Characterising Physiological Resilience in People With Parkinson's Disease

NCT07013513 | Not Yet Recruiting

• 1 other identifier: FMHS 82-0225
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease (PD) is a condition that affects movement and gets worse over time. It is more common in older adults. People with PD may have symptoms like shaking, stiff muscles, slow movement, and trouble with balance. They may also experience other issues like pain, depression, anxiety, and memory problems, which can make daily life harder. Physiological resilience is the body's ability to recover or stay strong despite challenges like aging or illness. People with low resilience may struggle to cope with illness, become less active, and have a higher risk of weakness or hospitalization. Since both PD and low resilience are more common in older adults, understanding how PD affects resilience can help improve care. This study will look at resilience in people with PD by measuring heart, lung, muscle, coordination, memory, and thinking abilities. It will also compare two types of single-session aerobic exercise-cycling and walking on a treadmill-regarding participants' perspectives. Participants will be randomly chosen to do one of these exercises for 40 minutes at a moderate level. Afterward, they will share their thoughts on how enjoyable and comfortable the exercise was and whether they would continue doing it. Aerobic exercise is often recommended for people with PD, but it is unclear which type is best for people with PD and which type is mostly preferred by participants with PD. The results of this study will help practitioners make better exercise recommendations for people with PD, leading to better symptom management and a higher quality of life.

Conditions

Parkinson's Disease (PD)

Keywords

Parkinson's Disease, elderly, resilience, characterisation, aerobic exercise, feasibility

Outcome Measures

Primary Outcomes (13)

• Body mass assessment

  Bioelectrical impedance analysis (BIA) will be used for this. BIA is simple to use, places a minimal burden on individuals, uses lightweight and inexpensive equipment, and, most significantly, provides no radiation risk compared to many other methods. It is also found feasible and reliable for the measurement of muscle mass for adults in clinical settings.

  on the assessment day (a single time point)

• Muscle mass assessment

  Muscle thickness, pennation angle, and fascicle length of vastus lateralis will be measured on ultrasound. Ultrasonography is also a technology that is portable, safe, and clearly distinguishes between muscle and subcutaneous fat tissues as well as a valid and novel tool for muscle mass assessment.

  on the assessment day (a single time point)

• Muscle strength with maximum voluntary contraction of knee extension

  Maximum voluntary contraction is a standardised technique for assessing muscle strength. Knee extension strength will be measured with an isometric dynamometer.

  on the assessment day (a single time point)

• Handgrip strength assessment

  Isometric hand grip strength is closely correlated with the strength of the muscles in the lower extremities, the torque of the knee, and poor mobility is clinically indicated by low handgrip strength. Higher values mean better results. It will be assessed with a dynamometer.

  on the assessment day (a single time point)

• Surface Electromyography for vastus lateralis, including neuromuscular tracking tasks for knee extension

  Muscle contraction is initiated by motor units, which are made up of a motor neuron and the muscle fibers it innervates. When a motor unit fires, it generates a compound action potential composed of the synchronized action potentials of the muscle fibers within that unit. Surface EMG electrodes are placed on the skin and pick up the electrical activity generated by these action potentials, representing the overall muscle activity. Force accuracy is an important parameter since most daily activities are conducted at submaximal levels, where force fluctuation can be observed and reduce the ability to create an intended movement. Participants will be requested to follow a force trace line on a monitor during knee extension. The tasks will be performed at levels relative to the MVC ranging from 10-70% of maximum

  on the assessment day (a single time point)

• Cardiorespiratory fitness assessment via 6-minute walking test (6MWT)

  In the 6MWT, participants are encouraged to walk as much as they can for six minutes along a continuous, interior track that is 30 metres long and has a hard surface. It is a simple, cost-effective, and validated tool in several populations, and it has been frequently used to measure cardiorespiratory fitness as a field test. The distance covered on this test is reported. Higher values mean better results.

  on the assessment day (a single time point)

• Cardiorespiratory fitness assessment via the Ekblom-bak test

  The Ekblom-bak test consists of exercise at one standardized, low work rate followed by a higher, individually set work rate. Both work rates are performed for 4 minutes at a cadence of 60rpm on a cycle ergometer. The individual higher work rate is chosen by the researcher according to the participants' gender, age, and training background. The higher work rate aims to reach the Borg RPE 12-16. Heart rate is measured during the last minute of each work rate (at 3:15, 3:30, 3:45, and 4:00). Then VO2max is estimated with a formula.

  on the assessment day (a single time point)

• Different balance tasks and balance time on a motion platform (FootScan)

  For the balance tests, using a platform (FootScan) that can assess features such as Centre of Pressure (COP) and sway, participants will be asked to stand on both feet and then on one foot with their eyes open and closed. Time to failure (i.e., need to place the second foot on the floor and/or open eyes) will be recorded. A chair will be located behind participants for this assessment and a researcher will remain within touching distance. Participants will only be requested to complete the aspects of this assessment that they feel comfortable doing.

  on the assessment day (a single time point)

• Functional ability assessment via short physical performance battery test

  Short physical performance battery test (SPPB) includes the chair rise, balance, walk and gait speed assessments for functional mobility (24). An overall score is determined on a scale from 0 to 12, with lower scores representing a more severe level of disability and higher scores representing more functionally normal levels.

  on the assessment day (a single time point)

• Functional ability assessment via the Timed up and Go test

  The Timed up and Go test is a tool for assessing lower limb functional ability and its use has been recommended by the literature. The time required to finish the test is commonly utilised as the primary outcome of the evaluation. This test has previously been used in several studies to assess functional ability

  on the assessment day (a single time point)

• Gait analysis with a walking sensor

  For this analysis participants simply have to walk over a biomechanics platform while wearing a walking sensor using their normal gait so that features such as stride length and stride symmetry can be assessed

  on the assessment day (a single time point)

• Cognition assessment via Mini-ACE

  The Mini-ACE is a brief cognitive test that evaluates four main cognitive areas (orientation, memory, language and visuospatial function). Higher values mean better results.

  on the assessment day (a single time point)

• Hand dexterity assessment via 9-hole peg board task

  Manual dexterity is an important ability that affects an individual's independence in activities of daily living and should be measured as a core element. The 9-hole peg test has been shown to be a valid and reliable tool to measure upper extremity dexterity in various groups

  on the assessment day (a single time point)

Secondary Outcomes (4)

• Enjoyment via the Physical Activity Enjoyment Scale on a single-bout aerobic exercise session (either treadmill or cycling)

  on the assessment day (a single time point)

• Tolerability via the Visual Analog Scale

  on the assessment day (a single time point)

• Emotional state assessment via the Feeling Scale

  on the assessment day (a single time point)

• intention to continue exercising assessment via a 7-point Likert scale

  on the assessment day (a single time point)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population will be selected from the community sample at local groups that cater to older persons in general, through our current PPI-E networks, and through nonprofit organisations and charities that assist Parkinson's sufferers. The planned study's benefits, inherent risks, potential adverse events, and anticipated time commitments would all be thoroughly explained to volunteers, along with the methods and protocols that will be used. Interested participants then will be assessed according to the eligibility criteria.

You may qualify if:

• Participants who are willing and able to give informed consent for participation in the study
• Participants who can walk 30 meters with or without walking aids
• Participants who have a confirmed diagnosis of Parkinson's disease by a healthcare professional.

You may not qualify if:

• Cardio- and/or pulmonary diseases except for well-controlled hypertension and asthma
• Severe cognitive impairment/dementia
• Joint disorders preventing exercise participation
• Current or recent (\<2 years) malignancy (excluding minor cancers such as skin cancer, or not receiving chemotherapy or radiotherapy within the last 3 months)

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

The University of Nottingham/Medical School

Derby, Derbyshire, United Kingdom

Location

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Related Links

• Related Info

Study Officials

• Mehmet C Yildirim

  The University of Nottingham

  STUDY DIRECTOR

Central Study Contacts

Bethan E Phillips

CONTACT

+44 (0) 1332 724676; beth.phillips@nottingham.ac.uk

Jemima Collins

CONTACT

mszjtc@exmail.nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Translational Physiology

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 10, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)