Exercise Management in Parkinson's Disease

Official title

The Effects of Exercise Management in Parkinson's Disease

Overview

The aim of this study is to examine the benefits that individuals with Parkinson's disease will gain from the rehabilitation program by enabling them to manage their exercise times independently using telerehabilitation method. The main research questions examined in this study are as follows: * Are the improvements in quality of life, walking speed and changes in functionality parameters achieved by individuals with Parkinson's disease through managing their own exercise plans as effective as those achieved through a supervised exercise programme? * Is it effective for Parkinson's patients to manage their own exercise plans in improving their adherence to exercise?

Detailed description

Parkinson's Disease (PD) is a movement disorder characterized by motor and non-motor symptoms, changes in the patient's balance and gait patterns, and a significant impact on daily living activities. Physical therapy and rehabilitation play a crucial role in managing the symptoms resulting from PD. It is known that early participation in a rehabilitation program significantly improves patients' quality of life.

Patients need to incorporate exercise prescriptions designed specifically for them into their lives and participate in a lifelong exercise program. While integrating these exercises into their lives, patients encounter certain barriers and lose their motivation to exercise. These barriers can include transportation, economic problems, time management, and motor and non-motor symptoms.

Home-based exercises and telerehabilitation methods emerge as solutions for dealing with transportation, economic problems, and time management. These methods can be seen as important aids in helping patients develop the habit of exercising.

Patients diagnosed with Idiopathic Parkinson's Disease who meet the inclusion criteria and agree to participate in the study will be included. The demographic information (age, occupation, height, body weight, etc.) and clinical status (duration of diagnosis, medication dosage, etc.) of all participants will be recorded. The Montreal Cognitive Assessment Scale will be used to determine the cognitive level of patients. The motor assessment of patients will be performed using the Cognitive Parkinson's Disease Assessment Scale III. The Montreal Cognitive Assessment Scale will be used to determine the cognitive level of patients. Functional balance and mobility will be assessed using the Timed Up and Go Test and the 10-meter Walk Test. Repetitive movement performance will be assessed using the 5 Repeat Sit-to-Stand Test, and balance level will be assessed using the Activity-Specific Balance Confidence Scale. Quality of life will be assessed using the Parkinson's Disease Quality of Life Questionnaire. Motivation to exercise and self-assessment will be determined using the Behavioral Modifications to Exercise Scale-2. These assessment criteria will be re-evaluated before and after the exercise program. Patients will be given an exercise diary and asked to keep it throughout the program. The System Usability Scale will be used to evaluate the usability of the website developed for this thesis study.

Participants will be randomly assigned to 2 groups. The control group will complete the exercise program assigned to them continuously via the web-based system. The experimental group will complete the exercise program assigned to them at their preferred time within the same day. Exercise programs will be planned for 8 weeks.

Interventions

• Other Telerehabilitation
  The exercises will consist of stretching, strengthening, balance, and neuromotor exercises that the patient can perform independently at home.

Primary outcome measures

• Change in motor impairment [Time frame: Baseline and the end of the 8 weeks exercise program]
• Change in behavioral regulations in exercise [Time frame: Baseline and the end of the 8 weeks exercise program]
• Change in lower extremity power and endurance [Time frame: Baseline and the end of the 8 weeks exercise program]
• Change in walking speed [Time frame: Baseline and the end of the 8 weeks exercise program]
• Change in mobility [Time frame: Baseline and the end of the 8 weeks exercise program]
• Change in body position [Time frame: Baseline and the end of the 8 weeks exercise program]
• Change in quality of life [Time frame: Baseline and the end of the 8 weeks exercise program]

Eligibility criteria

Inclusion criteria

• Diagnosed with Idiopathic Parkinson's Disease by a neurologist according to the UK Parkinson's Disease Association Brain Bank clinical diagnostic criteria
• H\&Y Stage I-III
• Montreal Cognitive Assessment Scale MoCA≥21
• Having the necessary technological devices to participate in telerehabilitation
• Being able to walk 100 meters
• Having at least a primary school diploma

Exclusion criteria

• Presence of a neurological disorder other than Parkinson's disease
• Presence of any cardiopulmonary or musculoskeletal problem that affects gait and balance
• Receiving Deep Brain Stimulation (DBS) treatment or having undergone DBS surgery in the past
• Presence of vision or hearing problems

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Marmara University — Maltepe

Publications

• Franchignoni F, Giordano A, Ronconi G, Rabini A, Ferriero G. Rasch validation of the Activities-specific Balance Confidence Scale and its short versions in patients with Parkinson's disease. J Rehabil Med. 2014 Jun;46(6):532-9. doi: 10.2340/16501977-1808. PMID 24687205
• Huang SL, Hsieh CL, Wu RM, Tai CH, Lin CH, Lu WS. Minimal detectable change of the timed "up & go" test and the dynamic gait index in people with Parkinson disease. Phys Ther. 2011 Jan;91(1):114-21. doi: 10.2522/ptj.20090126. Epub 2010 Oct 14. PMID 20947672
• Dean CM, Richards CL, Malouin F. Walking speed over 10 metres overestimates locomotor capacity after stroke. Clin Rehabil. 2001 Aug;15(4):415-21. doi: 10.1191/026921501678310216. PMID 11518442
• Duncan RP, Leddy AL, Earhart GM. Five times sit-to-stand test performance in Parkinson's disease. Arch Phys Med Rehabil. 2011 Sep;92(9):1431-6. doi: 10.1016/j.apmr.2011.04.008. PMID 21878213
• Goetz CG, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stebbins GT, Stern MB, Tilley BC, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, Van Hilten JJ, LaPelle N. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Process, format, and clini PMID 17115387
• Fahn S. Unified Parkinson's disease rating scale. Recent developments in Parkinson's disease. 1987:153-63.
• Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10. PMID 33848468

Identifiers

NCT: NCT07302386 · 949

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗