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

University of Erlangen-Nürnberg

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Behavioral: Short patient education and exercise; Behavioral: Pedometer-based activity promotion; Other: Pulmonary rehabilitation (Standard care)

Study type: Interventional

Funder types: Other

Identifiers

NCT02966561

5.011-6.031.115

Details and patient eligibility

About

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.

Full description

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

Enrollment: 418 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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418 participants in 2 patient groups

Pedometer-based activity promotion

Experimental group

Description:

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

Treatment:

Other: Pulmonary rehabilitation (Standard care)

Behavioral: Pedometer-based activity promotion

Short patient education and exercise

Active Comparator group

Description:

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

Treatment:

Other: Pulmonary rehabilitation (Standard care)

Behavioral: Short patient education and exercise