HIFT in People With Parkinson's Disease

Neurodegenerative Diseases Clinical Trial

Official title:

Effectiveness of a HIFT Program on Cognitive and Functional Performance in People With Parkinson's Disease: Randomised Pilot Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05482776
• Other study ID #: Randomized pilot trial
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 17, 2022
• Est. completion date: July 2023

Study information

• Verified date: July 2022
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Parkinson's disease (PD) is a progressive and chronic neurodegenerative disease, which presents signs and symptoms both motor (impaired gait, posture, balance, etc.) and cognitive (memory loss, dementia, etc.), all of which cause disability and assuming a high economic cost. Currently, there are already certain authors who have shown how a high-intensity interval training (HIIT) protocol produces improvements in cognitive and physical performance in healthy adults and in people with multiple sclerosis. However, another modality has been created, such as high-intensity functional training (HIFT), which can benefit different populations, both healthy and pathological, due to the multimodal nature of the exercises. These are prescribed knowing the target group and involve the whole body using universal motor recruitment patterns in multiple planes of movement such as squats. The main hypothesis of the study is that high-intensity functional training (HIFT), at a motor and cognitive level, provides a greater benefit than conventional programs of strength, balance and cognition, on the functionality and cognitive capacity of people with Parkinson's disease.

Description:

Parkinson's disease (PD) is a progressive and chronic neurodegenerative disease, which presents signs and symptoms both motor (impaired gait, posture, balance, etc.) and cognitive (memory loss, dementia, etc.), all of which are causing disability and assuming a high economic cost. This pathology is characterized by the destruction, due to still unknown causes, of the dopaminergic neurons, which are found in a region of the brain called the basal ganglia, specifically in a part of the brainstem called the substantia nigra. These neurons act in the central nervous system and use dopamine as primary neurotransmitter, responsible for transmitting the necessary information for the correct control of movements. For this reason, the result of destruction involves slowing of movements along with lack of coordination. These processes cause multiple deficits in higher cortical functions, affecting the motor and cognitive capacity of the individual and, therefore, negatively affecting the execution of both basic and instrumental daily activities. PD is the second most common neurodegenerative disease after Alzheimer's and it presents in both sexes in a similar way, with a slight predominance in men. The World Health Organization already estimated in 2005 a global incidence of 4.5-19 new cases per year per 100,000 inhabitants and a global prevalence of 100-200 cases per 100,000 inhabitants, while a more recent report published by the European Parkinson's Disease Association estimates a worldwide prevalence for the year 2030 of between 8.7 and 9.3 million people. 70% of patients are people over 65 years of age, and 15% of all those affected are adults under 45 years of age. As a general rule, PD affects 1% of the population over 60 years of age, 2% of those over 70 years of age, and 3% of those over 803. Due to all the physical and psychological consequences that can occur, the economic impact of this type of neurodegenerative pathology in the family nucleus is really great. The average annual expenditure per family unit for the different neurological pathologies is 13,063 euros. On the PD, the amount is established up to the figure of 9,219 euros per year. This expense is usually progressive according to the degree of advancement of the disease, averaging an expense of 7,146 euros in the incipient phase of the disease, going through 8,491 euros in the intermediate phase and reaching 14,443 euros in the advanced phase. From all this it can be deduced that families are currently the main providers of support services for this type of patient, causing a very high cost for them. In this sense, it is important to highlight that a large percentage of patients have had to change their address or have had to carry out reforms to adapt the home to their situation (bathroom, adjustable bed, crane, restraints or barriers for the bed, among others).

Currently, there are already certain authors who have shown how a high intensity interval training (HIIT) protocol produces improvements in cognitive and physical performance in healthy adults and in people with multiple sclerosis. These training programs are of a unimodal nature, that is, specific exercises for a specific joint and muscle group such as jumping, rowing, running or lifting weights, among others. However, another modality has been created, such as high-intensity functional training (HIFT), which can benefit different populations, both healthy and pathological, due to the multimodal nature of the exercises. These are prescribed knowing the target group and involve the whole body using universal motor recruitment patterns in multiple planes of movement such as squats. Thanks to multimodality, more aspects such as agility, coordination and precision of movements are worked on compared to unimodal HIIT programs that make this relevant work difficult in a person's daily life. However, the functionality of the exercises provides added value, since it improves the motivational factor, which in turn increases adherence to the program and the obtaining of health benefits. The current study aims to demonstrate the effectiveness of a HIFT training protocol in a specific population, such as people with Parkinson's disease.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of Parkinson's disease.

2. Phase I or II (Hoehn - Yahr Scale).

3. Independent ambulation for 10 consecutive minutes.

4. Perform physical exercise on a regular basis.

Exclusion Criteria:

1. Medical contraindication for physical activity, deafness or limited hearing and very low vision or blind.

2. Vestibular disorders that compromise balance.

3. Serious psychotic or cognitive disorder.

4. Decompensation or changes in medication.

5. Surgical intervention in the last 6 months.

6. Sedentary people

Related Conditions & MeSH terms

• Neurodegenerative Diseases
• Parkinson Disease

Intervention

Other:
• High intensity functional training
HIFT is an exercise modality that emphasizes functional movements through exercises that involve a large amount of muscle mass and that can be adapted to the level of physical condition of each subject. Although it has similarities and is compared to HIIT, they are different. In this discipline, functional exercises with an external load such as squats, pull-ups, or functional exercises with our own weight, are mixed with other aerobics such as running, rowing or cycling. This mix results in a high-intensity training that improves parameters of physical condition in general and performance.
• classic training group
This intervention consists of carrying out their conventional weekly physiotherapy training sessions where strength, coordination and balance are trained.

Locations

Country	Name	City	State
Spain	Asociación de Esclerosis Múltiple de Ibiza y Formentera (AEMIF)	Ibiza	Islas Baleares

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Campbell E, Coulter EH, Paul L. High intensity interval training for people with multiple sclerosis: A systematic review. Mult Scler Relat Disord. 2018 Aug;24:55-63. doi: 10.1016/j.msard.2018.06.005. Epub 2018 Jun 13. — View Citation

Chan WLS, Pin TW. Reliability, validity and minimal detectable change of 2-minute walk test, 6-minute walk test and 10-meter walk test in frail older adults with dementia. Exp Gerontol. 2019 Jan;115:9-18. doi: 10.1016/j.exger.2018.11.001. Epub 2018 Nov 10 — View Citation

Coetsee C, Terblanche E. The effect of three different exercise training modalities on cognitive and physical function in a healthy older population. Eur Rev Aging Phys Act. 2017 Aug 10;14:13. doi: 10.1186/s11556-017-0183-5. eCollection 2017. — View Citation

de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006 Jun;5(6):525-35. doi: 10.1016/S1474-4422(06)70471-9. — View Citation

Weintraub D, Moberg PJ, Duda JE, Katz IR, Stern MB. Effect of psychiatric and other nonmotor symptoms on disability in Parkinson's disease. J Am Geriatr Soc. 2004 May;52(5):784-8. doi: 10.1111/j.1532-5415.2004.52219.x. — View Citation

Wens I, Dalgas U, Vandenabeele F, Grevendonk L, Verboven K, Hansen D, Eijnde BO. High Intensity Exercise in Multiple Sclerosis: Effects on Muscle Contractile Characteristics and Exercise Capacity, a Randomised Controlled Trial. PLoS One. 2015 Sep 29;10(9) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Proportion of randomized participants relative to the number of screened participants. Feasibility criteria > 75 %	Baseline
Primary	Consent rate	Proportion of participants who provide consent relative to the number approached for participation. Feasibility criteria > 70%	Baseline
Primary	Adverse effects rate	Proportion of participants who suffered falls, fatigue or situations that prevent them from continuing with the training. feasibility criteria < 30 %	through intervention completion, an average of 11 weeks
Primary	Trial completion rate	Proportion of randomized participants who complete the trial. Feasibility criteria > 80 %	11 weeks
Primary	Training completion rate	Proportion of training sessions carried out with respect to the total.Feasibility criteria >70 %	10 weeks
Primary	Divergent treatment decision rate	Proportion of exercises modified based on risk of falls. Feasibility criteria < 30 %	10 weeks
Primary	Assessment test performance ratio	Proportion of patients able to perform all screening tests.Feasibility criteria >85 %	11 weeks
Secondary	Mini Mental State Examination (MMSE)	It is a brief test that assesses cognitive function. The questions included in the test attempt to examine various areas of cognitive function: orientation, registration, concentration, memory, language, and copying a figure. The MMSE total score is widely accepted as an indicator of the severity of cognitive impairment. Sensitivity is 87% and specificity is 82% in detecting dementia. Likewise, the values obtained in test-retest, 0.89, and from the inter-rater, 0.82, have also shown that MMS is an effective instrument in the English language. Concurrent validity has been tested with extensive neuropsychological tests and also in longitudinal studies. The test has been widely used in clinical practice and in research.	Baseline and 11 week
Secondary	Trail making Test (TMT)	The test with part A and B measures visual search, scanning, processing speed, mental flexibility and executive functions. In Part A, the subject uses a pencil to connect a series of 25 circled numbers in numerical order on a sheet of paper with the prompt to do so in the shortest time possible. This makes it possible to accurately measure search tools and visual attention and psychomotor speed. In part B, a similar execution is required, with the exception that the person must alternate the sequence of numbers from 1 to 13 with letters from "A" to "L". In this way, we can obtain data on executive control, cognitive flexibility and alternation. The evaluated person is timed, obtaining the resulting time. If the examiner notices an error in the order of the lines drawn, she must interrupt the subject and correct the error without stopping the stopwatch during the correction.	Baseline and 11 week
Secondary	Short physical performance battery (SSPB)	The test includes 3 spheres as described below: Balance test A. Stand with feet together side by side B. Semi-tandem C. Full tandem; Walking speed test: Walk 4 meters and record the time.; Chair rise test: Sit down and get up from the chair 5 times and record the time spent.; Each test is scored from 0 to 4. The total score ranges from 0 to 12 points.	Baseline and 11 week
Secondary	2 minute walk test (2-MWT)	The 2-MWT is a simple, inexpensive, and easy-to-administer test that consists of measuring the maximum distance that the patient is able to walk in 2 minutes, in a short walk in a corridor, simultaneously evaluating the heart rate, the saturation of oxygen and the degree of dyspnea using the Borg scale. Its physiological basis is that the distance achieved on a flat course during the defined time (2 minutes) is an expression of the individual's capacity for submaximal exercise, which allows an evaluation of this capacity in different respiratory pathologies. The 2-MWT influences, in addition to an underlying cardio-respiratory pathology, motivational and musculoskeletal factors that provide a global assessment of exercise capacity and can reflect the daily activity of patients better than other laboratory tests.	Baseline and 11 week
Secondary	Barthel index	It was first described by Mahoney and Barthel in 1965 and is widely used by clinicians and researchers. The Barthel Index is defined as a generic measure that assesses the patient's level of independence with respect to performing some activities of daily living (ADL), through which different scores and weights are assigned according to the ability of the examined subject to carry out carry out these activities. The values assigned to each activity are based on the time and amount of physical assistance required if the patient is unable to perform that activity. It is made up of ten basic activities that include feeding, dressing and undressing, washing, using the toilet, urination control, stool control, transfers, use of personal hygiene, going up and down stairs and walking. The scores range from 0 to 10 points, passing through 5. 0 is totally dependent on the third person, 5 means that he needs some help and 10 is totally independent.	Baseline and 11 week
Secondary	Borg scale	It is a standardized and validated visual analog scale in Spanish, quick and easy to apply, which allows graphically evaluating the subjective perception of respiratory distress or physical effort exerted. The Borg scale has been used since the 1970s and the modified one since the 1980s, which has a range from 0 to 10. The scale determines the intensity of dyspnea and has a written expression added to the number, which helps to categorize the sensation of dyspnea of the subject to whom the test is performed. The result is recorded and coded. The interval between the ranges of the scale increases progressively, number 10 shows the greatest perception of dyspnea (of effort). The modified Borg scale is easy to use if the patient is properly instructed.	through intervention completion, an average of 11 weeks

External Links

•   Novel, high-intensity exercise prescription improves muscle mass, mitochondrial function, and physical capacity in individuals with Parkinson's disease
•   Reference values of the Short Physical Performance Battery for patients aged 70 and over in primary health care
•   Reliability, validity and minimal detectable change of 2-minute walk test, 6- minute walk test and 10-meter walk test in frail older adults with dementia