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

Summary

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

BEHAVIORAL

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.

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.

OTHER

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.

Sponsors & Collaborators

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

  collaborator UNKNOWN

• German Statutory Pension Insurance

  collaborator OTHER

• University of Erlangen-Nürnberg

  lead OTHER

Principal Investigators

• Klaus Pfeifer, Prof. Dr. · Friedrich-Alexander University Erlangen-Nürnberg (FAU), Germany

• Wolfgang Geidl, Dr. · Friedrich-Alexander University Erlangen-Nürnberg (FAU), Germany

• Konrad Schultz, Dr. · Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics, Bad Reichenhall, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• Germany

Study Locations