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The ADAPTation to Therapeutic Resistance Training (ADAPT) Study

Primary Purpose

Musculoskeletal Injury, Muscle Weakness

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Resistance Training
Sponsored by
Defence Medical Rehabilitation Centre, UK
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Injury focused on measuring Musculoskeletal rehabilitation, Blood flow restriction, Resistance training, knee pain, military

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: mechanical knee pain for at least three months present with clinical signs and symptoms of knee pain arising from the tibiofemoral or patellofemoral joint diagnosed by sport and exercise medicine physician and/or physiotherapist have reduced occupational employability medical grade secondary to their knee pain report progression of resistance training load within the patient's rehabilitation programme is limited by knee pain aged between 18 and 55 years available to attend for the entire duration of the RRU course and a review appointment 3-months following course. Exclusion Criteria: diagnosed tibial, femoral or patella fracture and/or dislocation; present with instability in the knee resulting from ligament deficiency present with clinical signs and symptoms of patellar tendinopathy have planned surgery over the study period restricted knee range of movement; clinical signs and symptoms of non-musculoskeletal or serious pathological condition (i.e. Inflammatory arthropathy, infection or tumour) or referred pain from non-local pain source present with any physical impairment or co-morbidities (including cardio-vascular disease) precluding the safe participation in the rehabilitation programme and/or assessment procedures Cortico-steroid or analgesic injection intervention within the previous 7-days or previous knee surgery within the last 12 months to the affected limb Medical Exclusion Criteria: History of cardiovascular disease including hypertension, peripheral vascular disease, thrombosis/embolism, ischaemic heart disease, myocardial infarction. History of the following musculoskeletal disorders: rheumatoid arthritis, avascular necrosis or osteonecrosis, severe osteoarthritis. History of the following neurological disorders: Peripheral neuropathy, Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, severe traumatic brain injury. Varicose veins in the lower limb Acute viral or bacterial upper or lower respiratory infection at screening Known or suspected lower limb chronic exertional compartment syndrome (CECS) Postsurgical swelling Surgical insertion of metal components at the position of cuff inflation History of any of the following conditions or disorders not previously listed: diabetes, active cancer History of elevated risk of unexplained fainting or dizzy spells during physical activity/exercise that causes loss of balance History of haemorrhagic stroke or exercise induced rhabdomyolysis

Sites / Locations

  • RRU AldershotRecruiting
  • RRU ColchesterRecruiting
  • RRU CranwellRecruiting
  • RRU EdinburghRecruiting
  • RRU St AthanRecruiting
  • RRU BulfordRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low-load blood flow restriction training (LL-BFR)

Heavier load resistance training (HL-RT)

Arm Description

Twice daily LL-BFR for 3 weeks

Three sessions per week for 3 weeks

Outcomes

Primary Outcome Measures

Change in Lower Extremity Functional Scale (LEFS) over time
LEFS is a 20-question patient-reported outcome measure (PROM) that measures functional status in patients with lower limb musculoskeletal injury. Questions on activity vary in physical demand from walking to running on uneven ground. The LEFS is a validated tool and has demonstrated good test-retest reliability and responsiveness in individuals with persistent knee pain.

Secondary Outcome Measures

Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) over time
Change in Patient Specific Functional Scale over time
Change in Musculoskeletal Health Questionnaire (MSK-HQ) over time
Change in Tampa Scale of Kinesiophobia (TSK) over time
Health Anxiety Depression Scale (HADS)
Change in International Physical Activity Questionnaire (IPAQ) over time
Change in Numeric Pain Rating Scale (NPRS) over time
Change in Sport Injury Rehabilitation Beliefs Survey (SIRBS) over time
Change in functional Activity Assessment (FAA) over time
Change in five Repetition Maximum Leg Press over time
Change in isometric muscle strength of hip and knee using hand-held dynamometer over time
Change in single leg heel raises to fatigue over time
Change in qualitative assessment of single leg squat (QASLS) over time
Change in decline knee bend over time
Change in isometric midthigh pull over time
Change in counter-movement jump over time
Change in knee extension and flexion - maximal isometric voluntary contraction over time
Change in muscle volume and anatomical cross sectional area (CSA) using magnetic resonance imaging (MRI) over time
Change in pennation angle over time using ultrasonography
Pennation angle measured in degrees
Change in fascicle length over time using ultrasonography
fascicle length measured in mm
Change in single leg squat over time - kinetic and kinematic analysis
3D motion capture and force plate data will be used to collect kinetic and kinematic data which will be later analysed using inverse dynamics. Force measured in Newtons, Moments measured in Newton/Metres/kg
Change in bilateral squat over time - kinetic and kinematic analysis
3D motion capture and force plate data will be used to collect kinetic and kinematic data which will be later analysed using inverse dynamics. Force measured in Newtons, Moments measured in Newton/Metres/kg
Change in markers of muscle damage over time
Using fasted blood samples. E.g., Creatine Kinase (units/L)
Change in markers of oxidative stress over time
Using fasted blood samples. E.g., Protein carbonyl (units/L)
Change in markers of inflammation over time
Using fasted blood samples. E.g., Interleukin-6 (pg/ml)
Change in markers of endothelial function over time
Using fasted blood samples. E.g., Vascular endothelial growth factor (µg/L)
Change in daily monitoring of wellness score over time
Subjective patient reported outcome measure of 'wellness' scored using a 5-point likert scale.
Change in daily monitoring of session rate of perceived exertion (sRPE) over time
Subjective patient reported outcome measure of exertion, scored 0 to 10 (0 = no exertion, 10= maximal exertion)
Change in daily monitoring of pain over time
Subjective patient reported outcome measure of pain measured using a 0 to 100mm visual analog scale (VAS). 0= no pain, 100 = worst pain

Full Information

First Posted
January 19, 2023
Last Updated
January 30, 2023
Sponsor
Defence Medical Rehabilitation Centre, UK
Collaborators
University of Bath
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1. Study Identification

Unique Protocol Identification Number
NCT05719922
Brief Title
The ADAPTation to Therapeutic Resistance Training (ADAPT) Study
Official Title
Low-load Blood Flow Restriction Exercise Versus Conventional Heavier Load Resistance Training Exercise in UK Military Personnel With Persistent Knee Pain: A Multi-centre Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Defence Medical Rehabilitation Centre, UK
Collaborators
University of Bath

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
In 2018, the Academic Department of Military Rehabilitation (ADMR) published a pilot randomised controlled trial (RCT), demonstrating the feasibility and acceptability of integrating twice-daily blood flow restriction (BFR) training into a busy residential care setting. Following its publication was a guidance note written by the Directorate of Defence Rehabilitation restricting the implementation of BFR training until more evidence can be provided to support its efficacy. This research trial is a fully-powered, multi-centre RCT investigating the efficacy and biological mechanism underpinning BFR therapy in UK military personnel with lower-limb musculoskeletal injury (specifically, persistent anterior knee pain) during residential rehabilitation. This study will aim to optimise both the rehabilitation outcome and improve the time-and cost-effectiveness of the service delivered across UK Defence Rehabilitation and beyond. Results will provide insight and knowledge to the clinical and scientific community to not only those embedded within Defence Rehabilitation, but also those working in civilian sector organisations and professional sport in the UK and abroad.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Injury, Muscle Weakness
Keywords
Musculoskeletal rehabilitation, Blood flow restriction, Resistance training, knee pain, military

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-load blood flow restriction training (LL-BFR)
Arm Type
Experimental
Arm Description
Twice daily LL-BFR for 3 weeks
Arm Title
Heavier load resistance training (HL-RT)
Arm Type
Active Comparator
Arm Description
Three sessions per week for 3 weeks
Intervention Type
Other
Intervention Name(s)
Resistance Training
Intervention Description
Comparing two different exercise-based treatment methodologies on the clinical outcomes of individuals with persistent knee pain.
Primary Outcome Measure Information:
Title
Change in Lower Extremity Functional Scale (LEFS) over time
Description
LEFS is a 20-question patient-reported outcome measure (PROM) that measures functional status in patients with lower limb musculoskeletal injury. Questions on activity vary in physical demand from walking to running on uneven ground. The LEFS is a validated tool and has demonstrated good test-retest reliability and responsiveness in individuals with persistent knee pain.
Time Frame
Baseline, week 3 and week 15
Secondary Outcome Measure Information:
Title
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) over time
Time Frame
Baseline, week 3 and week 15
Title
Change in Patient Specific Functional Scale over time
Time Frame
Baseline, week 3 and week 15
Title
Change in Musculoskeletal Health Questionnaire (MSK-HQ) over time
Time Frame
Baseline, week 3 and week 15
Title
Change in Tampa Scale of Kinesiophobia (TSK) over time
Time Frame
Baseline, week 3 and week 15
Title
Health Anxiety Depression Scale (HADS)
Time Frame
Baseline
Title
Change in International Physical Activity Questionnaire (IPAQ) over time
Time Frame
Baseline, week 3 and week 15
Title
Change in Numeric Pain Rating Scale (NPRS) over time
Time Frame
Baseline, week 3 and week 15
Title
Change in Sport Injury Rehabilitation Beliefs Survey (SIRBS) over time
Time Frame
Baseline, week 3 and week 15
Title
Change in functional Activity Assessment (FAA) over time
Time Frame
Baseline and week 15
Title
Change in five Repetition Maximum Leg Press over time
Time Frame
Baseline, week 3 and week 15
Title
Change in isometric muscle strength of hip and knee using hand-held dynamometer over time
Time Frame
Baseline, week 3 and week 15
Title
Change in single leg heel raises to fatigue over time
Time Frame
Baseline, week 3 and week 15
Title
Change in qualitative assessment of single leg squat (QASLS) over time
Time Frame
Baseline, week 3 and week 15
Title
Change in decline knee bend over time
Time Frame
Baseline, week 3 and week 15
Title
Change in isometric midthigh pull over time
Time Frame
Baseline, week 3 and week 15
Title
Change in counter-movement jump over time
Time Frame
Baseline, week 3 and week 15
Title
Change in knee extension and flexion - maximal isometric voluntary contraction over time
Time Frame
Baseline, week 3 and week 15
Title
Change in muscle volume and anatomical cross sectional area (CSA) using magnetic resonance imaging (MRI) over time
Time Frame
Baseline, week 3 and week 15
Title
Change in pennation angle over time using ultrasonography
Description
Pennation angle measured in degrees
Time Frame
Baseline, week 3 and week 15
Title
Change in fascicle length over time using ultrasonography
Description
fascicle length measured in mm
Time Frame
Baseline, week 3 and week 15
Title
Change in single leg squat over time - kinetic and kinematic analysis
Description
3D motion capture and force plate data will be used to collect kinetic and kinematic data which will be later analysed using inverse dynamics. Force measured in Newtons, Moments measured in Newton/Metres/kg
Time Frame
Baseline, week 3 and week 15
Title
Change in bilateral squat over time - kinetic and kinematic analysis
Description
3D motion capture and force plate data will be used to collect kinetic and kinematic data which will be later analysed using inverse dynamics. Force measured in Newtons, Moments measured in Newton/Metres/kg
Time Frame
Baseline, week 3 and week 15
Title
Change in markers of muscle damage over time
Description
Using fasted blood samples. E.g., Creatine Kinase (units/L)
Time Frame
Baseline, week 3 and week 15
Title
Change in markers of oxidative stress over time
Description
Using fasted blood samples. E.g., Protein carbonyl (units/L)
Time Frame
Baseline, week 3 and week 15
Title
Change in markers of inflammation over time
Description
Using fasted blood samples. E.g., Interleukin-6 (pg/ml)
Time Frame
Baseline, week 3 and week 15
Title
Change in markers of endothelial function over time
Description
Using fasted blood samples. E.g., Vascular endothelial growth factor (µg/L)
Time Frame
Baseline, week 3 and week 15
Title
Change in daily monitoring of wellness score over time
Description
Subjective patient reported outcome measure of 'wellness' scored using a 5-point likert scale.
Time Frame
Daily for the 3 weeks of rehabilitation
Title
Change in daily monitoring of session rate of perceived exertion (sRPE) over time
Description
Subjective patient reported outcome measure of exertion, scored 0 to 10 (0 = no exertion, 10= maximal exertion)
Time Frame
Daily for the 3 weeks of rehabilitation
Title
Change in daily monitoring of pain over time
Description
Subjective patient reported outcome measure of pain measured using a 0 to 100mm visual analog scale (VAS). 0= no pain, 100 = worst pain
Time Frame
Daily for the 3 weeks of rehabilitation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: mechanical knee pain for at least three months present with clinical signs and symptoms of knee pain arising from the tibiofemoral or patellofemoral joint diagnosed by sport and exercise medicine physician and/or physiotherapist have reduced occupational employability medical grade secondary to their knee pain report progression of resistance training load within the patient's rehabilitation programme is limited by knee pain aged between 18 and 55 years available to attend for the entire duration of the RRU course and a review appointment 3-months following course. Exclusion Criteria: diagnosed tibial, femoral or patella fracture and/or dislocation; present with instability in the knee resulting from ligament deficiency present with clinical signs and symptoms of patellar tendinopathy have planned surgery over the study period restricted knee range of movement; clinical signs and symptoms of non-musculoskeletal or serious pathological condition (i.e. Inflammatory arthropathy, infection or tumour) or referred pain from non-local pain source present with any physical impairment or co-morbidities (including cardio-vascular disease) precluding the safe participation in the rehabilitation programme and/or assessment procedures Cortico-steroid or analgesic injection intervention within the previous 7-days or previous knee surgery within the last 12 months to the affected limb Medical Exclusion Criteria: History of cardiovascular disease including hypertension, peripheral vascular disease, thrombosis/embolism, ischaemic heart disease, myocardial infarction. History of the following musculoskeletal disorders: rheumatoid arthritis, avascular necrosis or osteonecrosis, severe osteoarthritis. History of the following neurological disorders: Peripheral neuropathy, Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, severe traumatic brain injury. Varicose veins in the lower limb Acute viral or bacterial upper or lower respiratory infection at screening Known or suspected lower limb chronic exertional compartment syndrome (CECS) Postsurgical swelling Surgical insertion of metal components at the position of cuff inflation History of any of the following conditions or disorders not previously listed: diabetes, active cancer History of elevated risk of unexplained fainting or dizzy spells during physical activity/exercise that causes loss of balance History of haemorrhagic stroke or exercise induced rhabdomyolysis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Ladlow, PhD
Phone
+44 (0)1509251500
Ext
3403
Email
peter.ladlow100@mod.gov.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Russ Coppack, PhD
Phone
+44(0)1509251500
Ext
4418
Email
Russ.Coppack100@mod.gov.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Bennett, PhD
Organizational Affiliation
Defence Medical Rehabilitation Centre
Official's Role
Study Chair
Facility Information:
Facility Name
RRU Aldershot
City
Aldershot
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ollie Rosenstock
Facility Name
RRU Colchester
City
Colchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Spanner
Facility Name
RRU Cranwell
City
Cranwell
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
RRU Edinburgh
City
Edinburgh
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gordon McKay
Facility Name
RRU St Athan
City
St Athan
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
RRU Bulford
City
Tidworth
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Essam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised participant data will be made available upon reasonable request to the chief investigator.
IPD Sharing Time Frame
Upon completion of the dissemination of research findings (i.e, publications and conference proceedings)
IPD Sharing Access Criteria
Most data will be openly available but, due to privacy concerns, some data regarding participants are available only to bona fide researchers working on a related project, subject to the completion of a non-disclosure agreement.

Learn more about this trial

The ADAPTation to Therapeutic Resistance Training (ADAPT) Study

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