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Completed

NCT Number: NCT02966561

Pedometer-based Behavioural Intervention for Individuals With COPD to Stay Active After Rehabilitation

The STAR-study (STay Active after Rehabilitation) investigates in a randomized controlled trial (RCT) the additional effect of a pedometer-based behavior change intervention (BCI) during in-patient pulmonary rehabilitation (PR) on objectively measured physical activity (PA) 6-weeks and 6-months post PR. The BCI uses the behaviour change techniques a) instruction on how, where and when to perform the behavior, b) prompt goal setting for physical activity, c) prompt self-monitoring of behavior and d) feedback on behavior. The primary outcome of PA will be measured using an accelerometer (Actigraph wGT3X) for a time period of seven days, firstly two weeks before rehabilitation begins (T0 = study phase I) as well as six weeks and six months (T3 and T4) after PR. Additionally to predict PA progression after PR, a complex personal diagnostic, including questionnaires as well as functional assessments, is to be carried out at the start (T1 = start of study phase II) and end of PR (T2). This diagnostic is based on the main ideas of the PA-related health competence model (PARC-model) and especially incorporates physical and psychological personal determinants of PA.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics

Bad Reichenhall, Bavaria, 83435, Germany

About this study

A detailed description will be available in the study protocol publication which is generated at the moment (August, 2016).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Main diagnosis for the Pulmonary Rehabilitation is an International Classification of Diseases-Code J44.- (Other chronic obstructive pulmonary disease) at all 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Classifications A-D and stages 1-4.

Exclusion criteria

  • Considerably reduced health status (severe concomitant disease, which will affect the results of the outcome parameters, for example, cancer or severe cardiac, neurological or orthopaedic comorbidities)
  • Considerable reduction of sight and hearing
  • Severe psychiatric condition as secondary diagnosis
  • Lack of ability to speak German

Treatment and study plan

Pedometer-based activity promotion

Behavioral

The central components of the 2 x 45 minutes lasting pedometer-based physical activity behaviour change intervention BCI are the following behaviour change techniques (BCTs):

  • Instruction on how, where and when to perform the behaviour
  • Prompt goal setting for physical activity
  • Prompt self-monitoring of behaviour
  • Feedback on behaviour. Participants receive a pedometer and a booklet with a physical activity diary and associated information on the importance of goal setting and keeping a physical activity diary, exercise recommendations, possibilities to stay active after rehabilitation and appropriate physical activities.

Short patient education and exercise

Behavioral

The central components of the 2 x 45 minutes lasting intervention are revisions of knowledge of the pulmonary rehabilitation (standard care) in combination with related exercises:

  • Revision of knowledge on exercise recommendations
  • Revision of knowledge on possibilities of self-regulation of endurance training exercise intensity with the rate of perceived exertion (BORG-Scale)
  • Revision of self-regulation of endurance exercise intensity
  • Revision of strengthening activities consistent with the exercise recommendations.

Participants receive a booklet with information on the rate of perceived exertion, exercise recommendations, possibilities to stay active after rehabilitation and appropriate physical activities.

Pulmonary rehabilitation (Standard care)

Other

Standard care is an in-patient pulmonary rehabilitation (PR) in a specialized German Rehabilitation Clinic. PR is a comprehensive, multidisciplinary intervention based on a patient assessment followed by a combination of patient-tailored therapies. PR lasts on average 25 days. PR includes the following obligatory main components: Checking and, if required, adjusting the current COPD medication according to current COPD-guidelines; physical training (4-5 units/week endurance training [45 min] and 3 units/week of strength training [45 min] per week, 7 units/week whole body vibration muscle training/week); structured COPD-patient education (6 hours patient education COPD + 1 hour device training); respiratory physiotherapy in groups [2-4 units/week with 45 min]. PR is implemented by an interdisciplinary rehabilitation team.

Primary outcomes

  1. Changes in objectively measured physical activity

    Time frame: 2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4)

    On each measurement occasion physical activity is going to be measured on seven consecutive days with a 3-axis accelerometer (Actigraph wGT3X-BT)

Secondary outcomes

  1. Body-mass index, obstruction, dyspnea, and exercise (BODE index)

    Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)

    Questionnaire: Including body-mass index, airflow obstruction (FEV1), dyspnea (MRC-dyspnea scale) and exercise capacity (6-Min-Walk-Test)

  2. Baseline dyspnea index (BDI) and transitional dyspnea Index (TDI)

    Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4)

    Questionnaire: Baseline and transitional dyspnea

  3. Dyspnea, cough, sputum, pain

    Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4)

    Questionnaire: Numeric Rating Scales (self-developed)

  4. COPD-Anxiety Questionnaire (CAF)

    Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 months after pulmonary rehabilitation (T4)

    Questionnaire: COPD specific anxiety

  5. Patient Health Questionnaire (PHQ-D9)

    Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 months after pulmonary rehabilitation (T4)

    Questionnaire: Depression

  6. St. Georges Respiratory Questionnaire (SGRQ)

    Time frame: 2 weeks before pulmonary rehabilitation (T0); During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 weeks (T3) and 6 months (T4) after pulmonary rehabilitation

    Questionnaire: Health-related quality of life

  7. COPD Assessment Test (CAT)

    Time frame: 2 weeks before pulmonary rehabilitation (T0); During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 weeks (T3) and 6 months (T4) after pulmonary rehabilitation

    Questionnaire: Impact of COPD on health status

  8. Control competence for physical training, physical activity-specific mood regulation and self-control, physical activity-related self efficacy, psychological need satisfaction in exercise

    Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)

    Questionnaire: Facets of physical activity-related health competence (PARC-Model)

  9. Single-target Implicit Association Test (ST-IAT)

    Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)

    Computer-based test: Automatic affect towards physical activity

  10. Stage of change algorithm for physical activity

    Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)

    Questionnaire: Adapted based on the transtheoretical model (TTM)

  11. Sport- and Movement-related Self-Concordance (SSK)

    Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)

    Questionnaire: Self-concordance/ quality of motivation

  12. Affective explicit attitudes towards performing sports activities

    Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)

    Questionnaire: Explicit cognitive and affective attitudes toward sports activities

  13. Breathlessness Catastrophizing

    Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 months after pulmonary rehabilitation (T4)

    Questionnaire: Breathlessness Catastrophizing Scale

  14. Intolerance of Uncertainty Scale (UI-18)

    Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 months after pulmonary rehabilitation (T4)

    Questionnaire: Disposition to react negative on uncertain situations

  15. Life Orientation Test-Revised (LOT-R)

    Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 months after pulmonary rehabilitation (T4)

    Questionnaire: Dispositional optimism

  16. 6 Minute Walking Test

    Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)

    Functional Test

  17. Satisfaction with the pulmonary rehabilitation

    Time frame: During the third and thus last week of pulmonary rehabilitation (T2)

    Questionnaire (self-developed): Satisfaction with interventional components of the pulmonary rehabilitation

  18. Demographic characteristics

    Time frame: During the first week of pulmonary rehabilitation (T1)

    Questionnaire: sex, age, height, marital status, education, weight, self-reported work status

  19. Social medical characteristics

    Time frame: During the first week of pulmonary rehabilitation (T1)

    Initial physical examination including diagnosis, medication, smoking status, lung function

  20. Sick days and use of health care services

    Time frame: 6 weeks after pulmonary rehabilitation (T3); 6 months after pulmonary rehabilitation (T4)

    Questionnaire: Days of incapacity to work, days in hospital, COPD-related emergency treatment

  21. Fear avoidance COPD

    Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 months after pulmonary rehabilitation (T4)

    Questionnaire: COPD disease-related fears

  22. Self-reported physical activity

    Time frame: 2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4)

    Questionnaire: Physical Activity, Exercise, and Sport

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg

Other

Collaborators

  • Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics
  • German Statutory Pension Insurance

Registry information

Official study title

Effects of a Brief Pedometer-based Behavioural Intervention for Individuals With COPD During In-patient Pulmonary Rehabilitation on 6-weeks and 6-months Objectively Measured Physical Activity - A Randomised Controlled Trial

Acronym: STAR

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2016
Registry last updated
Nov 5, 2020

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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