Home Physiotherapy in Frailty in Patients With Parkinson's Disease

NCT ID: NCT05607862

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2024-02-01

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.

Detailed Description

Introduction: Parkinson's disease (PD) is the association of tremor, rigidity, akinesia-bradykinesia and loss of postural reflexes. Non-motor symptoms such as cognitive impairment may also develop. Frailty is a syndrome characterized by a decrease in physiological reserve that results in an individual's increased vulnerability, which can lead to a variety of adverse factors when exposed to stressors. There are three prominent theoretical frameworks for the study of frailty, the physical model developed by Fried et al., the deficit accumulation model by Rockwood et al. and the biopsychosocial model by Gobbens et al. PD and frailty are highly prevalent in older people and are associated with increased morbidity and mortality. Frailty is a reversible condition, especially during the early stages, so early detection is important. Previous studies have been carried out with the application of exercise programs to reverse frailty in older adults, obtaining good results at a physical level.

General objective:

• Evaluate the effects of a therapeutic home exercise program applied in patients with PD to reverse frailty.

Specific objectives:

• Evaluate the effects of a home therapeutic exercise program on motor and non-motor symptoms, as well as on quality of life, balance and gait.
• Identify the characteristics of the patients who obtain the greatest improvement.
• Evaluate the effects of a home therapeutic exercise program after a period of time of three months after the intervention.

Study design: experimental, prospective, randomized and single-blinded.

Study population: The subjects 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

Home Physiotherapy Group

Intervention Type: 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.

Control Group

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

Group Type: OTHER

Control Group

Intervention Type: 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.

Interventions

Home Physiotherapy Group

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 Type: OTHER

Control Group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oviedo

OTHER

Sponsor Role: lead

Responsible Party

María Cruz Sousa Fraguas

Principal Investigator. Physiotherapist.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Cruz Sousa Fraguas

Role: PRINCIPAL_INVESTIGATOR

University of Oviedo

Locations

University of Oviedo

Oviedo, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 16129869 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20511102 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3558716 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19025984 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9617722 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8126356 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18381647 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 157729 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 5349366 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6691052 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1991946 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15827933 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11253156 (View on PubMed)

Other Identifiers

2022-398 Parkinson´s disease.

Identifier Type: -

Identifier Source: org_study_id