COPDNCT02455206
Counseling During Pulmonary Rehabilitation
A study testing physical activity counseling in people with COPD, run by Zurich University of Applied Sciences at 1 site in Switzerland.
Trial summary
The purpose of this study is to investigate if a physical activity counseling program during pulmonary rehabilitation increases the physical activity level in daily life in patients with Chronic Obstructive Pulmonary Disease. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- COPD
- What is being tested?
- physical activity counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2015to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed COPD (GOLD stages B-D) according to GOLD-guidelines
Who cannot join
- Mental or physical disability (mini-mental score <20) precluding informed consent or compliance with the protocol
- morphine medication
- Primary diagnosis of heart failure
- Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- Severe co-morbidity (acute coronary syndrome, unstable angina terminal renal failure, concomitant pulmonary embolism, very severe pneumonia: CURB65>3)
- Severe untreated arterial hypertension at rest (> 200 mm Hg systolic, > 120 mm Hg diastolic)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Counseling During Pulmonary Rehabilitation on Self-determined Motivation Towards Physical Activity in Patients With Chronic Obstructive Pulmonary Disease
The purpose of this study is to investigate if a physical activity counseling program during pulmonary rehabilitation increases the physical activity level in daily life in patients with Chronic Obstructive Pulmonary Disease.
Read the detailed description
Participants performed a 12 weeks outpatient pulmonary rehab (PR) according to guidelines. Participants allocated to intervention received PR plus physical activity (PA) counselling. PA counselling was performed using "motivational interviewing" techniques and was provided by two experiences physiotherapists independant to the rehab team. After PR and three months follow-up was evaluated if PA counselling during PR increases PA elvel (primary outcome: steps per day) in daily life.
Furthermore, individual, semi-structured interviews were performed in a subgroup of participants in order to gain more detailed information about barriers and enablers of participation in daily-life activities. Participants were invited to two interviews, one right after PR the other after 3 months follow up. A content analysis was performed.
- Conditions
- COPD
- Being tested
- physical activity counseling, Usual care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity counselingBehavioural
5 face-to-face sessions a 30 minutes during 12 weeks pulmonary rehabilitation program.
Usual careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | outpatient pulmonary Rehabilitation program Receives: Behavioral: Usual care |
| Counseling | Experimental | outpatient pulmonary Rehabilitation program plus physical activity counseling Receives: Behavioral: physical activity counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of steps per day
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Winterthur KSW, Schweizer Lungenliga
- Responsible party
- Principal investigator, Anne-Kathrin Rausch, Zurich University of Applied Sciences
- Investigators
- Thomas Hess, Dr med, Principal investigator, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455206
- Sponsor's protocol ID
- KEK-ZH-Nr. 2015-0179
- Status last verified
- Apr 2021
- First submitted
- 21 May 2015
- Last updated
- 15 Apr 2021
- Results posted
- No
Publications
Rausch Osthoff AK, Beyer S, Gisi D, Rezek S, Schwank A, Meichtry A, Sievi NA, Hess T, Wirz M. Effect of counselling during pulmonary rehabilitation on self-determined motivation to be physically active for people with chronic obstructive pulmonary disease: a pragmatic RCT. BMC Pulm Med. 2021 Oct 12;21(1):317. doi: 10.1186/s12890-021-01685-2.
PubMed 34641819Scheermesser M, Reicherzer L, Beyer S, Gisi D, Rezek S, Hess T, Wirz M, Rausch Osthoff AK. The Influence of Pulmonary Rehabilitation and Counselling on Perceptions of Physical Activity in Individuals with COPD - A Qualitative Study. Int J Chron Obstruct Pulmon Dis. 2021 Aug 14;16:2337-2350. doi: 10.2147/COPD.S315130. eCollection 2021.
PubMed 34421298Rausch-Osthoff AK, Greco N, Schwank A, Beyer S, Gisi D, Scheermesser M, Meichtry A, Sievi N, Hess T, Wirz M. Effect of counselling during pulmonary rehabilitation on self-determined motivation towards physical activity in people with chronic obstructive pulmonary disease - protocol of a mixed methods study. BMC Pulm Med. 2017 Aug 17;17(1):115. doi: 10.1186/s12890-017-0457-8.
PubMed 28818057
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Counseling During Pulmonary Rehabilitation on Self-determined Motivation Towards Physical Activity in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02455206
- Acronym / sponsor ID
- KEK-ZH-Nr. 2015-0179
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Collaborators
- Kantonsspital Winterthur KSW, Schweizer Lungenliga
- Study start
- Oct 2015 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate if a physical activity counseling program during pulmonary rehabilitation increases the physical activity level in daily life in patients with Chronic Obstructive Pulmonary Disease.
Detailed description
Participants performed a 12 weeks outpatient pulmonary rehab (PR) according to guidelines. Participants allocated to intervention received PR plus physical activity (PA) counselling. PA counselling was performed using "motivational interviewing" techniques and was provided by two experiences physiotherapists independant to the rehab team. After PR and three months follow-up was evaluated if PA counselling during PR increases PA elvel (primary outcome: steps per day) in daily life.
Furthermore, individual, semi-structured interviews were performed in a subgroup of participants in order to gain more detailed information about barriers and enablers of participation in daily-life activities. Participants were invited to two interviews, one right after PR the other after 3 months follow up. A content analysis was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual careoutpatient pulmonary Rehabilitation program |
| Counseling | Experimental | Behavioral: physical activity counselingoutpatient pulmonary Rehabilitation program plus physical activity counseling |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- confirmed COPD (GOLD stages B-D) according to GOLD-guidelines
Key exclusion criteria (6 listed)
- Mental or physical disability (mini-mental score <20) precluding informed consent or compliance with the protocol
- morphine medication
- Primary diagnosis of heart failure
- Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- Severe co-morbidity (acute coronary syndrome, unstable angina terminal renal failure, concomitant pulmonary embolism, very severe pneumonia: CURB65>3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activity counseling5 face-to-face sessions a 30 minutes during 12 weeks pulmonary rehabilitation program. | Behavioural | Counseling |
| Usual care | Behavioural | Usual Care |
Primary outcome
number of steps per day
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Derived from this study: PubMed 34641819Rausch Osthoff AK, Beyer S, Gisi D, Rezek S, Schwank A, Meichtry A, Sievi NA, Hess T, Wirz M. Effect of counselling during pulmonary rehabilitation on self-determined motivation to be physically active for people with chronic obstructive pulmonary disease: a pragmatic RCT. BMC Pulm Med. 2021 Oct 12;21(1):317. doi: 10.1186/s12890-021-01685-2.
- Derived from this study: PubMed 34421298Scheermesser M, Reicherzer L, Beyer S, Gisi D, Rezek S, Hess T, Wirz M, Rausch Osthoff AK. The Influence of Pulmonary Rehabilitation and Counselling on Perceptions of Physical Activity in Individuals with COPD - A Qualitative Study. Int J Chron Obstruct Pulmon Dis. 2021 Aug 14;16:2337-2350. doi: 10.2147/COPD.S315130. eCollection 2021.
- Derived from this study: PubMed 28818057Rausch-Osthoff AK, Greco N, Schwank A, Beyer S, Gisi D, Scheermesser M, Meichtry A, Sievi N, Hess T, Wirz M. Effect of counselling during pulmonary rehabilitation on self-determined motivation towards physical activity in people with chronic obstructive pulmonary disease - protocol of a mixed methods study. BMC Pulm Med. 2017 Aug 17;17(1):115. doi: 10.1186/s12890-017-0457-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Hess, Dr med principal investigator
Kantonsspital Winterthur KSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity counseling in people with COPD, run by Zurich University of Applied Sciences at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of steps per day (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02455206, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.