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Completed

NCT Number: NCT03402490

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

Behavioral

Primary outcomes

  1. Adherence to intervention

    Time frame: Over 6 month intervention period

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

  2. Patient acceptance of intervention

    Time frame: At 6-month assessment

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

  3. Effectiveness (peak VO2)

    Time frame: Change from baseline to 6-month assessment

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

  4. Effectiveness (6-minute walk distance)

    Time frame: Change from baseline to 6-month assessment

    Six-minutes walking distance

Other outcomes

  1. Motivation

    Time frame: Change from baseline to 6-month assessment.

    Participants' motivation to be physically active was registered using the SSK (Sports-related self-concordance) scale. The self-concordance score is computed by subtracting the sum of the introjected and extrinsic motivation from the sum of the intrinsic and identified motivation subscales, with resulting scores ranging from -10 to +10 (higher value = higher self-concordance)

  2. Physical activity

    Time frame: Change from baseline to 6-month assessment.

    The kind and extent of patients' daily physical activity was recorded using patient diaries

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Registry information

Official study 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

Acronym: Ex-DHFadd-on

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 18, 2018
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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