AdherenceNCT02822755
Home Exercise Adherence in Physical Therapy
A study testing Home Exercise Program and Adherence Logs in people with Adherence, run by Evan J. Petersen at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of an individualized video recording in improving adherence in home exercise programs for orthopaedic physical therapy patients. Specific aims: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adherence
- What is being tested?
- Home Exercise Program and Adherence Logs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who can read and understand the English language,
- adults between 18-65 years of age,
- have a referral to an outpatient physical therapy clinic for an orthopaedic condition, and
- who own a smartphone with video recording capabilities and available data storage space (at least 500 MB or 0.5 GB).
Who cannot join
- Individuals referred for non-orthopaedic conditions,
- individuals currently on an established, prescribed home exercise program,
- individuals requiring more than 4 home exercises at one time as part of their rehabilitation program, and
- individuals who do not own a smartphone device with the required storage and recording specifications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Physical Therapy Specialists
San Antonio, Texas, 78209
About this study
Official title: Effectiveness of Individualized Video Recordings Versus Conventional Printed Instructions on Home Exercise Program Adherence in Physical Therapy
The purpose of this study is to determine the effectiveness of an individualized video recording in improving adherence in home exercise programs for orthopaedic physical therapy patients.
Specific aims:
- Evaluate whether individualized video recordings improve adherence with home exercise programs (HEP) as compared with conventional printed instructions measured by a self-report exercise log. (1-tail analysis)
Read the detailed description
This investigation will focus on the specific issues surrounding adherence to the use of individualized video recordings via smartphone versus conventional printed instructions in patients with orthopaedic injuries. The data reported will be used to explore the feasibility and potential benefits of smartphone usage for home exercise adherence.
- Conditions
- Adherence
- Being tested
- Home Exercise Program and Adherence Logs
- Keywords
- Exercise, Adherence, Physical Therapy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Exercise Program and Adherence LogsOther
Also called HEP
Both groups will receive physical therapy prescribed home exercises and be asked to record adherence to their program on an exercise log.
| Study group | Role | What they receive |
|---|---|---|
| Video Recording Group | Experimental | The experimental group participants will be recorded on their personal smartphone performing their prescribed exercises with individualized instruction from the participating physical therapist. The prescribing therapist will record participants on their own smartphones doing the exercise program in the clinic so that participants can have that video recording of the exercises to help remind them how to do the exercises properly at home. Participants will not be asked to record themselves performing future exercise sessions as documentation of improvement. Intervention: Home Exercise Program and Adherence Logs Receives: Other: Home Exercise Program and Adherence Logs |
| Conventional Printed Group | Active comparator | The active comparator group will receive individualized instruction from the participating physical therapist on how to perform their home exercise program as well as printed instructions of the exercises. No video recording of the control group participants will be performed. Intervention: Home Exercise Program and Adherence Logs Receives: Other: Home Exercise Program and Adherence Logs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Home Exercise Adherence
Data will be recorded via a self-reported exercise log that includes number of days exercises were completed per week. Participants will record the number of days participants did "All" of the program (defined as doing 100% of their exercises), "Most" of the program (defined as doing 75% of their exercises), "Some" of the program (defined as doing 50% of their program, and "None" of the program (defined as doing 0% of their exercise program).
Measured: Weekly for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2018
- Study completionSep 2018
Why it stopped: Data collection sites lost research personnel that were recruiting subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evan J. Petersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Evan J. Petersen, University of the Incarnate Word
- Investigators
- Evan J Petersen, PT, DSc, Study chair, University of the Incarnate Word
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822755
- Sponsor's protocol ID
- UniversityIW
- Status last verified
- Apr 2019
- First submitted
- 30 Jun 2016
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: All individual data will be reported as a group
Publications
Gonzalez JS, McCarl LA, Wexler D DD, Cagliero E, Delahanty L, Soper TD, Goldman V, Knauz R, Safren SA. Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in Type 2 Diabetes. J Cogn Psychother. 2010 Nov 1;24(4):329-343. doi: 10.1891/0889-8391.24.4.329.
PubMed 23667294Hammer C, Degerfeldt L, Denison E. Mechanical diagnosis and therapy in back pain: Compliance and social cognitive theory. Adv Physiother. 2007;9(4):190-197.
Marks R, Allegrante JP. Chronic osteoarthritis and adherence to exercise: a review of the literature. J Aging Phys Act. 2005 Oct;13(4):434-60. doi: 10.1123/japa.13.4.434.
PubMed 16301755Papaioannou A, Kennedy CC, Dolovich L, Lau E, Adachi JD. Patient adherence to osteoporosis medications: problems, consequences and management strategies. Drugs Aging. 2007;24(1):37-55. doi: 10.2165/00002512-200724010-00003.
PubMed 17233546Conraads VM, Deaton C, Piotrowicz E, Santaularia N, Tierney S, Piepoli MF, Pieske B, Schmid JP, Dickstein K, Ponikowski PP, Jaarsma T. Adherence of heart failure patients to exercise: barriers and possible solutions: a position statement of the Study Group on Exercise Training in Heart Failure of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2012 May;14(5):451-8. doi: 10.1093/eurjhf/hfs048. Epub 2012 Apr 11.
PubMed 22499542Jordan JL, Holden MA, Mason EE, Foster NE. Interventions to improve adherence to exercise for chronic musculoskeletal pain in adults. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD005956. doi: 10.1002/14651858.CD005956.pub2.
PubMed 20091582Yuen HK, Wang E, Holthaus K, Vogtle LK, Sword D, Breland HL, Kamen DL. Self-reported versus objectively assessed exercise adherence. Am J Occup Ther. 2013 Jul-Aug;67(4):484-9. doi: 10.5014/ajot.2013.007575.
PubMed 23791324Holden MA, Haywood KL, Potia TA, Gee M, McLean S. Recommendations for exercise adherence measures in musculoskeletal settings: a systematic review and consensus meeting (protocol). Syst Rev. 2014 Feb 10;3:10. doi: 10.1186/2046-4053-3-10.
PubMed 24512976Kramer A, Dettmers C, Gruber M. Exergaming with additional postural demands improves balance and gait in patients with multiple sclerosis as much as conventional balance training and leads to high adherence to home-based balance training. Arch Phys Med Rehabil. 2014 Oct;95(10):1803-9. doi: 10.1016/j.apmr.2014.04.020. Epub 2014 May 10.
PubMed 24823959Friedrich M, Cermak T, Maderbacher P. The effect of brochure use versus therapist teaching on patients performing therapeutic exercise and on changes in impairment status. Phys Ther. 1996 Oct;76(10):1082-8. doi: 10.1093/ptj/76.10.1082.
PubMed 8863761Harkapaa K, Jarvikoski A, Mellin G, Hurri H. A controlled study on the outcome of inpatient and outpatient treatment of low back pain. Part I. Pain, disability, compliance, and reported treatment benefits three months after treatment. Scand J Rehabil Med. 1989;21(2):81-9.
PubMed 2526364Khalil H, Quinn L, van Deursen R, Martin R, Rosser A, Busse M. Adherence to use of a home-based exercise DVD in people with Huntington disease: participants' perspectives. Phys Ther. 2012 Jan;92(1):69-82. doi: 10.2522/ptj.20100438. Epub 2011 Sep 29.
PubMed 21960468Roddey TS, Olson SL, Gartsman GM, Hanten WP, Cook KF. A randomized controlled trial comparing 2 instructional approaches to home exercise instruction following arthroscopic full-thickness rotator cuff repair surgery. J Orthop Sports Phys Ther. 2002 Nov;32(11):548-59. doi: 10.2519/jospt.2002.32.11.548.
PubMed 12449254
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Individualized Video Recordings Versus Conventional Printed Instructions on Home Exercise Program Adherence in Physical Therapy
- ClinicalTrials.gov ID
- NCT02822755
- Acronym / sponsor ID
- UniversityIW
- Conditions
- Adherence
- Keywords
- Exercise, Adherence, Physical Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data collection sites lost research personnel that were recruiting subjects.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Evan J. PetersenUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of an individualized video recording in improving adherence in home exercise programs for orthopaedic physical therapy patients.
Specific aims:
- Evaluate whether individualized video recordings improve adherence with home exercise programs (HEP) as compared with conventional printed instructions measured by a self-report exercise log. (1-tail analysis)
Detailed description
This investigation will focus on the specific issues surrounding adherence to the use of individualized video recordings via smartphone versus conventional printed instructions in patients with orthopaedic injuries. The data reported will be used to explore the feasibility and potential benefits of smartphone usage for home exercise adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Recording Group | Experimental | Other: Home Exercise Program and Adherence LogsThe experimental group participants will be recorded on their personal smartphone performing their prescribed exercises with individualized instruction from the participating physical therapist. The prescribing therapist will record participants on their own smartphones doing the exercise program in the clinic so that participants can have that video recording of the exercises to help remind them how to do the exercises properly at home. Participants will not be asked to record themselves performing future exercise sessions as documentation of improvement. Intervention: Home Exercise Program and Adherence Logs |
| Conventional Printed Group | Active comparator | Other: Home Exercise Program and Adherence LogsThe active comparator group will receive individualized instruction from the participating physical therapist on how to perform their home exercise program as well as printed instructions of the exercises. No video recording of the control group participants will be performed. Intervention: Home Exercise Program and Adherence Logs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who can read and understand the English language,
- adults between 18-65 years of age,
- have a referral to an outpatient physical therapy clinic for an orthopaedic condition, and
- who own a smartphone with video recording capabilities and available data storage space (at least 500 MB or 0.5 GB).
Key exclusion criteria (4 listed)
- Individuals referred for non-orthopaedic conditions,
- individuals currently on an established, prescribed home exercise program,
- individuals requiring more than 4 home exercises at one time as part of their rehabilitation program, and
- individuals who do not own a smartphone device with the required storage and recording specifications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Exercise Program and Adherence LogsAlso: HEPBoth groups will receive physical therapy prescribed home exercises and be asked to record adherence to their program on an exercise log. | Other | Conventional Printed Group, Video Recording Group |
Primary outcome
Home Exercise Adherence
Time frame: Weekly for 6 weeks
Data will be recorded via a self-reported exercise log that includes number of days exercises were completed per week. Participants will record the number of days participants did "All" of the program (defined as doing 100% of their exercises), "Most" of the program (defined as doing 75% of their exercises), "Some" of the program (defined as doing 50% of their program, and "None" of the program (defined as doing 0% of their exercise program).
Results and safety
The study was stopped early (reason given: Data collection sites lost research personnel that were recruiting subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Background: PubMed 23667294Gonzalez JS, McCarl LA, Wexler D DD, Cagliero E, Delahanty L, Soper TD, Goldman V, Knauz R, Safren SA. Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in Type 2 Diabetes. J Cogn Psychother. 2010 Nov 1;24(4):329-343. doi: 10.1891/0889-8391.24.4.329.
- BackgroundHammer C, Degerfeldt L, Denison E. Mechanical diagnosis and therapy in back pain: Compliance and social cognitive theory. Adv Physiother. 2007;9(4):190-197.
- Background: PubMed 16301755Marks R, Allegrante JP. Chronic osteoarthritis and adherence to exercise: a review of the literature. J Aging Phys Act. 2005 Oct;13(4):434-60. doi: 10.1123/japa.13.4.434.
- Background: PubMed 17233546Papaioannou A, Kennedy CC, Dolovich L, Lau E, Adachi JD. Patient adherence to osteoporosis medications: problems, consequences and management strategies. Drugs Aging. 2007;24(1):37-55. doi: 10.2165/00002512-200724010-00003.
- Background: PubMed 22499542Conraads VM, Deaton C, Piotrowicz E, Santaularia N, Tierney S, Piepoli MF, Pieske B, Schmid JP, Dickstein K, Ponikowski PP, Jaarsma T. Adherence of heart failure patients to exercise: barriers and possible solutions: a position statement of the Study Group on Exercise Training in Heart Failure of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2012 May;14(5):451-8. doi: 10.1093/eurjhf/hfs048. Epub 2012 Apr 11.
- Background: PubMed 20091582Jordan JL, Holden MA, Mason EE, Foster NE. Interventions to improve adherence to exercise for chronic musculoskeletal pain in adults. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD005956. doi: 10.1002/14651858.CD005956.pub2.
- Background: PubMed 23791324Yuen HK, Wang E, Holthaus K, Vogtle LK, Sword D, Breland HL, Kamen DL. Self-reported versus objectively assessed exercise adherence. Am J Occup Ther. 2013 Jul-Aug;67(4):484-9. doi: 10.5014/ajot.2013.007575.
- Background: PubMed 24512976Holden MA, Haywood KL, Potia TA, Gee M, McLean S. Recommendations for exercise adherence measures in musculoskeletal settings: a systematic review and consensus meeting (protocol). Syst Rev. 2014 Feb 10;3:10. doi: 10.1186/2046-4053-3-10.
- Background: PubMed 24823959Kramer A, Dettmers C, Gruber M. Exergaming with additional postural demands improves balance and gait in patients with multiple sclerosis as much as conventional balance training and leads to high adherence to home-based balance training. Arch Phys Med Rehabil. 2014 Oct;95(10):1803-9. doi: 10.1016/j.apmr.2014.04.020. Epub 2014 May 10.
- Background: PubMed 8863761Friedrich M, Cermak T, Maderbacher P. The effect of brochure use versus therapist teaching on patients performing therapeutic exercise and on changes in impairment status. Phys Ther. 1996 Oct;76(10):1082-8. doi: 10.1093/ptj/76.10.1082.
- Background: PubMed 2526364Harkapaa K, Jarvikoski A, Mellin G, Hurri H. A controlled study on the outcome of inpatient and outpatient treatment of low back pain. Part I. Pain, disability, compliance, and reported treatment benefits three months after treatment. Scand J Rehabil Med. 1989;21(2):81-9.
- Background: PubMed 21960468Khalil H, Quinn L, van Deursen R, Martin R, Rosser A, Busse M. Adherence to use of a home-based exercise DVD in people with Huntington disease: participants' perspectives. Phys Ther. 2012 Jan;92(1):69-82. doi: 10.2522/ptj.20100438. Epub 2011 Sep 29.
- Individual participant dataSharing planned: No. All individual data will be reported as a group
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan J Petersen, PT, DSc study chair
University of the Incarnate Word
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Exercise Program and Adherence Logs in people with Adherence, run by Evan J. Petersen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Data collection sites lost research personnel that were recruiting subjects.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home Exercise Adherence (time frame: Weekly for 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02822755, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.