Characterising Physiological Resilience in People With Parkinson's Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorUniversity of Nottingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
on the assessment day (a single time point)
2

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.

Time frame
on the assessment day (a single time point)
3

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.

Time frame
on the assessment day (a single time point)
4

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.

Time frame
on the assessment day (a single time point)

Secondary outcomes

1

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

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.

Time frame
on the assessment day (a single time point)
2

Tolerability via the Visual Analog Scale

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.

Time frame
on the assessment day (a single time point)
3

Emotional state assessment via the Feeling Scale

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".

Time frame
on the assessment day (a single time point)
4

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

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."

Time frame
on the assessment day (a single time point)

Other outcomes

Sponsors and contacts

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