Self-care in Older Frail Persons With Heart Failure Intervention

NCT05009706 | Unknown

• 1 other identifier: Dnr 2020-00295
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of the randomized controlled study is to evaluate the effects of physical exercise, nutrition and symptom management on physical capacity in older, frail persons with heart failure.

Conditions

Self Care; Heart Failure; Frailty

Keywords

self care; heart failure; symptom management; exercise; nutrition

Outcome Measures

Primary Outcomes (1)

• Change in physical performance

  The "Short Physical Performance Battery" is composed of "standing balance", "gait speed", and "timed repeated chair rise". The total score range from minimum 0 to maximum 12, with higher scores indicating better physical performance.

  3 months

Secondary Outcomes (11)

• Symptom burden

  Baseline, 3 and 6 months

• Health related quality of life

  Baseline, 3 and 6 months

• Aerobic capacity/endurance

  Baseline, 3 and 6 months

• Frailty

  Baseline, 3 and 6 months

• Perceived physical effort

  Baseline, 3 and 6 months

Other Outcomes (6)

• Objective physical activity

  Baseline, 3 and 6 months

• Subjective physical activity

  Baseline, 3 and 6 months

• Experiences of patients

  3 months

Study Arms (2)

Self Care group

EXPERIMENTAL

Patients who are randomized to the intervention Self Care group will get advice and support on physical excercise, nutrition and symptom management to perform at home for 12 weeks. Once a week, patients will come to the hospital for follow-up and to exercise with a physiotherapist.

Other: Self-care in Older frail Persons with Heart failure Intervention (SOPHI)

Control group

NO INTERVENTION

Patients who are randomized to the Control group will receive ordinary health care (from an outpatient clinic), but will also be encouraged to follow recommendation of 150 minutes/week of moderate physical activity (12 weeks). To compensate for the extra attention received by the intervention group by the advice/support, the patients in the control group will be dialed with a nurse at 3, 6 and 9 weeks to discuss their current activity.

Interventions

Self-care in Older frail Persons with Heart failure Intervention (SOPHI) OTHER

Patients who are randomized to the Self Care group will receive oral and written information, advice and support on following activities: excercise (from physiotherapist), nutrition (dietician) and symptom management (nurse), based on patient´s individual needs and abilities. The Self Care group will perform the activities daily at home. Once a week, patients come to the hospital to exercise with the support of a physiotherapist. Once a week or every other week patients will meet (at hospital or by phone) the dietician and nurse to solve possible problems and to follow-up food/nutrition intake and symptoms/symptom management.

Self Care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at geriatric clinic
• Diagnosed with heart failure (independent of Ejection Fraction (EF): both patients with preserved EF or reduced EF can be included
• New York Heart Association functional class II - III
• Clinical frailty level 4-6 (moderate frailty)
• Discharge from hospital to home

You may not qualify if:

• New York Heart Associacion functional class I or IV
• Clinical frailty level 1-3 (no/mild frailty) and 7-9 (severe frailty)
• The patient is unable to perform gait tests due to visual (see a TV screen at a 3 meter distance), cognitive (assessed by nurse or doctor) or motor impairment (the patient should be able to stand up from sitting and have the ability to walk with or without a walker or other walking aid).
• The patient is unable to follow instructions (assessed by nurse or doctor)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska Universitetssjukhuset, Tema Inflammation och Åldrande

Huddinge, 14186, Sweden

Location

MeSH Terms

Conditions

Heart Failure; Frailty; Motor Activity

Interventions

Self Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nana Waldréus, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 17, 2021
• Study Start: September 6, 2021
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: April 7, 2022

Record last verified: 2022-03

Locations

SE (1)