Index.

Outcome Measures

Primary Outcomes (3)

  • 6-Minute Walk Test (6MWT)

    Functional Capacity

    8 weeks

  • Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    Quality of Life

    8 weeks

  • Hospital Anxiety and Depression Scale (HADS)

    Psychological Well-Being

    8 weeks

Study Arms (2)

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.

Behavioral: Low-Intensity Physical ActivityBehavioral: 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.

Behavioral: usual care

Interventions

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

Low-Intensity Physical Activity Group
usual careBEHAVIORAL

Standard Medical Management: Participants continued with their prescribed medications and routine clinical follow-ups for congestive heart failure as directed by their healthcare providers.

Low-Intensity Physical Activity GroupUsual Care Group

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arjumand

Lahore, Punjab Province, 40100, Pakistan

Location

MeSH Terms

Conditions

Heart FailurePsychological Well-Being

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPersonal SatisfactionBehavior

Study Officials

  • Arjumand Bano, Ms CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arjumand Bano, Ms CPPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 14, 2025

Study Start

July 28, 2025

Primary Completion

November 28, 2025

Study Completion

December 10, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations