The Effects on Physical Activity on Mitochondrial Function in Skin Fibroblasts in Patients With Parkinson's Disease. - Clinical Trial for Parkinson's Disease | NCT05963425

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Physical activity

usual clinical practice

About this trial

This is an interventional supportive care trial for Parkinson's Disease focused on measuring Parkinson's Disease, Physical Activity, Mitochondrial Function, Skin Fibroblasts

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with a medical diagnosis of idiopathic PD, Hoehn and Yahr scale stages of I-III. Patients who score ≥26 on the Montreal Cognitive Assessment (MoCA). Patients who have signed the IC. Patients with stable medication. Age between 50 and 70 years, and able to walk independently for 6 minutes. Exclusion Criteria: Patients with a pathology other than idiopathic PD. Patients with cognitive impairment (MoCA <26 points). Patients with uncontrolled cardiovascular disease, visual impairment, or recent musculoskeletal disorders in the extremities. Patients who are performing another therapeutic exercise protocol. Patients who have undergone surgery to influence any symptom from the PD.

Sites / Locations

Vall Hebron Institut de RecercaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Physical activity: basic physical training (BPT)

Physical activity: BPT combined with functional exercises

Control

Arm Description

Exercises will target the large muscle groups, with a component/emphasis on the eccentric phase of concentration. The kBox4 Platform (Exxentric AB), a device designed to maximize performance and training outcomes, will be used to enhance the eccentric phase of the exercises. kBox4 is controlled by a specific program, Kmeter, which records and stores all the information (duration, intensity, repetitions, etc.) of each movement. Exxentric kBox4 will be adapted with special harnesses, insurances on the wall and in front of support bars, according to the needs of the patients. In addition to the major muscle groups, specific attention will be given to the key muscles involved in the gait cycle, such as the tibialis anterior, medial gastrocnemius, rectus femoris, and hamstrings, from a biomechanical perspective.

In addition to the BPT program (which includes the transverse focus on strength and resistance exercises), this intervention group will incorporate functional exercises that involve dual task training. The dual task training can encompass both motor-motor and motor-cognitive activities. This means that coordinated exercises will be performed, with cognitive activities introduced at the extremes of the movement. This approach ensures engagement of both physical and cognitive abilities during the PA sessions.

Participants in the control group will maintain their regular daily routines throughout the study period.

Outcomes

Primary Outcome Measures

Change in oxygen consumption rate

Oxygen uptake (VO2, mlkg-1min-1) measured by Seahorse XFe96

Change in ATPmax levels

Maximal mitochondrial ATP production rates measured by Seahorse XFe96

Secondary Outcome Measures

Non-motor and motor function

non-motor and motor experiences of daily living and motor complications measured by the MDS-Sponsored Revision of the UPDRS (MDS-UPDRS) questionnaire

Sleepness

Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire

Mobility

clinical performance-based measure of lower extremity function, mobility and fall risk, measured by the Timed Up and Go Test (TUG) questionnaire

Cognitive aspects

Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA)

Mood

Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire

Non-motor and motor function

non-motor and motor experiences of daily living and motor complications measured by the MDS-Sponsored Revision of the UPDRS (MDS-UPDRS) questionnaire

Sleepness

Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire

Mobility

clinical performance-based measure of lower extremity function, mobility and fall risk, measured by the Timed Up and Go Test (TUG) questionnaire

Cognitive aspects

Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA)

Mood

Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire

Full Information

NCT ID

NCT05963425

First Posted

July 12, 2023

Last Updated

October 6, 2023

Sponsor

University Ramon Llull

Collaborators

University of Coimbra, Hospital Vall d'Hebron

1. Study Identification

Unique Protocol Identification Number

NCT05963425

Brief Title

The Effects on Physical Activity on Mitochondrial Function in Skin Fibroblasts in Patients With Parkinson's Disease.

Acronym

PARKEX

Official Title

The Effects on Physical Activity on Mitochondrial Function in Skin Fibroblasts in Patients With Parkinson's Disease: a Study Protocol.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2023 (Actual)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Ramon Llull

Collaborators

University of Coimbra, Hospital Vall d'Hebron

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

The aim of this study is to investigate the effect of physical activity on mitochondrial function in skin fibroblasts in patients with Parkinson's disease.

Detailed Description

A randomized double-blind clinical trial will be conducted to study the effects of physical activity on mitochondrial function in skin fibroblasts in patients with Parkinson's disease. It is an intervention study, and twenty-four patients will be needed. Once the subjects have been selected, they will be randomly assigned into three groups (eight patients in each group). The first group will perform basic physical training (BPT) based on strength and resistance, the second group will perform BPT combined with functional exercises (BPTFE) with cognitive and motor training, and the third group will not carry out any activity program, serving as control. The interventions will last 60 minutes, with a frequency of 3 times a week, during 16 weeks. The control group will receive 4 months of PA from the program that has obtained the best results,in terms of symptoms and quality of life, after the last evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

Parkinson's Disease, Physical Activity, Mitochondrial Function, Skin Fibroblasts

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Physical activity: basic physical training (BPT)

Arm Type

Experimental

Arm Description

Exercises will target the large muscle groups, with a component/emphasis on the eccentric phase of concentration. The kBox4 Platform (Exxentric AB), a device designed to maximize performance and training outcomes, will be used to enhance the eccentric phase of the exercises. kBox4 is controlled by a specific program, Kmeter, which records and stores all the information (duration, intensity, repetitions, etc.) of each movement. Exxentric kBox4 will be adapted with special harnesses, insurances on the wall and in front of support bars, according to the needs of the patients. In addition to the major muscle groups, specific attention will be given to the key muscles involved in the gait cycle, such as the tibialis anterior, medial gastrocnemius, rectus femoris, and hamstrings, from a biomechanical perspective.

Arm Title

Physical activity: BPT combined with functional exercises

Arm Type

Experimental

Arm Description

In addition to the BPT program (which includes the transverse focus on strength and resistance exercises), this intervention group will incorporate functional exercises that involve dual task training. The dual task training can encompass both motor-motor and motor-cognitive activities. This means that coordinated exercises will be performed, with cognitive activities introduced at the extremes of the movement. This approach ensures engagement of both physical and cognitive abilities during the PA sessions.

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Participants in the control group will maintain their regular daily routines throughout the study period.

Intervention Type

Other

Intervention Name(s)

Physical activity

Other Intervention Name(s)

Exercise

Intervention Description

This physical activity program will be based only on the work of basic physical traininig, in which specifically and mainly the strength and resistance will be worked, but also flexibility

Intervention Type

Other

Intervention Name(s)

usual clinical practice

Intervention Description

usual clinical practice

Primary Outcome Measure Information:

Title

Change in oxygen consumption rate

Description

Oxygen uptake (VO2, mlkg-1min-1) measured by Seahorse XFe96

Time Frame

Beginning of the study and after 4 months

Title

Change in ATPmax levels

Description

Maximal mitochondrial ATP production rates measured by Seahorse XFe96

Time Frame

Beginning of the study and after 4 months

Secondary Outcome Measure Information:

Title

Non-motor and motor function

Description

non-motor and motor experiences of daily living and motor complications measured by the MDS-Sponsored Revision of the UPDRS (MDS-UPDRS) questionnaire

Time Frame