Parkinson DiseaseNCT02674724
The Effect of Resistance Training in Parkinson Disease: A Pilot Study
A study testing Gym Group and Free Weights Group in people with Parkinson Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Gym Group and Free Weights Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to 8 Oct 2018
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 11Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Department of Neurology of University of Sao Paulo
São Paulo, 05403010
About this study
Official title: The Effect of Resistance Training on Balance in Patients With Parkinson Disease: A Pilot Study
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.
Read the detailed 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.
- Conditions
- Parkinson Disease
- Being tested
- Gym Group, Free Weights Group, Control Group
- Keywords
- Resistance Training, Postural Balance, Exercise
- 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.
Gym GroupOther
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.
Free Weights GroupOther
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.
Control GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Gym Group | Experimental | With gym equipments, twice per week for 12 weeks. Receives: Other: Gym Group |
| Free Weights Group | Active comparator | With dumbbells, elastics, twice per week for 12 weeks. Receives: 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
Balance on Berg Balance Scale
Berg Balance Scale is used to assess balance and falls in elderly using different tasks. It consists of 14 tasks scoring from zero to four, zero means that the patient is unable to perform the task and four means that the task is performed independently.
Measured: 12 weeks
Balance Evaluation on Mini-BESTest
The Mini-BESTest contains 14 items that assess dynamic balance focusing on anticipatory postural adjustments, postural responses, sensory orientation and stability in gait. Items are scored from 0 to 2 (normal performance in balance).
Measured: 12 weeks
Functional balance and gait on Timed Up and Go test (TUG)
The TUG test measures individual speed while performing the sequence: rising from a chair, walking for three meters of distance, turning around and returning to the starting position, sitting on a chair. When the examination exceeds 13 seconds, patients have higher risk of falls.
Measured: 12 weeks
Quality of life on PDQ-39 Questionnaire
The PDQ-39 assess quality of life of Parkinson's disease patients over the last month. Contains 39 items and eight dimensions (Mobility, Activities of daily living, Emotional well-being, Stigma, Social support, Cognitions and Bodily discomfort).
Measured: 12 weeks
Functional balance on Dynamic Posturography
Dynamic posturography is a quantitative method to assess balance. This system have sensors located below two platforms and measures vertical and horizontal forces produced by the center of gravity during a pre-determined task (sit to stand, tandem walk and step over).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2018
- Study completion8 Oct 2018
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.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Egberto Reis Barbosa, MD, PhD, Study director, Department of Neurology, Clinics Hospital of University of São Paulo Faculty of Medicine, São Paulo, Brazil.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674724
- Sponsor's protocol ID
- Department of Neurology
- Status last verified
- Oct 2016
- First submitted
- 14 Jan 2016
- Last updated
- 18 Apr 2019
- 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 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Resistance Training on Balance in Patients With Parkinson Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT02674724
- Acronym / sponsor ID
- Department of Neurology
- Conditions
- Parkinson Disease
- Keywords
- Resistance Training, Postural Balance, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 4 Feb 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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gym Group | Experimental | Other: Gym GroupWith gym equipments, twice per week for 12 weeks. |
| Free Weights Group | Active comparator | Other: Free Weights GroupWith dumbbells, elastics, twice per week for 12 weeks. |
| Control Group | Placebo comparator | Other: Control GroupThe control group will be instructed to perform stretching exercises at home in the same 12-week period, according to an illustrated booklet. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Gym GroupPatients 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. | Other | Gym Group |
| Free Weights GroupPatients 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. | Other | Free Weights Group |
| Control GroupAll 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. | Other | Control Group |
Primary outcome
Postural sway on Static Posturography
Time frame: 12 weeks
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.
5 secondary outcomes
Balance on Berg Balance Scale
Time frame: 12 weeks
Balance Evaluation on Mini-BESTest
Time frame: 12 weeks
Functional balance and gait on Timed Up and Go test (TUG)
Time frame: 12 weeks
Quality of life on PDQ-39 Questionnaire
Time frame: 12 weeks
Functional balance on Dynamic Posturography
Time frame: 12 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 18 Apr 2019.
- 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.
Egberto Reis Barbosa, MD, PhD study director
Department of Neurology, Clinics Hospital of University of São Paulo Faculty of Medicine, São Paulo, Brazil.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gym Group and Free Weights Group in people with Parkinson Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 11 inclusion and 1 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 18 Apr 2019. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Postural sway on Static Posturography (time frame: 12 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 NCT02674724, 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 18 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.