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

NCT02674724 | Completed DMC

• 1 other identifier: Department of Neurology
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Resistance Training; Postural Balance; Exercise

Outcome Measures

Primary Outcomes (1)

• Postural sway on Static Posturography

  Static Posturography is a technique used to objectively assess postural sway with patients standing still on a fixed platform that measures center of pressure displacement. Tests were standardized such as the feet position, the eye gaze and environment light, with three trials of 60-second test in eyes - open, eyes closed and eyes open in dual task condition. Investigators will analyze the anteroposterior displacement, medial-lateral displacement, area, velocity and path length.

  12 weeks

Secondary Outcomes (5)

• Balance on Berg Balance Scale

  12 weeks

• Balance Evaluation on Mini-BESTest

  12 weeks

• Functional balance and gait on Timed Up and Go test (TUG)

  12 weeks

• Quality of life on PDQ-39 Questionnaire

  12 weeks

• Functional balance on Dynamic Posturography

  12 weeks

Study Arms (3)

Gym Group

EXPERIMENTAL

With gym equipments, twice per week for 12 weeks.

Other: Gym Group

Free Weights Group

ACTIVE COMPARATOR

With dumbbells, elastics, twice per week for 12 weeks.

Other: Free Weights Group

Control Group

PLACEBO COMPARATOR

The control group will be instructed to perform stretching exercises at home in the same 12-week period, according to an illustrated booklet.

Other: Control Group

Interventions

Gym Group OTHER

Patients from Gym Group will perform a strengthening program of 45 minutes sessions, twice a week in a 12-week period. The initial load is established as 60% of one-repetition maximum strength test (1RM) applied for each exercise at the beginning of program. Patients will be encouraged to perform 3 sets of 8 to 12 repetitions. All subjects will be instructed to rest for 30-60 second intervals between sets.

Gym Group

Free Weights Group OTHER

Patients from Free Weights Group will perform a strengthening program of 45 minutes sessions, twice a week in a 12-week period. The program aim to recruit the same muscles requested in Gym Group. Investigators will apply six different exercises with patients lying supine,standing in stance, sitting and in four points kneeling. All exercises aim to strengthen abdominal muscles, trunk extensors, gluteus, quadriceps and scapula adductors. Patients will perform 3 sets of 8 to 12 repetitions, the load will be offered with dumbbells, elastics with different resistances and anklets.

Free Weights Group

Control Group OTHER

All three groups will be instructed to perform stretching exercises of trunk, leg and shoulder muscles, according to an illustrated booklet. Only the Control Group patients will be instructed to perform stretching exercises at home in the same 12-week period.

Control Group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Department of Neurology of University of Sao Paulo

São Paulo, 05403010, Brazil

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: 38588457 DERIVED

• 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: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Egberto Reis Barbosa, MD, PhD

  Department of Neurology, Clinics Hospital of University of São Paulo Faculty of Medicine, São Paulo, Brazil.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: February 4, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: October 8, 2018
• Last Updated: April 18, 2019

Record last verified: 2016-10

Locations

BR (1)