Characterising Physiological Resilience in People With Parkinson's Disease

Not yet recruiting

• Conditions: Parkinson's Disease (PD)

• Registration Number: NCT07013513
• Lead Sponsor: University of Nottingham

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.

Detailed Description

Parkinson's is a chronic, progressive, neurodegenerative movement disorder. Both genetic and environmental factors may contribute to the development of Parkinson's in an individual. The onset of PD before the age of 50 is rare but does become more common as people age, affecting \~1% of adults over the age of 60 and 4% of those over 85. The most important motor signs of PD are rest tremor, bradykinesia, rigidity and postural instability. Abnormalities in gait, balance, eye movement, posture, speech, and facial expressions are common. Poor balance, gait disturbance, and impaired mobility are among the most important research priorities identified by people living with PD. Furthermore, people with PD frequently experience non-motor symptoms such as pain, anxiety, depression, dementia, and constipation. Collectively, these symptoms lead to deterioration in quality of life, impaired ability to perform activities of daily living, and reduced functional independence, and motor performance.

Physiological resilience refers to the capacity to retain or regain physical function in the presence of diseases or age-related impairments. Poor resilience may raise the likelihood of being vulnerable to stresses, which could lead to negative functional and clinical consequences like a prolonged course of illness/hospitalization, reduced physical activity, an elevated risk of frailty, and even mortality. It is important to assess older populations' physiological resilience (check their readiness levels for potential future stressors). Since the risk of low resilience and prevalence of PD increase with advanced age, there is a relationship between low physiological resilience and PD due to the fact that it can deteriorate the parameters of resilience. Therefore, it is important to explore the characteristics of physiological resilience in PD populations.

This study will explore the characteristics of physiological resilience in terms of muscle strength, muscle mass, neuromuscular function, functional ability, cardiorespiratory fitness, dexterity, and cognition in people with PD.

Moreover, among the several exercise modalities implemented in the rehabilitation of PD symptoms, aerobic exercise is the most frequently employed and it is also a crucial component of the exercise regimen for people with PD according to European and American guidelines, which has been stated as a beneficial tool to promote physiological resilience at all stages of life. However, there is a lack of information in the literature on which aerobic exercise modality is better for this purpose in people with PD. Beyond the investigation of physiological resilience parameters in individuals with PD, this study will also provide valuable feedback from this population group on two single-bout aerobic exercises (cycling vs treadmill walking). Participants will be randomised to conduct either cycling or treadmill walking. Each of these two aerobic exercise sessions will last for 40 minutes and will be conducted at moderate intensity (estimated according to the heart rate maximum (HRmax)). Having conducted a single-bout aerobic exercise session; participants will be asked to complete scales about 'exercise enjoyment, tolerability, emotional state, and intention to continue exercising' as feedback. This study will inform future guidelines for exercise prescriptions for PD rehabilitation. It will be a cross-sectional study that collects data at a single-time point.

Potential participants identified will be sent the PIS. The study will be explained via email or over the phone by a member of the research team if needed. Participants who are willing to participate in the study will then be invited to attend the Medical school at the Royal Derby Hospital site for a screening session. The study will include two visits: 1) screening day, 2) assessment day. We will have a pre-screening via telephone call or email to check they meet the eligibility criteria: diagnosed with PD, adequately mobile (able to walk 30 meters), and willing to take part. If these initial points are satisfied, then participants will be invited for a screening session.

At the screening session, written informed consent will be received from the participants since it is an essential legal and ethical consideration before conducting tests for exercising in health, fitness, and clinical settings. Following completion of the consent process, heart rate, blood pressure, ECG, and medical history including previous and current medication usage will be collected via a screening sheet. The unified Parkinson's disease rating scale (UPDRS) will be used to evaluate the severity of PD. This scale consists of 42 items divided into four categories: Section I (mentation, behaviour, and mood), Section II (activities of daily living, graded as "on" or "off"), Section III (motor exam), and Section IV (complications). The UPDRS battery also includes the Hoehn and Yahr, and the Schwab and England scales.

Participants will have a chance to ask any questions about the study protocol, screening, and eligibility assessments. Screening results will be discussed with a clinician to decide participants' eligibility. If an abnormal screening result is encountered, this will be discussed with the participant, and their GP will be informed in writing. Only those parts of the assessment visit that participants feel comfortable performing will be required of. Participants will have direct supervision from a member of the research team at all times.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-01
• Study First Submitted QC: 2025-06-01
• Last Update Submitted: 2025-06-01
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body mass assessment	on the assessment day (a single time point)	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.
Muscle mass assessment	on the assessment day (a single time point)	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.
Cardiorespiratory fitness assessment via the Ekblom-bak test	on the assessment day (a single time point)	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.
Muscle strength with maximum voluntary contraction of knee extension	on the assessment day (a single time point)	Maximum voluntary contraction is a standardised technique for assessing muscle strength. Knee extension strength will be measured with an isometric dynamometer.
Handgrip strength assessment	on the assessment day (a single time point)	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.
Surface Electromyography for vastus lateralis, including neuromuscular tracking tasks for knee extension	on the assessment day (a single time point)	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
Cardiorespiratory fitness assessment via 6-minute walking test (6MWT)	on the assessment day (a single time point)	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.
Different balance tasks and balance time on a motion platform (FootScan)	on the assessment day (a single time point)	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.
Functional ability assessment via short physical performance battery test	on the assessment day (a single time point)	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.
Functional ability assessment via the Timed up and Go test	on the assessment day (a single time point)	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
Gait analysis with a walking sensor	on the assessment day (a single time point)	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
Cognition assessment via Mini-ACE	on the assessment day (a single time point)	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.
Hand dexterity assessment via 9-hole peg board task	on the assessment day (a single time point)	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

Secondary Outcome Measures

Name	Time	Method
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)	The Physical Activity Enjoyment Scale (PACES) is a questionnaire used to measure the extent to which individuals enjoy engaging in physical activity. It's a tool for understanding the positive emotional experience associated with exercise, which can be a key factor in promoting long-term adherence to physical activity programs. Responses will be indicated indicated on a Likert scale with 18-item version, with higher scores representing greater enjoyment.
Tolerability via the Visual Analog Scale	on the assessment day (a single time point)	The Visual Analog Scale (VAS) is a method for measuring the intensity of a subjective experience, like pain or discomfort, by having individuals mark a line to indicate their level. It is a continuous scale, typically from 0 to 100, where 0 represents "no pain" and 100 represents "worst possible pain". Tolerability, in this context, often refers to how well a patient can bear a treatment or condition based on the VAS score.
Emotional state assessment via the Feeling Scale	on the assessment day (a single time point)	The Feeling Scale (FS) is used to measure the emotional state during an exercise session by assessing the pleasure or displeasure experienced by the individual. It is an 11-point bipolar scale ranging from -5 (very bad) to +5 (very good), with verbal anchors like "very bad," "bad," "fairly bad," "neutral," "fairly good," "good," and "very good".
intention to continue exercising assessment via a 7-point Likert scale	on the assessment day (a single time point)	A 7-point Likert scale can be used to assess intention to continue exercising by asking individuals to rate their agreement with statements like "I plan to continue exercising in the next week" or "I am determined to make exercise a regular part of my life."

Trial Locations

Locations (1)

The University of Nottingham/Medical School; 🇬🇧 Derby, Derbyshire, United Kingdom