Home Physiotherapy in Frailty in Patients With Parkinson's Disease

NCT05607862 | Completed

• 1 other identifier: 2022-398 Parkinson´s disease.
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this protocol is to evaluate the effects of a home-based therapeutic exercise program applied in patients with PD to reverse frailty. The design of this study is experimental, prospective, randomized and single blind. The study population that will be part of this study will be men and women with a diagnosis of PD belonging to the Health Area V of the Health Service of the Principality of Asturias, Spain.

Conditions

Parkinson Disease; Physical Therapy Modalities; Frailty

Keywords

Home physiotherapy

Outcome Measures

Primary Outcomes (2)

• Frailty: Fried's Frailty Phenotype:

  Fried's Frailty Phenotype proposed in the Cardiovascular Health Study (Fried et al., 2001) consists of 5 criteria: unintentional weight loss, exhaustion, low physical activity, reduced grip strength, and reduced gait speed. It has a total score ranging from 0 to 5. A frail person is who scores 3 to 5; prefrail when scores 1 to 2, and robust when scores 0.

  Change in frailty of individuals at baseline up to the 8th and 12th week after interventions.

• Frailty: Clinical Frailty Scale.

  The Clinical Frailty Scale (CFS) was proposed in the Canadian Study of Health and Aging (CSHA) (Rockwood et al., 2005). It is a hierarchical scale of 9 levels ranging from 1, the best state of health, to 9, the worst situation: fit, well, well managed, vulnerable, mildly frail, moderately frail, severely frail, very severely frail, terminally ill.

  Change in frailty of individuals at baseline up to the 8th and 12th week after interventions.

Secondary Outcomes (9)

• Comorbidities Charlson Index

  Baseline - 8 weeks - 3 months

• Movement Disorder Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS).

  Baseline - 8 weeks - 3 months

• Cognitive function: Parkinson's Disease Cognitive Rating Scale (PD-CRS).

  Baseline - 8 weeks - 3 months

• Quality of life, PDQ-39

  Baseline - 8 weeks - 3 months

• Short Physical Performance Battery activity level

  Baseline - 8 weeks - 3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will continue with its usual medical-pharmacological treatment, and will also receive a multi-component exercise program and health education guidelines.

Other: Home Physiotherapy Group

Control Group

OTHER

The control group will be given health education guidelines and will continue with their usual medical-pharmacological treatment.

Other: Control Group

Interventions

Home Physiotherapy Group OTHER

The intervention group will receive 2 sessions per week for 8 weeks supervised and assisted by a physiotherapist at the patient's home. Muscle strengthening exercises of the lower and upper limbs, stretching, coordination and balance exercises, gait re-education with the relevant technical aids, a pattern of exercises to be performed daily by the patient and health education guidelines will be carried out.

Intervention Group

Control Group OTHER

The control group will be given health education guidelines and will continue with their usual medical-pharmacological treatment. All patients included in this study will receive physiotherapy treatment, and those in the control group will be treated once the intervention and the post-intervention assessment have been completed.

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, aged 60 years or older, with a diagnosis of PD
• Having frailty or prefrailty according to the Fried scale (1 or 2 prefrailty criteria, 3 or more frailty criteria).
• Stage 1-3 of the Hoehn and Yahr scale.
• Patients who have been referred to the Home Rehabilitation Service of the Instituto de Rehabilitación Astur S.A.
• Obtaining a score higher than 24 points in the Mini Mental State Examination (MMSE).
• Signing the informed consent form.

You may not qualify if:

• Parkinsonisms secondary, plus or atypical (progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration, Lewy body disease).
• Acute disease causing clinical instability.
• Stage 4 and 5 of the Hoehn and Yahr scale.
• Receiving individualized outpatient or home physiotherapy treatment for Parkinson's disease or secondary parkinsonism.
• Patients unable to speak.
• Patients in terminal phase.
• Patient with dementia.

Sponsors & Collaborators

• University of Oviedo: lead

Study Sites (1)

University of Oviedo

Oviedo, Spain

Location

Related Publications (13)

• Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

  PMID: 16129869 BACKGROUND

• Gobbens RJ, van Assen MA, Luijkx KG, Wijnen-Sponselee MT, Schols JM. The Tilburg Frailty Indicator: psychometric properties. J Am Med Dir Assoc. 2010 Jun;11(5):344-55. doi: 10.1016/j.jamda.2009.11.003. Epub 2010 May 8.

  PMID: 20511102 BACKGROUND

• Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

  PMID: 3558716 BACKGROUND

• Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.

  PMID: 19025984 BACKGROUND

• Martinez-Martin P, Frades Payo B. Quality of life in Parkinson's disease: validation study of the PDQ-39 Spanish version. The Grupo Centro for Study of Movement Disorders. J Neurol. 1998 May;245 Suppl 1:S34-8. doi: 10.1007/pl00007737.

  PMID: 9617722 BACKGROUND

• Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

  PMID: 8126356 BACKGROUND

• Pagonabarraga J, Kulisevsky J, Llebaria G, Garcia-Sanchez C, Pascual-Sedano B, Gironell A. Parkinson's disease-cognitive rating scale: a new cognitive scale specific for Parkinson's disease. Mov Disord. 2008 May 15;23(7):998-1005. doi: 10.1002/mds.22007.

  PMID: 18381647 BACKGROUND

• Granger CV, Albrecht GL, Hamilton BB. Outcome of comprehensive medical rehabilitation: measurement by PULSES profile and the Barthel Index. Arch Phys Med Rehabil. 1979 Apr;60(4):145-54.

  PMID: 157729 BACKGROUND

• Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.

  PMID: 5349366 BACKGROUND

• Holden MK, Gill KM, Magliozzi MR, Nathan J, Piehl-Baker L. Clinical gait assessment in the neurologically impaired. Reliability and meaningfulness. Phys Ther. 1984 Jan;64(1):35-40. doi: 10.1093/ptj/64.1.35.

  PMID: 6691052 BACKGROUND

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

• Qutubuddin AA, Pegg PO, Cifu DX, Brown R, McNamee S, Carne W. Validating the Berg Balance Scale for patients with Parkinson's disease: a key to rehabilitation evaluation. Arch Phys Med Rehabil. 2005 Apr;86(4):789-92. doi: 10.1016/j.apmr.2004.11.005.

  PMID: 15827933 BACKGROUND

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 RESULT

MeSH Terms

Conditions

Parkinson Disease; Frailty

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Maria Cruz Sousa Fraguas

  University of Oviedo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Physiotherapist.

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 7, 2022
• Study Start: October 15, 2022
• Primary Completion: November 2, 2023
• Study Completion: February 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

ES (1)