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A 3-month Multicenter randomized trial to evaluate the efficacy of a Physical Activity Promotion Program on the experience of physical activity in patients with COPD (Mr PAPP)

A 3-month Multicenter randomized trial to evaluate the efficacy of a Physical Activity Promotion Program on the experience of physical activity in patients with COPD (Mr PAPP) - Impact of *telecoaching program* on physical activity in patients with COPD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40168
Enrollment
80
Registered
2014-05-06
Start date
2014-07-08
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease COPD

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: •Written informed consent must be obtained before any assessment is performed. •Male and female patients >= 40 years of age •Diagnosis of COPD (GOLD criteria: post bronchodilator FEV1/FVC

Exclusion criteria

Exclusion criteria: •Orthopedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator. Specifically if the patients* condition/ co-morbidities are such that physical activity cannot be increased. •Respiratory diseases other than COPD (e.g. asthma) •Cognitive reading impairment and/or difficulties to manage electronic devices precluding interaction with the healthbase and PDA, as judged by the investigator •Participating in or scheduled to start a rehabilitation program during the study. If the patient wishes to participate in pulmonary rehabilitation for any reason the patient can be enrolled in the study only at the end of rehabilitation.

Design outcomes

Primary

MeasureTime frame
The primary objectives are: • To assess the impact of a physical activity promotion program on physical activity in patients with COPD in addition to usual care. This will be measured by the PROactive monitors (ActiGraph® and DynaPort®), as the change in average daily number of steps at baseline (during the week prior to visit 101) and at the end of the 3-month epoch (during the week prior to Visit 102). • To assess construct validity of the daily version of PROactive instrument and its responsiveness to a telecoaching program in addition to usual care in COPD patients.

Secondary

MeasureTime frame
The secondary objectives are to assess change from baseline to 3 months between the intervention group and the control group in: 1-Time spent in at least moderate physical activity 2- Proportion of patients showing an increase of physical activity by >20% 3- Exercise capacity (6-minute walking test (6MWT); Incremental shuttle walk test (ISWT) in a subset of mild patients) 4- Muscle strength (as measured by quadriceps maximal volitional contraction) 5- COPD symptoms and health-related quality of life (as measured by the CAT, CCQ, HADS, mMRC and SGRQ-C) 6- Change from baseline to 3 months between the intervention group and the control group in average daily number of steps 7- Satisfaction with the coaching system

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)