Long-term Effects of a 3-month Pedometer-based Program to Enhance Physical Activity in Patients With Severe COPD

NCT03114241 | Completed

• 1 other identifier: Basec-Nr. 2016-00151
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Long-term evaluation of a coaching program which helps patients with severe COPD to increase their daily step count, in addition to usual care.

Conditions

COPD

Keywords

COPD; Physical activity; Endothelial function

Outcome Measures

Primary Outcomes (1)

• Difference between the changes in number of steps per day (assessed over one week) from baseline to 12 months in the intervention group compared to controls.

  At visits, the number of steps per day will be assessed by a multisensory band (SenseWear Pro™; Bodymedia Inc., Pittsburgh, PA, USA) which will be worn on the upper left arm for 7 consecutive days.

  12 months

Secondary Outcomes (1)

• Assessment of endothelial function by flow-mediated dilatation

  12 months

Other Outcomes (11)

• Number of COPD exacerbations

  12 months

• Height

  12 months

• Weight

  months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

An increase in step count of 15% compared to baseline will be set as the minimal goal for each patient during 3 months.

Behavioral: Intervention

Control

NO INTERVENTION

Usual care.

Interventions

Intervention BEHAVIORAL

Patients allocated to the intervention group receive a pedometer. They are encouraged to be more active by using the pedometer to measure the number of steps walked daily. An increase in step count of 15% compared to baseline will be set as the minimal goal for each patient. Monthly telephone calls are indicated to encourage compliance with the protocol and motivate patients to enhance their level of activity. The coached program ends after three months but patients keep their pedometer and are encouraged to sustain an increased level of daily physical activity for additional 9 months (end of study).

Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Age ≥ 40 years
• Severe COPD (FEV1\<50%) diagnosed according to GOLD-guidelines (www.goldcopd.org)

You may not qualify if:

• Physical or intellectual impairment precluding informed consent or protocol adherence
• Acute or recent (within the last 6 weeks) exacerbation of COPD
• Attending a pulmonary rehabilitation program within the last 6 months
• Pregnant patients

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

• Kohlbrenner D, Sievi NA, Senn O, Kohler M, Clarenbach CF. Long-Term Effects of Pedometer-Based Physical Activity Coaching in Severe COPD: A Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Nov 6;15:2837-2846. doi: 10.2147/COPD.S279293. eCollection 2020.

  PMID: 33192057 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Methods

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)

Investigative Techniques

Study Officials

• Christian F Clarenbach, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients will be randomized 1:1 to one of the two groups: conventional care group or intervention group. No minimization procedures are used.

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 14, 2017
• Study Start: May 2, 2017
• Primary Completion: May 20, 2020
• Study Completion: May 20, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)