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Trial registered on ANZCTR


Registration number
ACTRN12620001085965
Ethics application status
Approved
Date submitted
16/03/2020
Date registered
20/10/2020
Date last updated
31/08/2023
Date data sharing statement initially provided
20/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact loading training in people with chronic obstructive pulmonary disease: a pilot study examining the feasibility and tolerance of this intervention and its effect on bone health
Scientific title
Impact loading training in people with chronic obstructive pulmonary disease: a pilot study examining the feasibility and tolerance of this intervention and its effect on bone health.
Secondary ID [1] 296927 0
Nil known
Universal Trial Number (UTN)
U1111-1225-8968
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 310965 0
Condition category
Condition code
Respiratory 309626 309626 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 316438 316438 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The total duration of the intervention period will be 40 weeks. For the first 8 weeks of the intervention period participants will complete a standard Pulmonary Rehabilitation Program (PRP). This program runs for an average of 8 weeks, with two 90-minute classes per week and includes all core components recommended by the international guidelines. These are aerobic and resistance exercise, psychosocial support, disease-specific education which includes information on self-management strategies. Each class is run by a physiotherapist in the hospital outpatient area and has up to 12 participants per class. As part of standard PRP all participants will be given a home exercise program (HEP) and exercise training log. As per standard practise the participants will be encouraged to complete the HEP 3 to 5 times a week whilst attending the PRP and they are encouraged to continue with the HEP after they have completed the PRP (as a life-long maintenance strategy). Exercises prescribed during the PRP (and HEP) are individualised for each participant but generally include a 20-30 minute walking program prescribed using the results of a 6-minute walk test together with functional lower limb exercises, such as steps ups and sit to stands and functional upper limb exercises using light hand weights (i.e. 500g-2kg) such as forward and upward punches. By completion of the PRP, patients are usually performing 3 sets of 10 repetitions of these functional exercises. In order to maximise musculoskeletal health and function, participants will be provided with calcium (1,000 mg/day) and vitamin D (800 IU/day) supplements, in oral tablet form, throughout the 40-week intervention period. Participants will be asked if they have previously taken or are currently taking calcium and Vitamin D supplements.

In addition to the usual PRP and HEP, participants will also undertake a program of targeted lower limb resistance exercises and impact loading exercises. The targeted lower limb resistance exercises will be completed in the PRP class (weeks 1-8) and will take between 10 and 20 minutes to complete. These exercises are specifically designed to improve gluteal, hamstring, quadriceps and calf muscle strength in preparation for the impact loading exercises. The exercises will include calf raises, knee flexion and extension using a multigym, seated knee flexion/extension with theraband if unable to use the multigym, squats and lunges. The target for each exercise is 1-3 sets for 8-10 repetitions (8-10 repetition maximum [RM] which is roughly equivalent to 75-80% of the 1RM). These exercises will be interspersed using a circuit based approach with the other exercises within the standard PRP session and will be closely supervised by a physiotherapist.

The impact loading exercises will commence in week 5 of the PRP. These will be individually prescribed for each participant using the current recommendations for exercise prescription for the prevention and management of osteoporosis. Using the Exercise and Sports Science Australia (ESSA) position statement (Beck et al, 2017), the intensity, frequency and sets/repetitions of each impact loading exercise will be tailored taking into account the participants existing bone health status, co-morbidities and functional/clinical risk factors for falls and fractures. Each participant will be categorised as low, moderate or high risk for a fragility fracture and the prescription of the impact loading exercises will be modified accordingly. All modifications to the exercise prescription detailed below will be recorded. Following weeks 1-4, the remainder of the intervention period is divided into Block 1 (Weeks 5-8), Block 2 (Weeks 9-16), Block 3 (Weeks 17-28) and Block 4 (Weeks 29-40). In Block 1 the participants will commence two impact loading exercises; bounding over hurdles and drop jumps. The target will be to complete 2 sets of 10 repetitions (1-2 minutes rest between each set). These will be completed during the PRP class under the supervision of a physiotherapist. In weeks 6 and 7 of Block 1, the participants who are tolerating the exercises, with no reports of pain or safety concerns, will be asked to complete an extra two sessions of the exercises unsupervised at home. The first home-based session will be supervised by a physiotherapist in the participant’s home. A suitable area will be established in the patient’s home environment to complete the exercises taking into account safety as well as a consistent floor surface. In addition to a consistent surface to complete the exercises at home, participants will be asked to wear the same or similar footwear every time they complete the exercises. The surface and footwear will be recorded. In Block 2 participants will continue with the impact loading exercises prescribed in Block 1 and will increase the number of target sets from 2 to 3. These will be completed four times per week at the participant’s home unsupervised.
At the beginning of Block 3 the participants will be visited by a physiotherapist at home and their impact loading exercises will be progressed to include an extra exercise; hopping on one leg. In Block 3 the three impact loading exercises will be completed with a target of completing 3 sets of 10 repetitions (1-2 minutes rest between sets) four times per week in the participants’ home unsupervised. At the beginning of Block 4 the participants will be visited by a physiotherapist who will again progress their exercises and add a new exercise; leaping. In Block 4 the four impact loading exercises will be completed unsupervised in the participants home, four times per week, with a target of achieving 3 sets of 10 repetitions (1-2 minutes rest in between each set).

If difficulties during impact loading training are reported, despite exercise modifications, the individual’s participation in the intervention will be discontinued. However, they will be asked to attend all remaining assessment sessions so their data can be analysed according to the intention-to-treat principle. Participants will be regularly asked if they are experiencing any issues with stress continence during the impact loading exercises and offered a referral to a continence physiotherapist clinic if this is reported.

Measures related to the primary aim (i.e. feasibility and tolerance) will be recorded throughout the duration of the study using exercise logs and scheduled contact points with the participants. The exercise prescription and any modifications to the exercises will be recorded in these logs. From Block 2, participants will receive fortnightly phone calls from the primary investigator. To assess feasibility of the study protocol, data will be recorded pertaining to recruitment, withdrawal and completion, as well as adherence to the prescribed sessions (using an exercise log, completed by the participant). Participants will also be asked about their adherence to taking the calcium and Vitamin D supplements.
Tolerance of the intervention will be assessed and monitored by;
1. Asking participants to rate symptoms of lower limb joint discomfort / pain, breathlessness and perceived exertion, at the completion of each exercise session, using validated scales (i.e. BORG dyspnoea and the visual analogue scale [VAS]).
2. Asking participants to immediately contact the primary investigator if they experience any adverse events, such as a fall, throughout the duration of the study. These data will be recorded by the primary investigator. These will be classified as minor (self-resolving) or major (required medical intervention).
3. On study completion, seeking feedback from participants regarding their experiences.
Intervention code [1] 313269 0
Treatment: Other
Intervention code [2] 313270 0
Rehabilitation
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318582 0
Feasibility
Feasibility of the study protocol will be collected as data recorded pertaining to recruitment, withdrawal and completion, as well as adherence to the intervention (targeted lower limb exercises and impact loading exercises) using an exercise log completed by the participant. In addition during both the PRP and home home-based exercises, adherence will be tracked using an exercise log, completed by the participant.
Timepoint [1] 318582 0
Feasibility will be collected throughout the duration of the 40 week intervention.
Primary outcome [2] 318583 0
Tolerance of the intervention will be assessed and monitored by; 1. Asking participants to rate symptoms of lower limb joint discomfort / pain, breathlessness and perceived exertion, at the completion of each exercise session, using validated scales (i.e. BORG dyspnoea and the visual analogue scale [VAS]). 2. Asking participants to immediately contact the primary investigator if they experience any adverse events, such as a fall, throughout the duration of the study. These data will be recorded by the primary investigator. They will be classified as minor (self-resolving) or major (requiring medical intervention). 3. On study completion, feedback (through semi-structured interviews completed by the PhD candidate) will be sought from participants regarding their experiences.
Timepoint [2] 318583 0
This will be collected at each session the exercises are completed using the exercise logs. In addition it will be collected throughout the duration of the study when participants contact the primary investigator ad hoc or during the fortnightly phone calls. It will also be collected after the end of the 40-week intervention period.
Secondary outcome [1] 365436 0
Bone health
Dual-energy X-ray absorptiometry (DXA, Lunar Prodigy) will be used to assess bone mineral density (BMD) (g/cm2) of the hip (total hip and femoral neck) and lumbar spine (L2 to L4) regions as well as whole body bone mineral content (BMC, g)
Timepoint [1] 365436 0
Measured pre-randomisation and following the completion of the 40-week intervention period.
Secondary outcome [2] 365437 0
Balance using the Berg Balance Scale (BBS), Activities-specific Balance Confidence (ABC) and Four Square Step Test (FSST)
Timepoint [2] 365437 0
Measured pre-randomisation, the end of the 8-week PRP and at the end of 40-week intervention period.
Secondary outcome [3] 365438 0
Falls risk using the Falls Risk for Older People in the Community Screen (FROP-Com Screen)
Timepoint [3] 365438 0
Measured pre-randomisation, the end of the 8-week PRP and at the end of 40-week intervention period.
Secondary outcome [4] 365439 0
Exercise capacity using the six-minute walk test (6MWT)
Timepoint [4] 365439 0
Measured pre-randomisation, the end of the 8-week PRP and at the end of 40-week intervention period.
Secondary outcome [5] 365440 0
Health related quality of life measured using the interviewer administered version of the Chronic Respiratory Disease Questionnaire (CRDQ)
Timepoint [5] 365440 0
Measured pre-randomisation, the end of the 8-week PRP and at the end of 40-week intervention period.
Secondary outcome [6] 365441 0
The modified Medical Research Council Scale (mMRC) will be used to measure functional limitation resulting from dyspnoea.
Timepoint [6] 365441 0
Measured pre-randomisation, the end of the 8-week PRP and at the end of 40-week intervention period.
Secondary outcome [7] 365442 0
Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS)
Timepoint [7] 365442 0
Measured pre-randomisation, the end of the 8-week PRP and at the end of 40-week intervention period.
Secondary outcome [8] 386170 0
Body Composition
Regional and whole body lean mass (including appendicular skeletal muscle mass) and fat mass will be derived from a whole body dual-energy X-ray absorptiometry (DXA, Lunar Prodigy) scan.
Timepoint [8] 386170 0
Measured pre-randomisation and following the completion of the 40-week intervention period.

Eligibility
Key inclusion criteria
People who have confirmed diagnosis of COPD according to the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and are referred to the PRP at St John of God Midland Public and Private Hospitals.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) take prescription medication known to affect bone metabolism; (ii) have any significant injury or surgical intervention that impairs their capacity to participate in weight bearing activity; (iii) have any past or present evidence of a fragility fracture; (iv) have any co-morbid condition thought to significantly compromise performance during the assessments and intervention; (v) are unable to understand spoken or written English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Intention to treat analysis will be used.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analyses will be performed using SPSS® (Statistical Package for Social Sciences, version 25.0 for Windows). As this is a pilot study, data pertaining to the primary aims (i.e. feasibility / tolerance) will be reported using descriptive statistics such as means and standard deviations (parametric data) or medians and interquartile ranges (non-parametric or ordinal data). Categorical data will be reported as frequencies and proportions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/10/2020
Actual
6/11/2020
Date of last participant enrolment
Anticipated
1/09/2023
Actual
Date of last data collection
Anticipated
10/06/2024
Actual
Sample size
Target
25
Accrual to date
23
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 12860 0
St John of God Midland Public Hospital - Midland
Recruitment postcode(s) [1] 25336 0
6056 - Midland

Funding & Sponsors
Funding source category [1] 301500 0
Charities/Societies/Foundations
Name [1] 301500 0
Osteoporosis Australia
Country [1] 301500 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Perth
Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 301194 0
Hospital
Name [1] 301194 0
St John of God Midland Public and Private Hosptials
Address [1] 301194 0
1 Clayton Street, Midland, Perth
Western Australia, 6056
Country [1] 301194 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302242 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 302242 0
Ethics committee country [1] 302242 0
Australia
Date submitted for ethics approval [1] 302242 0
07/01/2019
Approval date [1] 302242 0
15/03/2019
Ethics approval number [1] 302242 0
#1494
Ethics committee name [2] 305608 0
Curtin University Human Research Ethics Office
Ethics committee address [2] 305608 0
Ethics committee country [2] 305608 0
Australia
Date submitted for ethics approval [2] 305608 0
03/02/2020
Approval date [2] 305608 0
06/02/2020
Ethics approval number [2] 305608 0
HRE2020-0044

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89558 0
Ms Erin Cecins
Address 89558 0
Allied Health (Physiotherapy)
St John of God Midland Public and Private Hospitals
1 Clayton Street, Midland
WA, 6056
Country 89558 0
Australia
Phone 89558 0
+618 94624326
Fax 89558 0
Email 89558 0
Erin.Cecins@sjog.org.au
Contact person for public queries
Name 89559 0
Erin Cecins
Address 89559 0
Allied Health (Physiotherapy)
St John of God Midland Public and Private Hospitals
1 Clayton Street, Midland
WA, 6056
Country 89559 0
Australia
Phone 89559 0
+61 8 94624326
Fax 89559 0
Email 89559 0
Erin.Cecins@sjog.org.au
Contact person for scientific queries
Name 89560 0
Erin Cecins
Address 89560 0
Allied Health (Physiotherapy)
St John of God Midland Public and Private Hospitals
1 Clayton Street, Midland
WA, 6056
Country 89560 0
Australia
Phone 89560 0
+618 94624326
Fax 89560 0
Email 89560 0
Erin.Cecins@sjog.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFeasibility, tolerance and effects of adding impact loading exercise to pulmonary rehabilitation in people with chronic obstructive pulmonary disease: study protocol for a pilot randomised controlled trial.2021https://dx.doi.org/10.1186/s40814-021-00893-1
N.B. These documents automatically identified may not have been verified by the study sponsor.