Master track and field athletes’ perception of multimodal chiropractic care on sports performance, and its impact on muscular capacities

ISRCTN ISRCTN19833163
DOI https://doi.org/10.1186/ISRCTN19833163
EudraCT/CTIS number 2021-005437-17
IRAS number 303735
Secondary identifying numbers IRAS 303735
Submission date
19/01/2022
Registration date
20/01/2022
Last edited
30/10/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
Athletes want to optimise their performance and prevent injuries, and they typically explore many different strategies to give them a competitive advantage in sports events. Worldwide, manual therapies and chiropractic have been increasingly used in sports to help elite and masters athletes with pain management, return to sports and rehabilitation after an injury, injury prevention, enhancement of performance, and to recover faster after competitions. Pre-competition chiropractic care may be a way to identify and prevent a potential injury and to contribute to enhancing sports performance in masters athletes. Although there is vast research addressing the role of the best and common practices of chiropractic in older adults, none of them so far have included the ageing athletic population until now.
Therefore, the aim of this study is to explore and increase the understanding of aged 60+ years athletes' perceptions of the chiropractic encounter, the biomechanical and sports performance experiences, and its potential short-term functional impacts on plantar flexor muscle strength and accuracy sensory motor skills.

Who can participate?
Active track and field athletes aged 60 years and older from different clubs in the UK who compete at the national or/and international level from the disciplines of jumping, hurdling, sprinting, or distance running. Athletes with previous chiropractic care experience will be able to participate as the intervention group.

What does the study involve?
This study investigates whether there is any short-term functional impact on plantar flexor muscle maximum isometric strength and accuracy sensori-motor skill performances after one session of chiropractic care before competition. The chosen control will be a passive rest (times between PRE1-PRE2 and PRE2-PRE3) to minimise any sham-treatment effects. The study will be done at the track and field athletic venues or the chiropractic clinic at Friern Barnet or the biomechanical lab. The study design consists of two stations. One is for the outcome measures and the second for the intervention/control. Biomechanical testing of the muscles takes 20 minutes and is performed three times: the start/baseline (PRE1) the middle (PRE2) and after the intervention (POST) or rest control (PRE3). The entire procedure lasts 120 minutes.

What are the possible benefits and risks of participating?
It is expected that the evaluation and research process will contribute to our knowledge to offer guidelines to older master athletes and sports chiropractors. The study findings might be transferable to other master sports and manual therapy services working with an active ageing cohort.

Where is the study run from?
London South Bank University (UK)

When is the study starting and how long is it expected to run for?
July 2021 to June 2023

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Claudio Merkier
merkierc@lsbu.ac.uk
claudio.merkier@gmail.com

Study website

Contact information

Mr Claudio Merkier
Public

44 Glenthorne Road
London
N11 3Hj
United Kingdom

ORCiD logoORCID ID 0000-0003-0277-7190
Phone +44 (0)7787944910
Email claudio.merkier@gmail.com
Mr Claudio Merkier
Scientific

London South Bank University
103 Borough Road
London
SE1 0AA
United Kingdom

Phone +44 (0)7787944910
Email merkierc@lsbu.ac.uk

Study information

Study designMulticenter interventional pragmatic non-randomized feasibility trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Community
Study typeTreatment
Participant information sheet ISRCTN19833163_PIS.pdf
Scientific titleOlder MAster Track and Field AThletes PercEptions and Functional Impacts of PRe-Competition Chiropractic MAnual Therapies on Plantar FlexoR Muscle Strength, Accuracy Motor Skill and Sports PerformancE (MasterCare)
Study acronymMasterCare
Study hypothesisPre-competition chiropractic manual therapies improve maximum voluntary isometric contraction strength and accuracy motor coordination skill performances (slow and fast) more than rest control on plantar flexor muscles in healthy competing older masters track and field athletes.
Ethics approval(s)Approved 04/01/2022, Institute of Health and Social Care School of Ethics Panel at London South Bank University (Institute of Health and Social Care, London South Bank University, 103 Borough Road, London, SE1 0AA, UK; +44 (0)20 7815 7931; stewara2@lsbu.ac.uk), ref: ETH2021-0198
ConditionPre-competition sports performance
InterventionCurrent interventions as of 10/07/2023:

A 20-min session of chiropractic manual therapies (intervention) or 20 min of rest (control) prior to the participant's athletics competition event (not less than 24 hours).

This study is a non-randomised feasibility trial to investigate if there is any short-term functional impact on plantar flexor muscle strength and accuracy sensory-motor coordination performances after one session of chiropractic manual therapies prior to competition. The trial will be done at the track and field athletic venues or chiropractic clinics, within 24 hours prior to competing and during the 2022-23 seasons.

The trial protocol design consists of two stations. One is for the outcome measures and the second is for the intervention/control. The chosen intra-participant control will be a passive rest. Biomechanical testing includes maximum voluntary isometric contraction (MVIC) strength of plantar flexor muscles, slow (60 s) accuracy sensory-motor coordination performances of plantar flexor muscles (Slow delay: 60secs and fast delay: 15secs).
All the measurements of one round will take about 20 min. The biomechanical tests will be repeated three times: baseline (PRE1), middle (PRE2) and after (POST) intervention. The three biomechanical outcomes for the ankle plantar flexors are measured by a dynamometer and computer software (two custom-made strain gauge type dynamometers of 1,000 Hz, ankle and knee angle fixed at 90° to determine plantar-flexion moments and coordination for both legs
separately and a visual feedback system developed with LabVIEW-2013 SP1-National Instruments, Austin, TX). The entire procedure will last 120 min. The biomechanical section of the protocol (20 mins) has already been tested in older adults as reliable and valid outcomes (Epro et al. 2018). The performance outcome measures will be analysed using SPSS, including the 95% confidence interval (p<0.05) and 80% power sample size calculations.

_____

Previous interventions as of 03/04/2023:

A 20-min session of chiropractic manual therapies (intervention) or 20 min of rest (control) prior to the participant's athletics competition event (not less than 24 hours).

This study is a non-randomised feasibility trial to investigate if there is any short-term functional impact on plantar flexor muscle strength and accuracy motor skill performances after one session of chiropractic manual therapies prior to competition. The trial will be done at the track
and field athletic venues, within 24 hours prior to competing and during the 2022-23 seasons. The control group will be tested at Friern Barnet Chiro-Practice or at the biomechanical lab at London South Bank University.

The trial protocol design consists of two stations. One is for the outcome measures and the second for the intervention/control. The chosen control will be a passive rest to minimise any sham-treatment effects. Biomechanical testing includes maximum voluntary isometric contraction (MVIC) strength of plantar flexor muscles, slow (60 s) accuracy motor coordination skill performances (AMS-60) of plantar flexor muscles and fast (15 s) accuracy motor coordination skill performances (AMS-15) of plantar flexors muscles. All these measurements will take 20 min. The biomechanical tests will be measured three times: baseline (PRE1), middle (PRE2) and after (POST) intervention. The three biomechanical outcomes for the bilateral ankle plantar flexor moment are measured by a dynamometer and computer software (two custom-made strain gauge type dynamometers of 1,000 Hz, ankle and knee angle fixed at 90° to determine plantar-flexion moments for both legs separately and a visual feedback system developed with LabVIEW-2013 SP1-National Instruments, Austin, TX). The entire procedure will last 120 min. The biomechanical section of the protocol (20 mins) has been already tested in older adults as reliable and valid outcomes (Epro et al. 2018). The performance outcome measures will be analysed by using SPSS by including the 95% confidence interval (p<0.05) and 80% power sample size calculations.

_____

Previous interventions as of 06/03/2023:

A 20-min session of chiropractic manual therapies (intervention) or 20 min of rest (control) prior to the participant's athletics competition event (not less than 24 hours).

This study is a non-randomised feasibility trial to investigate if there is any short-term functional impact on plantar flexor muscle strength and accuracy motor skill performances after one session of chiropractic manual therapies prior to competition. The trial will be done at the track and field athletic venues, within 24 hours prior to competing and during the 2022 season.

The trial protocol design consists of two stations. One is for the outcome measures and the second for the intervention/control. The chosen control will be a passive rest to minimise any sham-treatment effects. Biomechanical testing includes maximum voluntary isometric contraction (MVIC) strength of plantar flexor muscles, slow (60 s) accuracy motor coordination skill performances (AMS-60) of plantar flexor muscles and fast (15 s) accuracy motor coordination skill performances (AMS-15) of plantar flexors muscles. All these measurements will take 20 min. The biomechanical tests will be measured three times: baseline (PRE1), middle (PRE2) and after (POST) intervention. The three biomechanical outcomes for the bilateral ankle plantar flexor moment are measured by a dynamometer and computer software (two custom-made strain gauge type dynamometers of 1,000 Hz, ankle and knee angle fixed at 90° to determine plantar-flexion moments for both legs separately and a visual feedback system developed with LabVIEW-2013 SP1-National Instruments, Austin, TX). The entire procedure will last 120 min. The biomechanical section of the protocol (20 mins) has been already tested in older adults as reliable and valid outcomes (Epro et al. 2018). The performance outcome measures will be analysed by using SPSS by including the 95% confidence interval (p<0.05) and 80% power sample size calculations.

_____

Previous interventions:

A 20-min session of chiropractic manual therapies (intervention) or 20 min of rest (control) within the 24 h prior to the participant's athletics competition event.

This study is a non-randomised feasibility trial to investigate if there is any short-term functional impact on plantar flexor muscle strength and accuracy motor skill performances after one session of chiropractic manual therapies prior to competition. The trial will be done at the track and field athletic venues, within 24 h prior to competing and during the 2022 season.

The trial protocol design consists of two stations. One is for the outcome measures and the second for the intervention/control. The chosen control will be a passive rest to minimise any sham-treatment effects. Biomechanical testing includes maximum voluntary isometric contraction (MVIC) strength of plantar flexor muscles, slow (60 s) accuracy motor coordination skill performances (AMS-60) of plantar flexor muscles and fast (15 s) accuracy motor coordination skill performances (AMS-15) of plantar flexors muscles. All these measurements will take 20 min. The biomechanical tests will be measured three times: baseline (PRE1), middle (PRE2) and after (POST) intervention. The three biomechanical outcomes for the bilateral ankle plantar flexor moment are measured by a dynamometer and computer software (two custom-made strain gauge type dynamometers of 1,000 Hz, ankle and knee angle fixed at 90° to determine plantar-flexion moments for both legs separately and a visual feedback system developed with LabVIEW-2013 SP1-National Instruments, Austin, TX). The entire procedure will last 120 min. The biomechanical section of the protocol (20 mins) has been already tested in older adults as reliable and valid outcomes (Epro et al. 2018). The performance outcome measures will be analysed by using SPSS by including the 95% confidence interval (p<0.05) and 80% power sample size calculations.
Intervention typeProcedure/Surgery
Primary outcome measureCurrent primary outcome measures as of 06/03/2023:
Measured by a dynamometer at baseline (PRE1), again after 20 min of rest (PRE2) and again after the chiropractic intervention (POST) or rest control (PRE3).
1. Maximum voluntary isometric contraction (MVIC) strength of the plantar flexor muscles
2. Slow accuracy motor skill (AMSS) performance of the plantar flexor muscles
3. Fast accuracy motor coordination skill (AMSF) performance of the plantar flexors muscles


Previous primary outcome measures from 20/05/2022 to 06/03/2023:
Measured by a dynamometer at baseline (PRE1), again after 20 min of rest (PRE2) and again after the chiropractic intervention (POST):
1. Maximum voluntary isometric contraction (MVIC) strength of the plantar flexor muscles
2. Slow accuracy motor skill (AMSS) performance of the plantar flexor muscles
3. Fast accuracy motor coordination skill (AMSF) performance of the plantar flexors muscles


Previous primary outcome measure:
Measured by a dynamometer at baseline (PRE1), again after 20 min of rest (PRE2) and again after the chiropractic intervention (POST):
1. Maximum voluntary isometric contraction (MVIC) strength of the plantar flexor muscles
2. Slow (60 s) accuracy motor skill (AMS-60) performance of the plantar flexor muscles
3. Fast (15 s) accuracy motor coordination skill (AMS-15) performance of the plantar flexors muscles
Secondary outcome measures1. Expected and perceived impact of MVIC measured using the global perceived effect (GPE) of change (7 points Likert scale) at POST intervention at 100 min from the baseline
2. Expected and perceived impact of AMS-60 measured using the global perceived effect (GPE) of change (7 points Likert scale) at POST intervention at 100 min from the baseline
3. Expected and perceived impact of AMS-15 measured using the global perceived effect (GPE) of change (7 points Likert scale) at POST intervention at 100 min from the baseline
Overall study start date18/07/2021
Overall study end date30/06/2023

Eligibility

Participant type(s)Healthy volunteer
Age groupSenior
SexBoth
Target number of participants15 (intervention group); 10 (control group)
Participant inclusion criteriaCurrent inclusion criteria as of 06/03/2023:
1. Active track and field athletes from different masters athletics clubs in the UK who have been competing at regional, national or/and international levels (Intervention group)
2. Aged 60 years and older (intervention and control groups)
3. The main athlete’s event is jumping, hurdling, sprinting, or distance running (intervention group)
4. The athlete has previous experience with chiropractic and manual therapies (intervention group)

Previous inclusion criteria:
1. Active track and field athletes from different masters athletics federation clubs in the UK who have been competing at regional, national or/and international levels
2. Aged 60 years and older
3. The main athlete’s event is jumping, hurdling, sprinting, or distance running
4. The athlete has previous experience with chiropractic and manual therapies
Participant exclusion criteriaCurrent exclusion criteria as of 06/03/2023:
1. Athletes or older adults aged 60+ with a history of any surgery or Achilles tendon's ruptures and/or problems (tendinopathies etc) within a 6-month period prior to trial
2. The main athlete’s event category is not jumping, hurdling, sprinting, or running (intervention group)
3. A score of 0, 1, or 2 in any item in the Lower Extremity Functional Scale (LEFS) (Binkley et al., 1999) during the recruitment process as a safety rule to minimise the risk of injury during the trial. A copy of the LEFS score will be sent to the potential participant by email or post in advance and completed at the beginning of the data collection research day

Previous exclusion criteria:
1. Athletes with a history of any surgery or Achilles tendon's ruptures and/or problems (tendinopathies etc) within a 6-month period prior to trial
2. The main athlete’s event category is not jumping, hurdling, sprinting, or running
3. A score of 0, 1, or 2 in any item in the Lower Extremity Functional Scale (LEFS) (Binkley et al., 1999) during the recruitment process as a safety rule to minimise the risk of injury during the trial. A copy of the LEFS score will be sent to the potential participant by email or post in advance and completed at the beginning of the data collection research day
Recruitment start date22/01/2022
Recruitment end date31/05/2023

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

London South Bank University
103 Borough Road
London
SE1 0AA
United Kingdom
Lee Valley Athletics Centre
Lee Valley Leisure Complex
61 Meridian Way
Edmonton
London
N9 0AR
United Kingdom
Derby Athletics Club
Moorways Stadium
Moor Lane
Allenton
Derby
DE24 9HY
United Kingdom
Horspath Athletics and Sports Ground
Horspath Rd
Oxford
OX4 2RR
United Kingdom
The Pingles Stadium
Avenue Road
Nuneaton
CV11 4LX
United Kingdom
Battersea Park Millennium Arena
East Carriage Drive
Battersea Park
London
SW11 4NJ
United Kingdom
Friern Barnet Chiro-Practice
44 Glenthorne Road
Friern Barnet
London
N11 3HJ
United Kingdom
London City Chiro-Practice
20 Aldermanbury
London
EC2V 7HY
United Kingdom

Sponsor information

London South Bank University
University/education

103 Borough Road
London
SE1 0AA
England
United Kingdom

Phone +44 (0)20 7815 7815
Email nicholt5@lsbu.ac.uk
Website http://www.lsbu.ac.uk/
ROR logo "ROR" https://ror.org/02vwnat91

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/10/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in non-publicly available repository, Not expected to be made available
Publication and dissemination planResults are planned to be published in a high impact peer-reviewed journal such as Chiropractic and Manual Therapies after completion of data analysis. The study protocol and statistical analysis plan will be available. The study has been registered at the open science framework website (https://osf.io/p9dha/).
IPD sharing planAll IPD will be stored in a non-publicly available repository and will be kept strictly confidential (subject to legal limitations). Data generated by the study will be retained in accordance with the University's Code of Practice. Digital recordings and records will be stored on an LSBU password protected server accessible only by the project team. Non-anonymised data (personal data) data will be stored for exactly as long as it is needed in compliance with the General Data Protection Regulations. All personal data will be kept for a period of 10 years after the completion of the project and then destroyed. In the write up of the study, all data will be completely anonymised. No names or any identifiable information will be included.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 23/06/2022 No Yes
Protocol file Feasibility trial procedure 23/06/2022 No No
Statistical Analysis Plan 27/03/2023 No No

Additional files

ISRCTN19833163_PIS.pdf
ISRCTN19833163_Protocol.pdf
Feasibility trial procedure
ISRCTN19833163 SAP.pdf

Editorial Notes

30/10/2024: The intention to publish date was changed from 01/10/2024 to 01/10/2025.
10/07/2023: The interventions were changed.
19/05/2023: The overall study end date has been changed from 31/05/2023 to 30/06/2023 and the plain English summary updated accordingly.
27/04/2023: The trial participating centre London City Chiro-Practice was added.
03/04/2023: The following changes were made to the trial record:
1. The overall end date was changed from 30/04/2023 to 31/05/2023.
2. The recruitment end date was changed from 30/04/2023 to 31/05/2023.
3. The interventions were changed.
4. The plain English summary was updated to reflect these changes.
27/03/2023: The statistical analysis plan was uploaded as an additional file.
06/03/2023: The following changes were made to the trial record:
1. The interventions, primary outcome measures, inclusion and exclusion criteria were updated.
2. The target number of participants was changed from 15 to 25.
27/02/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/04/2023 to 30/04/2023.
2. The intention to publish date was changed from 01/10/2023 to 01/10/2024.
07/02/2023: The overall end date was changed from 15/04/2023 to 30/04/2023.
01/11/2022: The trial participating centre Friern Barnet Chiro-Practice was added.
15/08/2022: The public title was changed from "Master track and field athletes' perceptions and impacts of multimodal chiropractic on muscular capacities and sports performance" to "Master track and field athletes’ perception of multimodal chiropractic care on sports performance, and its impact on muscular capacities".
12/08/2022: The public title was changed from "Master track and field athletes' perceptions and impacts of chiropractic on muscular capacities and sports performance" to "Master track and field athletes' perceptions and impacts of multimodal chiropractic on muscular capacities and sports performance".
09/08/2022: The public title was changed from "Master track and field athletes perceptions and impacts of chiropractic on calf muscle strength, accuracy, and sports performance" to "Master track and field athletes' perceptions and impacts of chiropractic on muscular capacities and sports performance".
04/07/2022: Trial website address updated.
23/06/2022: The following changes have been made:
1. The protocol (not peer reviewed) has been uploaded as an additional file.
2. The participant information sheet has been uploaded as an additional file.
08/06/2022: Battersea Park Millennium Arena was added as a trial participating centre.
20/05/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/10/2022 to 15/04/2023.
2. The overall trial end date has been changed from 15/11/2022 to 15/04/2023 and the plain English summary has been updated to reflect this change.
3. The primary outcome measure has been updated.
4. Internal review.
28/04/2022: "The Pingles Stadium" has been added as a trial participating centre.
08/04/2022: The following changes have been made:
1. The public title has been changed from "Masters track and field athletes perceptions and impacts of chiropractic on calf muscle strength, accuracy, and sports performance" to "Master track and field athletes perceptions and impacts of chiropractic on calf muscle strength, accuracy, and sports performance".
2. The scientific title has been changed from "Older MASterS Track and Field AThletes PercEptions and Functional Impacts of PRe-Competition Chiropractic MAnual Therapies on Plantar FlexoR Muscle Strength, Accuracy Motor Skill and Sports PerformancE (MasterCare)" to "Older MASter Track and Field AThletes PercEptions and Functional Impacts of PRe-Competition Chiropractic MAnual Therapies on Plantar FlexoR Muscle Strength, Accuracy Motor Skill and Sports PerformancE (MasterCare)".
3. The trial participating centre “Horspath Athletics and Sports Ground” have been added.
02/03/2022: The sponsor email was updated.
20/01/2022: Trial's existence confirmed by the Institute of Health and Social Care School of Ethics Panel at London South Bank University.