Neuropilates Compared to General Exercise Classes in Chronic Stroke

NCT ID: NCT04491279

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2022-01-31

Brief Summary

This is a pilot randomised controlled feasibility study investigating the effects of a neuropilates exercise class compared to a generalised exercise in the post stroke population. This study is being conducted as part of an MSc qualification at the Institute of Technology, Sligo in Ireland. The study will be conducted in conjunction with Sligo University Hospital and it attained ethical approval through the relevant University Hospital Ethics Committee.

Detailed Description

Pilates is an exercise form created by Joseph Pilates in the 1920s. It is a programme of mind-body exercise focusing on strength, core stability, flexibility, muscle control, posture and breathing. Neuropilates is the practice of clinical pilates in patients with a neurological condition. The exercise is ideally led by a clinician with experience and expertise in the area and uses postural, positional and equipment adaptations as necessary to suit the needs of the client. The benefits derived from pilates exercise of balanced strength with improved alignment, postural control and flexibility, could be favourable to post stroke patients who often have one-sided loss of strength and muscle length and subsequent adverse postural adaptations and abnormal movement patterns.

This study aims to investigate the effects of a 6-week neuropilates class in post stroke patients, when compared with a 6-week generalised exercise class. Participants will be assessed before and after partaking in either class in order to examine their gait, functional independence and spasticity. Participants will then be randomly assigned to either the 6-week neuropilates class or generalised exercise class. Participants will be 6 or more months post stroke and finished their formal rehabilitation. Participants should not be involved with any other rehabilitation therapies / hydrotherapy / gym services for the duration of the study. We will aim to recruit 30 participants to the study. The intervention group will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (a chartered physiotherapist who is also a pilates instructor). The control group will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility. Both exercise classes will take place in the Physiotherapy Department in St. John's Hospital, Sligo, Ireland

Conditions

Stroke

Study Design

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

Study Groups

Neuropilates class.

Will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (chartered physiotherapist and pilates instructor).

Pitched at a beginner level focused on the core elements of neuropilates and progressing week on week as appropriate.

Includes a warm up, cool down and neuropilates exercises in line with the teaching of APPI (the Australian Physiotherapy and Pilates Institute). Exercises may be completed on mats, chairs, gym balls, plinths and in standing, depending upon the ability level of the participant.

Two classes running with 8 participants in each based on their initial assessment into the higher and lower functionally independent participants.

Participants will be given a home exercise programme weekly based on exercises from the class and will be asked to complete these independently at home twice more during the week and to keep a training diary.

Group Type: EXPERIMENTAL

Home 'Neuropilates' exercise instructions.

Intervention Type: PROCEDURE

Participants will be given a home exercise programme weekly based on exercises from the neuropilates exercise class and will be asked to complete these independently at home twice more during the week and to keep a training diary.

Supervised Neuropilates Group Class

Intervention Type: PROCEDURE

Will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (a chartered physiotherapist who is also a pilates instructor).

Generalised exercise class.

Will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility.

Exercises will be more functional and generic than in the pilates classes and will be conducted in a circuit style, including mobility practice, sit to stand practice, cycling with the motomed, and general upper and lower limb strengthening. Warm up and cool downs will also be a feature of this class.

Participants will be also be given a home exercise programme based on exercises completed in the class and will be asked to complete these exercises twice more during the week and to keep a training diary.

Group Type: ACTIVE_COMPARATOR

Home 'General' exercise instructions.

Intervention Type: PROCEDURE

Participants will be given a home exercise programme weekly based on exercises from the general exercise class and will be asked to complete these independently at home twice more during the week and to keep a training diary.

Supervised General Exercises Group Class

Intervention Type: PROCEDURE

Will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility

Interventions

Home 'General' exercise instructions.

Participants will be given a home exercise programme weekly based on exercises from the general exercise class and will be asked to complete these independently at home twice more during the week and to keep a training diary.

Intervention Type: PROCEDURE

Home 'Neuropilates' exercise instructions.

Participants will be given a home exercise programme weekly based on exercises from the neuropilates exercise class and will be asked to complete these independently at home twice more during the week and to keep a training diary.

Intervention Type: PROCEDURE

Supervised Neuropilates Group Class

Will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (a chartered physiotherapist who is also a pilates instructor).

Intervention Type: PROCEDURE

Supervised General Exercises Group Class

Will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Aged > 18 years

2. Diagnosis of chronic stroke (>6 months post stroke event, as defined by Bernhardt et al, 2017) and formal rehabilitation completed.

3. Able to transfer (sit to stand and lateral transfers) independently with or without assistive device

4. Access to transport to enable attendance at one class per week

5. Cognitive ability to understand the programme.

Exclusion Criteria

1. Involvement in other studies or rehabilitation programmes.

2. Severe cognitive deficits or difficulty following instructions.

3. Significant hearing difficulties.

4. Significant visual deficit

5. Uncontrolled pain or uncontrolled high blood pressure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sligo General Hospital

OTHER

Sponsor Role: collaborator

Institute of Technology, Sligo

OTHER

Sponsor Role: collaborator

Dr. John Bartlett

OTHER

Sponsor Role: lead

Responsible Party

Dr. John Bartlett

Head of Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eimear Cronin, MSc Res

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Institute of Technology, Sligo

Sligo, Co Sligo, Ireland

Countries

Ireland

References

Cronin E, Monaghan K. Online neuropilates classes in chronic stroke patients: Protocol for a randomised controlled feasibility study. Contemp Clin Trials Commun. 2023 Jan 20;32:101068. doi: 10.1016/j.conctc.2023.101068. eCollection 2023 Apr.

Reference Type: DERIVED

PMID: 36747990 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ITSligo EC

Identifier Type: -

Identifier Source: org_study_id