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

NCT02966561 | Completed

• 1 other identifier: 5.011-6.031.115
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Pulmonary Rehabilitation; Physical Activity; Behaviour Change; Pedometer

Outcome Measures

Primary Outcomes (1)

• Changes in objectively measured physical activity

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

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

Secondary Outcomes (22)

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

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

• Baseline dyspnea index (BDI) and transitional dyspnea Index (TDI)

  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)

• Dyspnea, cough, sputum, pain

  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)

• COPD-Anxiety Questionnaire (CAF)

  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)

• Patient Health Questionnaire (PHQ-D9)

  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)

Study Arms (2)

Pedometer-based activity promotion

EXPERIMENTAL

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

Behavioral: Pedometer-based activity promotion; Other: Pulmonary rehabilitation (Standard care)

Short patient education and exercise

ACTIVE COMPARATOR

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

Behavioral: Short patient education and exercise; Other: Pulmonary rehabilitation (Standard care)

Interventions

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.

Pedometer-based activity promotion

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.

Short patient education and exercise

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.

Pedometer-based activity promotion; Short patient education and exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg: lead
• Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics: collaborator
• German Statutory Pension Insurance: collaborator

Study Sites (1)

Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics

Bad Reichenhall, Bavaria, 83435, Germany

Location

Related Publications (4)

• 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.

  PMID: 28851462 BACKGROUND

• 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.

  PMID: 31470678 RESULT

• 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.

  PMID: 31540306 RESULT

• 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.

  PMID: 34615520 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Exercise; Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Klaus Pfeifer, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

• Wolfgang Geidl, Dr.

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

  PRINCIPAL INVESTIGATOR

• Konrad Schultz, Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: November 17, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)