Enhancement of Physical Activity in Elderly Patients With Diastolic Heart Failure by a Motivational Intervention

NCT03402490 | Completed

• 1 other identifier: 12345 add-on
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of our pilot study is to evaluate the feasibility, acceptance and efficacy of motivational interviewing (MI) to support elderly patients with heart failure with preserved ejection fraction (HFpEF) in maintaining or starting physical activity (PA).

Conditions

Diastolic Heart Failure

Keywords

Motivational interviewing; physical activity; feasibility; HFpEF

Outcome Measures

Primary Outcomes (4)

• Adherence to intervention

  To evaluate the feasibility of motivational counseling to enhance physical activity patients´ adherence to appointments is assessed as number / percentage of sessions attended

  Over 6 month intervention period

• Patient acceptance of intervention

  To assess how patients evaluate the Intervention, i.e. receiving motivational counseling, they were asked to fill in evaluation sheets

  At 6-month assessment

• Effectiveness (peak VO2)

  Changes in the maximal exercise capacity (peak VO2) during a symptom-limited cardiopulmonary exercise test on a bicycle ergometer.

  Change from baseline to 6-month assessment

• Effectiveness (6-minute walk distance)

  Six-minutes walking distance

  Change from baseline to 6-month assessment

Other Outcomes (2)

• Motivation

  Change from baseline to 6-month assessment.

• Physical activity

  Change from baseline to 6-month assessment.

Study Arms (2)

Motivational interviewing

EXPERIMENTAL

Over a time span of 6 months, participants in the intervention group received up to 7 sessions of motivational counseling, lasting 15-30 minutes each, to enhance physical activity.

Behavioral: Motivational interviewing

Usual care

NO INTERVENTION

Participants who served as controls received usual care.

Interventions

Motivational interviewing BEHAVIORAL

Motivational interviewing

Eligibility Criteria

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

You may qualify if:

• preserved left ventricular systolic function (left ventricular ejection fraction \>= 50%),
• echocardiographically determined diastolic dysfunction (grade ≥ 1),
• New York Heart association functional classes I, II or III,
• at least one cardiovascular risk-factor (overweight, diabetes, hypertension, smoking or hyperlipidemia)
• participation in Ex-DHF main study
• written informed consent

You may not qualify if:

• Non-cardiac causes for heart failure-like symptoms
• Chronic obstructive pulmonary disease GOLD stages ≥II
• Anaemia (haemoglobin \<11 mg/dL)
• Significant renal dysfunction (eGFR \<30 mL/min/1.73 m\*\*2 indexed to BSA)
• Significant peripheral artery disease (Fontaine ≥IIb)
• Musculoskeletal disease that contributes to reduced exercise performance
• Specific cardiomyopathy (e.g. amyloidosis)
• Haemodynamically significant valvular disorders
• Significant coronary artery disease (current angina pectoris Canadian Cardiovascular Society Class ≥II or positive stress test, myocardial infarction or coronary artery bypass graft within the last 3 months)
• Any inability or contraindication to participate in cardiopulmonary exercise testing or in an exercise programme (e.g. physiological, mental) or to supply essential information (e.g. questionnaire, diary)
• Ineffective control of resting blood pressure (≥140/90 mmHg or ≥160/100 mmHg with ≥3 antihypertensive drugs) or of resting heart rate (≥100 b.p.m.)
• Expected low adherence (e.g. by travel distance to trial site; planned absences longer than 4 weeks during follow-up) or ongoing drug abuse
• Pregnant or nursing women
• Concomitant participation in other interventional clinical trials

Sponsors & Collaborators

• University of Göttingen: lead
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator

MeSH Terms

Conditions

Heart Failure, Diastolic; Motor Activity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: One group of participants received motivational counseling to enhance physical activity; the other group received usual care

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 18, 2018
• Study Start: June 18, 2013
• Primary Completion: December 8, 2015
• Study Completion: December 8, 2015
• Last Updated: January 18, 2018

Record last verified: 2018-01