Parkinson DiseaseNCT02966600
Strength Training and Different Subtypes of Parkinson´s Disease
A study testing Progressive resistance exercise and Physical Activity in people with Parkinson Disease, run by University of Oviedo at 1 site in Spain.
Trial summary
The aim of this randomized controlled trial was to assess the impact of progressive resistance exercise (PRE) in PD patients with akinesia and rigidity (AR-subtype). The investigators hypothesized the intervention would have a beneficial effect on the study outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Progressive resistance exercise and Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Apr 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with PD AR-type and Hoehn and Yahr Scale 1-2, (H\&Y)
- Do not express any type of dementia
- Able to stand for two min without assistance;
- Able to walk ten metres without assistance.
Who cannot join
- To suffer a neurological disease other than PD.
- Do not meet some of the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University School of Sports Medicine, University of Oviedo, Spain.
Oviedo, Principality of Asturias, 33005
About this study
Official title: Effects of Progressive Resistance Exercise in Akinetic-rigid Parkinson's Disease Patients
The aim of this randomized controlled trial was to assess the impact of progressive resistance exercise (PRE) in PD patients with akinesia and rigidity (AR-subtype). The investigators hypothesized the intervention would have a beneficial effect on the study outcomes.
Read the detailed description
Twenty-eight patients with PD AR-type of both sexes, were recruited for this trial. Each participant were assigned randomly to either intervention (N=13) or control (N=15) group.
The intervention group participated in sixteen PRE training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one. The control group followed their usual weekly physical activity routine.
All patients underwent antrophometrical and neuromuscular function assessment (CoP measurements -primary outcomes- and the Ten-Meters Walk Test -TMWT- -secondary outcomes-). In addition, they were asked to provide ratings for the Spanish validated versions of the the Freezing of Gait Questionnaire (FOG-Q, 6-item version) -secondary outcomes-, the 39-item Parkinson ́s disease Questionnaire (PDQ39) -secondary outcomes- and the MDS-UPDRS -secondary outcomes-. Additionally, ratings of perceived exertion (RPE) (Borg >6-20 scale) - secondary outcomes-, were recorded at the end of each PRE training session. Tests were carried out at three times: pre-test (before the training program), post-test (eight weeks after pre-tests, at the end of the training period), and four weeks after the post-test (re-test).
- Conditions
- Parkinson Disease
- Being tested
- Progressive resistance exercise, Physical Activity
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance exerciseOther
The intervention group participated in sixteen PRE training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one.
Physical ActivityOther
The control group followed its usual weekly physical activity routine
| Study group | Role | What they receive |
|---|---|---|
| Progressive resistance exercise (PRE) | Experimental | Progressive resistance exercise (PRE) in akinetic-rigid Parkinson's disease patients. Intervention included sixteen PRE training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one. Receives: Other: Progressive resistance exercise; Other: Physical Activity |
| Physical Activity | No intervention | The control group followed its usual weekly physical activity routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static posturography through the centre of pressures measurements (CoP).
Measured: Eight weeks
Secondary outcomes (4)
Gait.
Measured: Eight weeks
Freezing of gait.
Measured: Eight weeks
The Movement Disorders Society-Unified Parkinson ́s Disease Rating Scale. (MDS-UPDRS).
Measured: Eight weeks
The patient- perceived quality of life.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Santos, University of Oviedo
- Investigators
- Luis Santos, PhD, Principal investigator, University School of Sports Medicine, University of Oviedo, Spain. Performance and Health Group, Department of Physical Education and Sport. Faculty of Sports Sciences and Physical Education, University of A Coruna, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966600
- Sponsor's protocol ID
- UOviedo
- Status last verified
- Nov 2016
- First submitted
- 7 Nov 2016
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Resistance Exercise in Akinetic-rigid Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT02966600
- Acronym / sponsor ID
- UOviedo
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 17 Nov 2016 (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 aim of this randomized controlled trial was to assess the impact of progressive resistance exercise (PRE) in PD patients with akinesia and rigidity (AR-subtype). The investigators hypothesized the intervention would have a beneficial effect on the study outcomes.
Detailed description
Twenty-eight patients with PD AR-type of both sexes, were recruited for this trial. Each participant were assigned randomly to either intervention (N=13) or control (N=15) group.
The intervention group participated in sixteen PRE training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one. The control group followed their usual weekly physical activity routine.
All patients underwent antrophometrical and neuromuscular function assessment (CoP measurements -primary outcomes- and the Ten-Meters Walk Test -TMWT- -secondary outcomes-). In addition, they were asked to provide ratings for the Spanish validated versions of the the Freezing of Gait Questionnaire (FOG-Q, 6-item version) -secondary outcomes-, the 39-item Parkinson ́s disease Questionnaire (PDQ39) -secondary outcomes- and the MDS-UPDRS -secondary outcomes-. Additionally, ratings of perceived exertion (RPE) (Borg >6-20 scale) - secondary outcomes-, were recorded at the end of each PRE training session. Tests were carried out at three times: pre-test (before the training program), post-test (eight weeks after pre-tests, at the end of the training period), and four weeks after the post-test (re-test).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive resistance exercise (PRE) | Experimental | Other: Progressive resistance exercise, Other: Physical ActivityProgressive resistance exercise (PRE) in akinetic-rigid Parkinson's disease patients. Intervention included sixteen PRE training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one. |
| Physical Activity | No intervention | –The control group followed its usual weekly physical activity routine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with PD AR-type and Hoehn and Yahr Scale 1-2, (H\&Y)
- Do not express any type of dementia
- Able to stand for two min without assistance;
- Able to walk ten metres without assistance.
Key exclusion criteria (2 listed)
- To suffer a neurological disease other than PD.
- Do not meet some of the inclusion criteria.
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 |
|---|---|---|
| Progressive resistance exerciseThe intervention group participated in sixteen PRE training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one. | Other | Progressive resistance exercise (PRE) |
| Physical ActivityThe control group followed its usual weekly physical activity routine | Other | Progressive resistance exercise (PRE) |
Primary outcome
Static posturography through the centre of pressures measurements (CoP).
Time frame: Eight weeks
4 secondary outcomes
Gait.
Time frame: Eight weeks
Freezing of gait.
Time frame: Eight weeks
The Movement Disorders Society-Unified Parkinson ́s Disease Rating Scale. (MDS-UPDRS).
Time frame: Eight weeks
The patient- perceived quality of life.
Time frame: Eight weeks
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 17 Nov 2016.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- Individual participant dataSharing planned: Undecided
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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.
Luis Santos, PhD principal investigator
University School of Sports Medicine, University of Oviedo, Spain. Performance and Health Group, Department of Physical Education and Sport. Faculty of Sports Sciences and Physical Education, University of A Coruna, Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive resistance exercise and Physical Activity in people with Parkinson Disease, run by University of Oviedo at 1 site in Spain.
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 2 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 17 Nov 2016. 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 Spain. 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?
Static posturography through the centre of pressures measurements (CoP). (time frame: Eight weeks). 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 NCT02966600, 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 17 Nov 2016.