- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07430943
Feasibility of Integrating Street Racket Into Ambulatory Pulmonary Rehabilitation (APRacket)
Acceptability, Appropriateness and Feasibility of Integrating Street Racket Into Ambulatory Pulmonary Rehabilitation: A Prospective, Single-Arm Feasibility Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Pulmonary rehabilitation (APR) is an effective and cost-efficient treatment for people with chronic lung diseases, as it can reduce hospital admissions and improve health. Despite this, many patients do not take part or drop out early. Common reasons include low motivation, difficulty attending sessions, or fear that the exercises are too demanding.
Street Racket is a simple, playful, and flexible form of physical activity that may help overcome these barriers. It is easy to adapt, enjoyable in a group setting, and similar in intensity to existing pulmonary rehabilitation exercises. Social and team-based activities like Street Racket may also have positive effects on mental well-being.
The study aims to assess how feasible the activity is, how well it is accepted by participants, and whether it can offer a more engaging and sustainable training option within APR.
Participation in Street Racket sessions is voluntary and possible with or without study participation. For those who take part in the study, the training itself is exactly the same as for non-participants. The only difference is the additional data collection.
Participants are asked to complete a short questionnaire after their first and last Street Racket session about how appropriate and feasible the activity feels. During each session, participants also rate their average and maximum breathlessness. Attendance is recorded, and if someone is absent, the reason is noted when known.
In addition, routinely collected data from pulmonary rehabilitation-such as diagnosis, medication, and standard clinical test results-are analyzed.
Training sessions are adapted to group size and ability level and usually consist of several short playing intervals with breaks and a cool-down. The activity can be modified to match different fitness levels, allowing people with varying physical capacities to participate together.
Study participation ends automatically when the pulmonary rehabilitation program is completed.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mona Lichtblau, PD Dr. med.
- Phone Number: +41 442552220
- Email: mona.lichtblau@usz.ch
Study Contact Backup
- Name: Carmen Wick, Cand. PhD
- Phone Number: +41 43 253 44 05
- Email: carmen.wick@usz.ch
Study Locations
-
-
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Zurich, Switzerland, 8091
- Not yet recruiting
- Consultant Clinic of Pulmonology, University Hospital of Zurich
-
Contact:
- Mona Lichtblau, PD Dr. med.
- Phone Number: +41 442552220
- Email: mona.lichtblau@usz.ch
-
Contact:
- Carmen Wick, Cand. PhD
- Phone Number: +41 43 253 44 05
- Email: carmen.wick@usz.ch
-
Principal Investigator:
- Mona Lichtblau, PD Dr. med.
-
Sub-Investigator:
- Carmen Wick, Cand. PhD
-
Zurich, Switzerland, 8091
- Recruiting
- Consultant Clinic of Pulmonology, University Hospital of Zurich
-
Contact:
- Mona Lichtblau, PD Dr. med.
- Phone Number: +41 442552220
- Email: mona.lichtblau@usz.ch
-
Contact:
- Carmen Wick, Cand. PhD
- Phone Number: +41 43 253 44 05
- Email: carmen.wick@usz.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Any sex or gender
- Age >18 years
- Prescribed APR by a physician and currently participating in APR at the USZ
- Physically and psychologically capable of following instructions and standing/walking for up to one hour (short, seated breaks are allowed if needed)
Exclusion Criteria:
- Require supplemental oxygen therapy that cannot be delivered via a portable backpack system (e.g., large oxygen cylinders on wheels, which pose a fall risk)
- Are unable to follow study procedures due to language barriers, psychological conditions, or orthopaedic limitations that prevent them from standing or walking for up to one hour
- Require walking aids due to impaired balance (e.g., walking sticks, rollator, etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Street Racket Arm
Street Racket is a ball-and-racket game played on the ground without a net.
It resembles table tennis or tennis but is highly flexible, allowing for various playing formats and easy adaptation to individual abilities.
|
Street racket will be offered as an additional, optional training once session for patients once every two weeks within the ambulatory pulmonary rehabilitation program.
The session begins with a 10-minute warm-up led by a physiotherapist, followed by 45 minutes of street racket play.
The content of each session will be adapted based on group size and the playing level of the participants.
A typical session structure consists of four intervals of 8 minutes of play, each separated by 2-minute breaks, and concludes with 5 minutes of cool-down.
Depending on the patients need the training protocol can be adapted, for instance to include more cognitive or balance elements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability, appropriateness and feasibility of Street Racket
Time Frame: Each at the first training and at the end of the pulmonary rehabilitation (after max. 3 months).
|
The primary endpoints acceptability, appropriateness and feasibility will be assessed using patient reported outcomes with the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure (FIM). These instruments have demonstrated strong psychometric properties and will collectively be referred to as the AAF questionnaire. The validated German translation of the AAF, which has also shown reliable and valid psychometric properties will be used in this study. The AAF questionnaire comprises three sections-Acceptability, Appropriateness, and Feasibility-each containing four questions rated on a 5-point Likert scale (1 = Completely disagree, 5 = Completely agree). Scores for each section will be calculated as the mean of the four responses. A mean score above 12 in each section will be considered indicative of a positive result. |
Each at the first training and at the end of the pulmonary rehabilitation (after max. 3 months).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherance rate
Time Frame: After each street racket session, from enrollment until termination of ambulatory pulmonary rehabilitation (max 3 months).
|
Percentage of attended sessions, Documented reasons for non-attendance
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After each street racket session, from enrollment until termination of ambulatory pulmonary rehabilitation (max 3 months).
|
|
Drop-out rate
Time Frame: After each street racket session, from enrollment until termination of ambulatory pulmonary rehabilitation (max 3 months).
|
Drop-out rate in %, categorized reasons for withdrawal (e.g.
medical, motivation, logistics, time)
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After each street racket session, from enrollment until termination of ambulatory pulmonary rehabilitation (max 3 months).
|
|
Qualitative Participant Feedback
Time Frame: After each street racket session, from enrollment until termination of ambulatory pulmonary rehabilitation (max 3 months).
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To gather patient feedback, understand barriers and facilitators as well as improving the Intervention and meet patients' needs, two open-ended questions will be added at the end of the AAF.
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After each street racket session, from enrollment until termination of ambulatory pulmonary rehabilitation (max 3 months).
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Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: After each street racket session, from enrollment until termination of ambulatory pulmonary rehabilitation (max 3 months).
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Number and type of adverse events as defined as (serious) adverse events.
|
After each street racket session, from enrollment until termination of ambulatory pulmonary rehabilitation (max 3 months).
|
|
Perceived dyspnea
Time Frame: After each street racket session, from enrollment until termination of ambulatory pulmonary rehabilitation (max 3 months).
|
After each session the participants will be asked to assess their peak dyspnea level and mean dyspnea level during the session on the modified Borg scale ranging from 0 (no dyspnea) to 10 (maximal dyspnea), which will be recorded on their personal log book.
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After each street racket session, from enrollment until termination of ambulatory pulmonary rehabilitation (max 3 months).
|
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: After each street racket session, from enrollment until termination of ambulatory pulmonary rehabilitation (max 3 months).
|
The Hospital Anxiety and Depression Scale (HADS) has been proven to be reliable and valid in assessing anxiety and depression in healthy as well as clinical populations and older adults from 65 to 80 years although showing ceiling effects. Change in HADS (baseline to post intervention) to explore psychological wellbeing. The HADS is a routinely used questionnaire and is required to be filled out by every patient at the start and end of ambulatory pulmoanry rehabilitation. The HADS consists of two domains, one for anxiety and one for depression. In each domain a sum of the questions is calculated ranging from 0-21 where 0-7 indicates normal, 8-10 mild symptoms and 11-21 moderate to severe symptoms. |
After each street racket session, from enrollment until termination of ambulatory pulmonary rehabilitation (max 3 months).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mona Lichtblau, University of Zurich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Hypertension
- Pathological Conditions, Signs and Symptoms
- Behavior
- Pulmonary Disease, Chronic Obstructive
- Hypertension, Pulmonary
- Motor Activity
Other Study ID Numbers
- APRacket
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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