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The Effect of Resistance Training in Parkinson Disease: A Pilot Study

U

University of Sao Paulo General Hospital

Status

Completed

Conditions

Parkinson Disease

Treatments

Other: Gym Group
Other: Control Group
Other: Free Weights Group

Study type

Interventional

Funder types

Other

Identifiers

NCT02674724
Department of Neurology

Details and patient eligibility

About

To investigate if resistance training exercises performed twice a week with or without gym equipment assistance in a 12-week period could improve balance in patients with Parkinson Disease (PD).

Methods: Sixty three patients with idiopathic PD (Hoehn and Yahr stage II - III) and preserved cognitive function will participate in this study. Patients will be randomized among three intervention groups: resistance training with free weights, resistance training with gym equipment and control group. Investigators will use static platform balance variables to assess the primary end-point outcome measures. For the secondary outcomes measures, most common clinical functional balances tests for PD will be applied: Berg Balance Scale (BBS), Mini-BESTest - Balance Evaluation (Mini-BESTest), Timed Up and Go test (TUG) and variables from dynamic posturography.

Full description

Parkinson's disease is a progressive neurodegenerative disease that affects motor functions and is characterized by bradykinesia, resting tremor, rigidity, and postural instability. Despite of pharmacological treatments, patients remain with deficits in balance, gait, autonomic system functions and cognition which impact on their quality of life.

The effects of resistance training on PD are still controversial when balance and improvement on functional tests are the targets.

Since the results of previous studies about resistance training on balance are still controversial, more interventions are required to address the question if strengthening exercise may improve or not the balance of PD patients. Our exercises will target the trunk, leg and shoulder muscles because of their contribution on patient's posture.

Enrollment

63 estimated patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 50 to 75 years old;
  • Hoehn and Yahr stages II or III;
  • Idiopathic Parkinson disease diagnosed according to the United Kingdom Parkinson's Disease Society Brain Research Centre Criteria, Institute of Neurology, London;
  • Ability to walk independently without walking devices aid;
  • Absence of orthopedic injuries or pain in joints that could interfere on training program;
  • Stable medication regimen for PD treatment at recruitment stage;
  • Mini Mental State Examination Scale (MMSE) ≥ to 27 for literate patients and schooling ≥ of 4 years of formal education;
  • No cardiovascular instability;
  • No pacemaker, decompensated metabolic disease, vestibular dysfunction, and stroke;
  • Availability to come to the clinic twice a week;
  • Not participating in other physical rehabilitation programs during and six months prior to the study.

Exclusion criteria

  • Patients will be excluded if they refuse to participate, do not sign the consent form, have a diagnosis of secondary parkinsonism or present cognitive impairment.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

63 participants in 3 patient groups, including a placebo group

Gym Group
Experimental group
Description:
With gym equipments, twice per week for 12 weeks.
Treatment:
Other: Gym Group
Free Weights Group
Active Comparator group
Description:
With dumbbells, elastics, twice per week for 12 weeks.
Treatment:
Other: Free Weights Group
Control Group
Placebo Comparator group
Description:
The control group will be instructed to perform stretching exercises at home in the same 12-week period, according to an illustrated booklet.
Treatment:
Other: Control Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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