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
Verified date | July 2022 |
Source | University of Valencia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Asociación de Esclerosis Múltiple de Ibiza y Formentera (AEMIF) | Ibiza | Islas Baleares |
Lead Sponsor | Collaborator |
---|---|
University of Valencia |
Spain,
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
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 |
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