Clinical trial NCT03402490: Enhancement of Physical Activity in Elderly Patients With Diastolic Heart Failure by a Motivational Intervention
Official title: Enhancement of Physical Activity in Elderly Patients With Diastolic Heart Failure by a Motivational Intervention - Pilot Data From an add-on Following the Ex-DHF Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diastolic Heart Failure
Keywords: Motivational interviewing
physical activity
feasibility
HFpEF
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2018-01-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group of participants received motivational counseling to enhance physical activity; the other group received usual care
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: Patients discharged from the Ex-DHF trial were recruited from June 2013 to December 2015 and offered participation in a controlled add-on pilot study. The treatment group (n=19) received 5 sessions of MI, each lasting 15-30 min over 6 months to enhance physical activity.

For the first two and the last sessions participants met with the psychologist-counsellor face-to-face for about 45 minutes. The remaining three sessions could be conducted via telephone or face-to-face, depending on participants' preferences, and typically lasted 15-30 minutes. Per study protocol, counsellors (physicians and psychologists trained in motivational interviewing) assisted the participants in: (1) Setting goals for their physical activity; (2) developing a plan to increase physical activities; (3) setting specific plans for the implementation of the plan; and (4) overcoming possible barriers. Participants were also asked to keep track of their daily physical activity in a diary, which counsellors then discussed with them during the sessions.

After patients had given their written informed consent, counsellors assessed all participants via structured interview and self-rating scales. At baseline only, sociodemographic information was recorded.

At baseline and at the final 6-month visit participants' motivation to be physically active in the upcoming weeks was assessed using the SSK-scale ("Sportbezogene Selbstkonkord" = sports-related self-concordance, Seelig and Fuchs 2006) to assess the self concordance of sport- and exercise-related goals.

The kind and extent of patients' daily physical activity was recorded using patient diaries. At baseline and 6 months we also conducted a symptom-limited cardiopulmonary exercise test on a bicycle ergometer, in order to assess changes in maximum rate of oxygen consumption during the last 30 seconds before the termination of the exercise (peak oxygen consumption (VO2 \[ml/min/kg\])) as measure of maximal exercise capacity. Participants also completed the 6-minute walk test on flat surface (6-MWT) as an additional parameter to assess submaximal exercise capacity.

Additionally, at the 6-month assessment, intervention participants filled out a questionnaire about their subjective evaluation of the counseling program.

The control group (n=20) received usual care.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Adherence to intervention
timeFrame: Over 6 month intervention period
measure: Patient acceptance of intervention
timeFrame: At 6-month assessment
measure: Effectiveness (peak VO2)
timeFrame: Change from baseline to 6-month assessment
measure: Effectiveness (6-minute walk distance)
timeFrame: Change from baseline to 6-month assessment
Secondary outcomes:
Other outcomes:
measure: Motivation
timeFrame: Change from baseline to 6-month assessment.
measure: Physical activity
timeFrame: Change from baseline to 6-month assessment.
Locations:
Study officials:
References: