NCT03343574

Cardiovascular Effects of Exercise in Patients With Parkinson's Disease

Status unknown NA Last updated 12 March 2024

What this trial tests

NA trial testing Abdominal Strengthening Exercise in Parkinson Disease in 300 participants. Status unknown.

Timeline

1 December 2017

Primary endpoint
30 August 2020

28 November 2024

Quick facts

Lead sponsor	Faizan Ahmed
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	1 December 2017
Primary completion	30 August 2020
Estimated completion	28 November 2024
Sites	1 location across Canada

Drugs / interventions tested

• Abdominal Strengthening Exercise

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →
• Orthostatic Hypotension — all drugs for Orthostatic Hypotension →

Sponsor

Faizan Ahmed

Who can join

Adults 40 to 90, any sex, with Parkinson Disease or Orthostatic Hypotension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Abnormalities in the regulation of cardiovascular system due to autonomic nervous system (ANS) dysfunction may lead to a sudden decline in blood pressure (BP) upon standing, sitting or performing activities/exercises in patients with Parkinson's Disease (PD). This sudden decline in BP is known as 'orthostatic hypotension' (OH). OH may cause dizziness and/or black-outs, which may increase the risk of falls. As falls are potentially dangerous and disabling, it is important to prevent their occurrence. Keeping BP within normal range upon change of posture or with activities is therefore of great significance. Pooling of blood in the abdominal blood vessels may be one of the reasons for OH to happen. This research focuses on strengthening the weak abdominal muscles of the participants so that the compressive action of these muscles can help decrease such pooling. Therefore, the researchers hypothesize that strengthening the abdominal muscles shall prove to be helpful in controlling orthostatic hypotension by preventing a sudden decline in blood pressure of the participants upon assumption of upright posture. The secondary hypothesis is that there exists a significant difference in the response of the cardiovascular system to a variety of postures/activities/exercises when patients of PD having cardiovascular autonomic dysfunction are compared with patients of PD with normal ANS function.

This study has two parts - stage 1 and stage 2. Only stage 2 is a randomized controlled trial. Stage 1 involves testing the functional integrity of the autonomic nervous system, and observation of the cardiovascular responses of the participants to different postures/activities/exercises and to the use of an abdominal binder (which is a compressive garment worn around the abdomen). Findings of stage 1 shall help the researchers better understand the cardiovascular abnormalities present in such patients at rest and with activity. Stage 2 involves strength training for the abdominal muscles that is to be done by the participant at her/his residence for a period of 3 months followed by a second round of autonomic function testing and observation of the cardiovascular responses to the use of abdominal binder. Findings of stage 2 shall help the researchers determine if strength training of the abdominal muscles can be a useful strategy to counter the cardiovascular abnormalities found in the participants during the testing in stage 1.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis.
   Ernst M, Folkerts AK, Gollan R, Lieker E, et al · · 2023 · cited 110× · PMID 36602886 · DOI 10.1002/14651858.cd013856.pub2
2. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis.
   Ernst M, Folkerts AK, Gollan R, Lieker E, et al · · 2024 · cited 37× · PMID 38588457 · DOI 10.1002/14651858.cd013856.pub3
3. Advances in the Pharmacological and Non-pharmacological Management of Non-motor Symptoms in Parkinson's Disease: An Update Since 2017.
   Wamelen DJV, Rukavina K, Podlewska AM, Chaudhuri KR. · · 2023 · cited 22× · PMID 35293295 · DOI 10.2174/1570159x20666220315163856