NCT02966600

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

November 7, 2016

Last Update Submit

November 14, 2016

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Static posturography through the centre of pressures measurements (CoP).

    Eight weeks

Secondary Outcomes (4)

  • Gait.

    Eight weeks

  • Freezing of gait.

    Eight weeks

  • The Movement Disorders Society-Unified Parkinson ́s Disease Rating Scale. (MDS-UPDRS).

    Eight weeks

  • The patient- perceived quality of life.

    Eight weeks

Study Arms (2)

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.

Other: Progressive resistance exerciseOther: Physical Activity

Physical Activity

NO INTERVENTION

The control group followed its usual weekly physical activity routine

Interventions

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.

Progressive resistance exercise (PRE)
Physical ActivityOTHER

The control group followed its usual weekly physical activity routine

Progressive resistance exercise (PRE)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • To suffer a neurological disease other than PD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University School of Sports Medicine, University of Oviedo, Spain.

Oviedo, Principality of Asturias, 33005, Spain

Location

Related Publications (2)

  • 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.

    PMID: 38588457DERIVED

  • 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. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PMID: 36602886DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Luis Santos, PhD

    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.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 17, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-11

Locations

ES(1)