AzTrials
AzTrials

Parkinson's DiseasePhase 3ParkFitNCT00748488

Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease

A Phase 3 study testing Physical therapy aimed to move safely and Physical Therapy aimed to improve Physical Activity in people with Parkinson's Disease, run by Radboud University Medical Center at 32 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with Parkinson's disease (PD) are heavily inclined towards a sedentary lifestyle. This is caused by a combination of physical impairments and cognitive dysfunction. However, regular physical activity in PD is highly desirable, for two reasons. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Physical therapy aimed to move safely and Physical Therapy aimed to improve Physical Activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
32 sitesNetherlands
Study dates
Sep 2008to Dec 2011
Phase
Phase 3
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Idiopathic PD
  • Hoehn and Yahr stage I-III
  • Between 40 and 75 years old
  • Not meeting the norm for healthy physical activity: the latter being defined according to international standards as either five days a week 30 minutes of moderate-intensity physical activity, or 3 days a week 20 minutes of vigorous-intensity physical activity

Who cannot join

  • Wheel chair bounded
  • Severe co-morbidity (e.g. orthopaedic disorders or chronic hart failure)
  • Severe cognitive decline, defined as Mini Mental State Examination < 24

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Netherlands32 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, Postbus 1101, 5200 BD

  • Medisch Centrum alkmaar

    Alkmaar, Postbus 50, 1800 AM

  • Gelreziekenhuizen

    Apeldoorn, Postbus 9014, 7300 DS

  • Tergooiziekenhuizen

    Blaricum, Postbus 900, 1250 CA

  • Amphia Ziekenhuis

    Breda, Postbus 90157, 4800 RL

  • Reinier de Graaf Groep

    Delft

  • Deventer Ziekenhuis

    Deventer

  • Slingeland Ziekenhuis

    Doetinchem

  • Ziekenhuis Gelderse Vallei

    Ede, Postbus 9025, 6710 HN

  • Catharina ziekenhuis

    Eindhoven, Postbus 1350, 5602 ZA

  • St. Anna Ziekenhuis

    Geldrop

  • Groene Hart Ziekenhuis

    Gouda

  • Kennemer Gasthuis

    Haarlem

  • Atrium Medisch Centrum

    Heerlen

  • Elkerliek ziekenhuis

    Helmond, Postbus 98, 5700 AB

  • Tergooiziekenhuizen

    Hilversum, Postbus 10016, 1201 DA

  • Westfriesgasthuis

    Hoorn

  • Academisch Ziekenhuis Maastricht

    Maastricht

  • Ziekenhuis Bernhoven

    Oss

  • Laurentius Ziekenhuis

    Roermond

  • Franciscus Ziekenhuis

    Roosendaal

  • Erasmus Medisch Centrum

    Rotterdam

  • Maasstad Ziekenhuis

    Rotterdam

  • Sint Franciscus Gasthuis

    Rotterdam

  • Vlietland Ziekenhuis

    Schiedam

  • Maaslandziekenhuis

    Sittard, Postbus 5500, 6130 MB

  • Orbis Medisch Centrum

    Sittard

  • Hagaziekhuis

    The Hague, Postbus 40551, 2504 LN

  • Medisch Centrum Haaglanden

    The Hague, Postbus 432, 2501 CK

  • Vie Curie Medisch Centrum

    Venlo, Postbus 1926, 5900 BX

  • 't Lange Land Ziekenhuis

    Zoetermeer

  • De Gelreziekenhuizen

    Zutphen, Postbus 9020, 7200 GZ

Other trials in Netherlands

About this study

Official title: The ParkFit Study; Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease

Patients with Parkinson's disease (PD) are heavily inclined towards a sedentary lifestyle. This is caused by a combination of physical impairments and cognitive dysfunction. However, regular physical activity in PD is highly desirable, for two reasons. First, physical activity has positive generic effects in preventing complications such as cardiovascular diseases, type II diabetes mellitus, osteoporosis and certain cases of cancer. Secondly, physical activity has additional disease-specific merits in PD such as depression, sleep disturbances and constipation. These effects lead to raised quality of life. Furthermore, animal studies suggest that physical activity could slow down disease progression.

Simply informing patients about the importance of physical activity is not enough to initiate and maintain an adequate level of physical activity. We propose to develop a physical activity promoting program for sedentary patients with PD in order to raise their level of daily physical activity.

Read more

Objective: The first aim of the study is to investigate whether a physical activity promotion program will result in an increase in physical activity in sedentary patients with PD.

The second aim is to demonstrate an increase in physical fitness and quality of life.

Read the detailed description

no extensive description

Being tested
Physical therapy aimed to move safely, Physical Therapy aimed to improve Physical Activity
Keywords
Parkinson, Physical Therapy, Physical Activity
Medical subject headings
Parkinson Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical therapy aimed to move safelyOther

    Physical Therapy according to the Dutch guidelines for Physical Therapy in Parkinson's Disease solely focused on safety of movement.

    Duration program: 2 years Maximum number of sessions: 35 per year Duration sessions: 30 minutes

  • Physical Therapy aimed to improve Physical ActivityOther

    Physical Therapy according to the Dutch guidelines for Physical Therapy in Parkinson's Disease combined with a coaching program aimed to promote the level of physical activity Duration program: 2 years Maximum number of sessions: 35 per year Duration of sessions: 30 minutes

Study groups in NCT00748488
Study groupRoleWhat they receive
AExperimentalPhysical Therapy aimed to promote the level of physical activity
Receives: Other: Physical Therapy aimed to improve Physical Activity
BActive comparatorPhysical Therapy aimed to move safely
Receives: Other: Physical therapy aimed to move safely

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of Physical Activity based on the LAPAQ questionnaire

    Measured: Average of 6, 12, 18 and 24 months

Secondary outcomes (13)

  1. One week diary of physical activity

    Measured: Average of 6, 12, 18 and 24 months

  2. Level of Physical Activity based on an activity monitor

    Measured: continuous during 24 months

  3. Physical Fitness (Six Minute Walk Test & Astrand bicycle test)

    Measured: 12 and 24 months

  4. Quality of Life (PDQ-39)

    Measured: 6, 12, 18 and 24 months

  5. Mood and Depression (HADS)

    Measured: 6, 12, 18 and 24 months

  6. Cognition (CANTAB)

    Measured: 12 and 24 months

  7. disease severity ( Nine Hole Peg test, UPDRS)

    Measured: 12 and 24 months

  8. Safety(Falls)

    Measured: monthly

  9. Mobility (Timed up and go test)

    Measured: 12 and 24 months

  10. Fatigue (FSS)

    Measured: 6, 12, 18 and 24 months

  11. Medication (questionnaire)

    Measured: 6, 12, 18 and 24 months

  12. Medical Costs (questionnaire)

    Measured: 6, 12, 18 and 24 months

  13. Quality of Sleep (SCOPA-sleep)

    Measured: 6, 12, 18 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00748488
Sponsor's protocol ID
50-50310-98-034
Acronym
ParkFit
Status last verified
Jan 2012
First submitted
5 Sep 2008
Last updated
31 Jan 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • van Nimwegen M, Speelman AD, Overeem S, van de Warrenburg BP, Smulders K, Dontje ML, Borm GF, Backx FJ, Bloem BR, Munneke M; ParkFit Study Group. Promotion of physical activity and fitness in sedentary patients with Parkinson's disease: randomised controlled trial. BMJ. 2013 Mar 1;346:f576. doi: 10.1136/bmj.f576.

    PubMed 23457213

  • van Nimwegen M, Speelman AD, Smulders K, Overeem S, Borm GF, Backx FJ, Bloem BR, Munneke M; ParkFit Study Group. Design and baseline characteristics of the ParkFit study, a randomized controlled trial evaluating the effectiveness of a multifaceted behavioral program to increase physical activity in Parkinson patients. BMC Neurol. 2010 Aug 19;10:70. doi: 10.1186/1471-2377-10-70.

    PubMed 20723221

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Physical therapy aimed to move safely and Physical Therapy aimed to improve Physical Activity in people with Parkinson's Disease, run by Radboud University Medical Center at 32 sites in Netherlands.

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 4 inclusion and 3 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 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Netherlands. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Level of Physical Activity based on the LAPAQ questionnaire (time frame: Average of 6, 12, 18 and 24 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 NCT00748488, which also lists 2 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 31 Jan 2012.

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