NCT03743012

Brief Summary

This is a randomized controlled trial of participants with heart failure randomized into usual care plus integrated cardiac rehabilitation or usual care only. The rehabilitation protocol will comprise one month of thrice weekly sessions including supervised aerobic exercises and counseling, followed by two months of monitored home based exercises prescribed weekly. Cardiopulmonary performance status, depression and quality of life will be assessed at enrollment and upon completion of the protocol using the 6-minute walk time distance test. Plasma samples will be collected and bio-banked for metabolomic profiling and comparative outcome analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable heart-failure

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

November 1, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

12 months

First QC Date

November 14, 2018

Last Update Submit

November 25, 2019

Conditions

Heart Failure

Keywords

rehabilitationmetabolomics

Outcome Measures

Primary Outcomes (1)

  • 6 minute walk time distance

    This study seeks to find out whether 6 minute walk time distance among patients undergoing integrated cardiac rehabilitation is different when compared to usual care study participants.

    3 months

Secondary Outcomes (2)

  • Depression severity

    3 months

  • Quality of living

    3 months

Other Outcomes (2)

  • Metabolomic Profile

    3 months

  • Inflammatory Profile

    3 months

Study Arms (2)

Integrated cardiac rehabilitation

EXPERIMENTAL

Participants enrolled in integrated cardiac rehabilitation plus usual care

Other: Integrated cardiac rehabilitation

Usual Care

ACTIVE COMPARATOR

Participants receiving usual care only

Other: Usual Care

Interventions

Integrated cardiac rehabilitationOTHER

Participants enrolled to the integrated cardiac rehabilitation arm will participate in individually tailored rehabilitation sessions that will involve aerobic activity focused on exertion at the participant's aerobic threshold (AT) over a duration of three months.

Integrated cardiac rehabilitation
Usual CareOTHER

Participants randomized to the usual care arm will be instructed on the benefits of exercise and continue with usual care. Participant activity will be tracked monthly using pedometers for three months of follow up.

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NYHA Class II or III heart failure
  • Owns a mobile telephone
  • Can participate in supervised exercise three times a week
  • Can read/ primary care giver can read in English or Kiswahili

You may not qualify if:

  • Recent acute illness requiring hospitalization in the preceding 4 weeks.
  • Limitation of activity because of factors other than fatigue or exertional dyspnea, such as arthritis, claudication in the legs, angina, advanced co morbidities.
  • Known uncontrolled arrhythmia.
  • Heart failure due to congenital heart disease.
  • Pregnant patients as may be confirmed by patient report or urine pregnancy tests
  • Heart failure due to obstructive cardiomyopathy including mitral stenosis and aortic stenosis.
  • Use of pacemakers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moi teaching and Referral Hospital

Eldoret, Uasin Gishu County, 30100, Kenya

Location

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Gerald Bloomfield, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Felix Barasa

    Moi Teaching and Referral Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 15, 2018

Study Start

November 1, 2018

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

November 27, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)