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

NCT ID: NCT02966561

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pedometer-based activity promotion

In the context of pulmonary rehabilitation (standard care), the intervention group (IG) additionally receives a pedometer-based physical activity behaviour change intervention (BCI).

Group Type EXPERIMENTAL

Pedometer-based activity promotion

Intervention Type 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.

Pulmonary rehabilitation (Standard care)

Intervention Type 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.

Short patient education and exercise

In the context of pulmonary rehabilitation (standard care), the control group (CG) additionally receives a short patient education in combination with related exercise.

Group Type ACTIVE_COMPARATOR

Short patient education and exercise

Intervention Type 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)

Intervention Type 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.

Interventions

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Pedometer-based activity promotion

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.

Intervention Type BEHAVIORAL

Short patient education and exercise

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.

Intervention Type BEHAVIORAL

Pulmonary rehabilitation (Standard care)

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics

UNKNOWN

Sponsor Role collaborator

German Statutory Pension Insurance

OTHER

Sponsor Role collaborator

University of Erlangen-Nürnberg

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Klaus Pfeifer

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus Pfeifer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Friedrich-Alexander University Erlangen-Nürnberg (FAU), Germany

Wolfgang Geidl, Dr.

Role: PRINCIPAL_INVESTIGATOR

Friedrich-Alexander University Erlangen-Nürnberg (FAU), Germany

Konrad Schultz, Dr.

Role: PRINCIPAL_INVESTIGATOR

Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics, Bad Reichenhall, Germany

Locations

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Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics

Bad Reichenhall, Bavaria, Germany

Site Status

Countries

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Germany

References

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Geidl W, Semrau J, Streber R, Lehbert N, Wingart S, Tallner A, Wittmann M, Wagner R, Schultz K, Pfeifer K. Effects of a brief, pedometer-based behavioral intervention for individuals with COPD during inpatient pulmonary rehabilitation on 6-week and 6-month objectively measured physical activity: study protocol for a randomized controlled trial. Trials. 2017 Aug 29;18(1):396. doi: 10.1186/s13063-017-2124-z.

Reference Type BACKGROUND
PMID: 28851462 (View on PubMed)

Geidl W, Carl J, Cassar S, Lehbert N, Mino E, Wittmann M, Wagner R, Schultz K, Pfeifer K. Physical Activity and Sedentary Behaviour Patterns in 326 Persons with COPD before Starting a Pulmonary Rehabilitation: A Cluster Analysis. J Clin Med. 2019 Aug 29;8(9):1346. doi: 10.3390/jcm8091346.

Reference Type RESULT
PMID: 31470678 (View on PubMed)

Janssens T, Van de Moortel Z, Geidl W, Carl J, Pfeifer K, Lehbert N, Wittmann M, Schultz K, von Leupoldt A. Impact of Disease-Specific Fears on Pulmonary Rehabilitation Trajectories in Patients with COPD. J Clin Med. 2019 Sep 13;8(9):1460. doi: 10.3390/jcm8091460.

Reference Type RESULT
PMID: 31540306 (View on PubMed)

Carl J, Schultz K, Janssens T, von Leupoldt A, Pfeifer K, Geidl W. The "can do, do do" concept in individuals with chronic obstructive pulmonary disease: an exploration of psychological mechanisms. Respir Res. 2021 Oct 6;22(1):260. doi: 10.1186/s12931-021-01854-1.

Reference Type DERIVED
PMID: 34615520 (View on PubMed)

Other Identifiers

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5.011-6.031.115

Identifier Type: -

Identifier Source: org_study_id