KyphosisNCT04143464
The Effectiveness of Exercise on Reducing the Angle of Kyphosis
A study testing Kyphosis-specific exercise class and kyphosis-specific exercise videos in people with Kyphosis, run by The University of Hong Kong at 2 sites in 2 countries.
Trial summary
Thoracic hyperkyphosis, an exaggerated curvature between the first thoracic vertebra body (T1) and the 12th thoracic vertebra body (T12), has a high prevalence among older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kyphosis
- What is being tested?
- Kyphosis-specific exercise class and kyphosis-specific exercise videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2021to 1 Sep 2022
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chinese;
- Aged 60 years and above;
- No cognitive impairment or communication problems;
- The angle of thoracic kyphosis > 40° measured by Manual Inclinometer;
- Able to decrease the angle of kyphosis of 5° while standing.
Who cannot join
- Having central or peripheral neuropathy (this may affect balance);
- Taking drugs that affect the nervous system or affect balance and strength;
- Having untreated severe heart and lung disease (this may affect cardiopulmonary function);
- Having a history of spinal fracture (this may increase the risk of injury);
- Having surgery in spinal, shoulder, and pelvis in the past year or having plan to do so in the coming six month (this may increase the risk of injury);
- Having scoliosis ≥ 10°;
- Having done any specific therapeutic exercise for posture in the past year or having plan to do so in the coming six month (may affect the study result).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site
Liyuan Hospital of Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 000000
Yong Dai, daiyong_liyuanhospital@outlook.com
Hong Kong1 site
The University of Hong Kong
Hong Kong
Weiying Li, 39176605 ext. 852, u3003886@hku.hk
About this study
Official title: The Effectiveness of Kyphosis-specific Exercise on Reducing the Angle of Kyphosis Among Chinese Older Adults With Thoracic Hyperkyphosis - a Randomized Control Trial
Thoracic hyperkyphosis, an exaggerated curvature between the first thoracic vertebra body (T1) and the 12th thoracic vertebra body (T12), has a high prevalence among older adults. The cross-sectional study conducted by the Principal Investigator found 72% of older adults in the Chinese community have thoracic hyperkyphosis.
Thoracic kyphosis has been found having negative effects on self-image, physical function, respiratory function, pain, balance, and gait performance. Treatment options of thoracic hyperkyphosis included surgery, peptides injection, menopausal hormone therapy, bracing, traditional Chinese medicine therapies, and exercise.
Read more
The previous studies reported that different types of exercise such as strength training, pilates, yoga, and corrective exercise were effective in reducing the thoracic hyperkyphosis. However, the previous studies either excluded older adults who have exercise habits or lack of information about participants' daily activity levels. Besides, all the group spine exercise interventions in previous studies were delivered by professional trainers or physical therapists in the form of face-to-face exercise classes.
The current RCT will be conducted to provide kyphosis-specific exercise in the form of short video and face to face exercise classes as the intervention to Chinese older adults with thoracic hyperkyphosis. The RCT can test the effects of such kyphosis-specific exercise intervention on the angle of kyphosis, physical performance, pain, and self-image among Chinese older adults with thoracic hyperkyphosis. The investigator hypotheses that older adults receive kyphosis-specific exercise intervention (video and exercise class) have reduced the angle of kyphosis. And older adults receive kyphosis-specific exercise intervention (video and exercise class) have decreased pain, better self-image, and improved overall physical performance.
Read the detailed description
Thoracic hyperkyphosis, an exaggerated curvature between the first thoracic vertebra body (T1) and the 12th thoracic vertebra body (T12), has a high prevalence among older adults. The cross-sectional study conducted by the Principal Investigator found 72% of older adults in the Chinese community have thoracic hyperkyphosis.
Thoracic kyphosis has been found having negative effects on self-image, physical function, respiratory function, pain, balance, and gait performance. Treatment options of thoracic hyperkyphosis included surgery, peptides injection, menopausal hormone therapy, bracing, traditional Chinese medicine therapies, and exercise.
The previous studies reported that different types of exercise such as strength training, pilates, yoga, and corrective exercise were effective in reducing the thoracic hyperkyphosis. However, the previous studies either excluded older adults who have exercise habits or lack of information about participants' daily activity levels. Besides, all the group spine exercise interventions in previous studies were delivered by professional trainers or physical therapists in the form of face-to-face exercise classes.
The exercise protocol used by the current RCT was based on that developed by Katzmen and team. The previous studies using the same protocol reported three to five degrees decrease in the angle of kyphosis. Current RCT provides kyphosis-specific exercise in the form of short video and face to face exercise classes. The intervention of the proposed study contains two parts. One is the group kyphosis-specific exercise class given by a certified physical trainer. Another is the home practice following kyphosis-specific exercise videos. The intervention arrangement is : 1. Group learning and practice: a 1-hour kyphosis-specific exercise training session will be provided two times in the first week; 2. Weekly follow-up: a 1-hour kyphosis-specific exercise will be conducted with reinforcement of learning and remedial teaching by a certified physical trainer once a week for five consecutive weeks after the group learning and practice; 3. Self-practice: the participant will following the kyphosis-specific exercise videos doing self-practice every day for the whole intervention period lasting 6 weeks.
The group kyphosis-specific exercise class will be led by a licensed physical trainer and a trained assistant. The participant to instructor (assistant) ratio will no less than 5:1. The content of kyphosis-specific exercise videos is the same as an exercise class.
The participants are to be selected from the communities located in different regions in Wuhan by convenient sampling. Every potential participant will have a trained research assistant responsible for explaining the RCT details with the information sheet and re-assuring the respondents that data collected in the study will be kept strictly confidential, and then seeking permission for conducting the screening. The potential participants will be screened according to inclusion and exclusion criteria. The eligible participants will sign the written consent and accomplish the baseline questionnaire and assessments (T0). After that, the participant will be randomly divided into the intervention group or the control group.
A block randomization method will be used. The investigator will randomly select block sizes such as two, four, or six, to make randomization sequences for 156 participants (sample size calculation results). Then randomization sequences will be printed and placed in a sequentially numbered opaque sealed envelope. After older adult sign consent and finishing the baseline questionnaire and assessments, the researcher will open the envelope according to the numbered sequence for the grouping allocation.
The intervention group will receive a group kyphosis-specific exercise class, kyphosis-specific exercise video, and a logbook. Before every exercise class, the researcher will send them time and location as reminders. Class attendance is recorded every time. The participants are asked to record the time of home kyphosis-specific exercise practice and other daily exercises. The participants will also be encouraged to write down questions or comments in the logbook. The investigator will check the logbook and respond once a week. The Control group will receive a booklet introducing general health education material, and a logbook recording the time of daily exercises. After the end of 6 weeks of intervention, all participants will be invited to finish the postintervention assessment (T1). The data will be analyzed according to the intention to treat after T0 and T1.
- Conditions
- Kyphosis
- Being tested
- Kyphosis-specific exercise class and kyphosis-specific exercise videos
- Keywords
- Thoracic Hyperkyphosis, Exercise, Older Adults
- Medical subject headings
- Kyphosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kyphosis-specific exercise class and kyphosis-specific exercise videosBehavioural
The kyphosis-specific exercise is based on the protocol published by Katzman and team in 2016. It includes warm-up, back muscle strength training, spine mobility training, spine alignment training, and stretching. The class will last around 60 minutes.
The exercise videos have the same content as the kyphosis-specific exercise class. The participants are asked to practice everyday at home following the videos.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The participants in this group will receive group kyphosis-specific exercise classes given by the certified physical trainer and kyphosis-specific exercise videos.
The intervention arrangement is:
1. Group learning and practice: a 1-hour kyphosis-specific exercise training session will be provided two times in the first week,
2. Weekly follow-up: a 1-hour kyphosis-specific exercise will be conducted with reinforcement of learning and remedial teaching by a certified physical trainer once a week for five consecutive weeks after the group learning and practice,
3. Self-practice: the participant will following the kyphosis-specific exercise videos doing self-practice every day for the whole intervention period lasting six weeks. Receives: Behavioral: Kyphosis-specific exercise class and kyphosis-specific exercise videos |
| Control group | No intervention | No special arrangement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the angle of kyphosis in degrees
Measured by manual inclinometer which have previously demonstrated excellent levels of inter-rater (ICC=0.90), and intra-rater reliability (ICC=0.92), and satisfied concurrent validity (r=0.86).
Measured: Baseline and after six weeks' intervention
Secondary outcomes (5)
The time change of one leg standing in seconds (Balance)
Measured by One-leg Standing Test
Measured: Baseline and after six weeks' intervention
The time change of up and go by seconds (Balance)
Measured by Timed Up \& Go Test
Measured: Baseline and after six weeks' intervention
The bust change in breathing by centimeters (Cardiopulmonary function)
Measured by Thoracic Expansion test
Measured: Baseline and after six weeks' intervention
The distance change of walking by meters (Cardiopulmonary function)
the Six Minutes Walking Test
Measured: Baseline and after six weeks' intervention
The gait performance change by gait score
Measured by the Farsi Version of Functional Gait Assessment
Measured: Baseline and after six weeks' intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Jun 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KyphosisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ms Weiying Li, The University of Hong Kong
- Investigators
- Weiying Li, Mphil, Principal investigator, PhD student, School of Nursing, the University of Hong KongYong Dai, Study director, Supervisor Nurse, Public Health Department, Liyuan Hospital of Tongji Medical College of Huazhong University of Science & Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143464
- Sponsor's protocol ID
- [2019] IEC (P001)
- Status last verified
- Sep 2020
- First submitted
- 10 Oct 2019
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan for sharing
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Kyphosis-specific Exercise on Reducing the Angle of Kyphosis Among Chinese Older Adults With Thoracic Hyperkyphosis - a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04143464
- Acronym / sponsor ID
- [2019] IEC (P001)
- Conditions
- Kyphosis
- Keywords
- Thoracic Hyperkyphosis, Exercise, Older Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 29 Oct 2019 (actual)
- 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.
Thoracic hyperkyphosis, an exaggerated curvature between the first thoracic vertebra body (T1) and the 12th thoracic vertebra body (T12), has a high prevalence among older adults. The cross-sectional study conducted by the Principal Investigator found 72% of older adults in the Chinese community have thoracic hyperkyphosis.
Thoracic kyphosis has been found having negative effects on self-image, physical function, respiratory function, pain, balance, and gait performance. Treatment options of thoracic hyperkyphosis included surgery, peptides injection, menopausal hormone therapy, bracing, traditional Chinese medicine therapies, and exercise.
The previous studies reported that different types of exercise such as strength training, pilates, yoga, and corrective exercise were effective in reducing the thoracic hyperkyphosis. However, the previous studies either excluded older adults who have exercise habits or lack of information about participants' daily activity levels. Besides, all the group spine exercise interventions in previous studies were delivered by professional trainers or physical therapists in the form of face-to-face exercise classes.
The current RCT will be conducted to provide kyphosis-specific exercise in the form of short video and face to face exercise classes as the intervention to Chinese older adults with thoracic hyperkyphosis. The RCT can test the effects of such kyphosis-specific exercise intervention on the angle of kyphosis, physical performance, pain, and self-image among Chinese older adults with thoracic hyperkyphosis. The investigator hypotheses that older adults receive kyphosis-specific exercise intervention (video and exercise class) have reduced the angle of kyphosis. And older adults receive kyphosis-specific exercise intervention (video and exercise class) have decreased pain, better self-image, and improved overall physical performance.
Detailed description
Thoracic hyperkyphosis, an exaggerated curvature between the first thoracic vertebra body (T1) and the 12th thoracic vertebra body (T12), has a high prevalence among older adults. The cross-sectional study conducted by the Principal Investigator found 72% of older adults in the Chinese community have thoracic hyperkyphosis.
Thoracic kyphosis has been found having negative effects on self-image, physical function, respiratory function, pain, balance, and gait performance. Treatment options of thoracic hyperkyphosis included surgery, peptides injection, menopausal hormone therapy, bracing, traditional Chinese medicine therapies, and exercise.
The previous studies reported that different types of exercise such as strength training, pilates, yoga, and corrective exercise were effective in reducing the thoracic hyperkyphosis. However, the previous studies either excluded older adults who have exercise habits or lack of information about participants' daily activity levels. Besides, all the group spine exercise interventions in previous studies were delivered by professional trainers or physical therapists in the form of face-to-face exercise classes.
The exercise protocol used by the current RCT was based on that developed by Katzmen and team. The previous studies using the same protocol reported three to five degrees decrease in the angle of kyphosis. Current RCT provides kyphosis-specific exercise in the form of short video and face to face exercise classes. The intervention of the proposed study contains two parts. One is the group kyphosis-specific exercise class given by a certified physical trainer. Another is the home practice following kyphosis-specific exercise videos. The intervention arrangement is : 1. Group learning and practice: a 1-hour kyphosis-specific exercise training session will be provided two times in the first week; 2. Weekly follow-up: a 1-hour kyphosis-specific exercise will be conducted with reinforcement of learning and remedial teaching by a certified physical trainer once a week for five consecutive weeks after the group learning and practice; 3. Self-practice: the participant will following the kyphosis-specific exercise videos doing self-practice every day for the whole intervention period lasting 6 weeks.
The group kyphosis-specific exercise class will be led by a licensed physical trainer and a trained assistant. The participant to instructor (assistant) ratio will no less than 5:1. The content of kyphosis-specific exercise videos is the same as an exercise class.
The participants are to be selected from the communities located in different regions in Wuhan by convenient sampling. Every potential participant will have a trained research assistant responsible for explaining the RCT details with the information sheet and re-assuring the respondents that data collected in the study will be kept strictly confidential, and then seeking permission for conducting the screening. The potential participants will be screened according to inclusion and exclusion criteria. The eligible participants will sign the written consent and accomplish the baseline questionnaire and assessments (T0). After that, the participant will be randomly divided into the intervention group or the control group.
A block randomization method will be used. The investigator will randomly select block sizes such as two, four, or six, to make randomization sequences for 156 participants (sample size calculation results). Then randomization sequences will be printed and placed in a sequentially numbered opaque sealed envelope. After older adult sign consent and finishing the baseline questionnaire and assessments, the researcher will open the envelope according to the numbered sequence for the grouping allocation.
The intervention group will receive a group kyphosis-specific exercise class, kyphosis-specific exercise video, and a logbook. Before every exercise class, the researcher will send them time and location as reminders. Class attendance is recorded every time. The participants are asked to record the time of home kyphosis-specific exercise practice and other daily exercises. The participants will also be encouraged to write down questions or comments in the logbook. The investigator will check the logbook and respond once a week. The Control group will receive a booklet introducing general health education material, and a logbook recording the time of daily exercises. After the end of 6 weeks of intervention, all participants will be invited to finish the postintervention assessment (T1). The data will be analyzed according to the intention to treat after T0 and T1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Kyphosis-specific exercise class and kyphosis-specific exercise videosThe participants in this group will receive group kyphosis-specific exercise classes given by the certified physical trainer and kyphosis-specific exercise videos. The intervention arrangement is: 1. Group learning and practice: a 1-hour kyphosis-specific exercise training session will be provided two times in the first week, 2. Weekly follow-up: a 1-hour kyphosis-specific exercise will be conducted with reinforcement of learning and remedial teaching by a certified physical trainer once a week for five consecutive weeks after the group learning and practice, 3. Self-practice: the participant will following the kyphosis-specific exercise videos doing self-practice every day for the whole intervention period lasting six weeks. |
| Control group | No intervention | –No special arrangement |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese;
- Aged 60 years and above;
- No cognitive impairment or communication problems;
- The angle of thoracic kyphosis > 40° measured by Manual Inclinometer;
- Able to decrease the angle of kyphosis of 5° while standing.
Key exclusion criteria (7 listed)
- Having central or peripheral neuropathy (this may affect balance);
- Taking drugs that affect the nervous system or affect balance and strength;
- Having untreated severe heart and lung disease (this may affect cardiopulmonary function);
- Having a history of spinal fracture (this may increase the risk of injury);
- Having surgery in spinal, shoulder, and pelvis in the past year or having plan to do so in the coming six month (this may increase the risk of injury);
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 |
|---|---|---|
| Kyphosis-specific exercise class and kyphosis-specific exercise videosThe kyphosis-specific exercise is based on the protocol published by Katzman and team in 2016. It includes warm-up, back muscle strength training, spine mobility training, spine alignment training, and stretching. The class will last around 60 minutes. The exercise videos have the same content as the kyphosis-specific exercise class. The participants are asked to practice everyday at home following the videos. | Behavioural | Intervention group |
Primary outcome
The change of the angle of kyphosis in degrees
Time frame: Baseline and after six weeks' intervention
Measured by manual inclinometer which have previously demonstrated excellent levels of inter-rater (ICC=0.90), and intra-rater reliability (ICC=0.92), and satisfied concurrent validity (r=0.86).
5 secondary outcomes
The time change of one leg standing in seconds (Balance)
Time frame: Baseline and after six weeks' intervention
The time change of up and go by seconds (Balance)
Time frame: Baseline and after six weeks' intervention
The bust change in breathing by centimeters (Cardiopulmonary function)
Time frame: Baseline and after six weeks' intervention
The distance change of walking by meters (Cardiopulmonary function)
Time frame: Baseline and after six weeks' intervention
The gait performance change by gait score
Time frame: Baseline and after six weeks' intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Individual participant dataSharing planned: No. No plan for sharing
Related trials for Kyphosis
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Basic Body Awareness Therapy (BBAT) and Corrective Exercise for Adolescent Hyperkyphosis
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Surface Electromyographic Analysis of Scapular Stabilizer Muscle in Postural Hyperkyphosis
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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Kinesio Taping in Young Adults With Thoracic Hyperkyphosis
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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.
Weiying Li, Mphil principal investigator
PhD student, School of Nursing, the University of Hong Kong
Yong Dai study director
Supervisor Nurse, Public Health Department, Liyuan Hospital of Tongji Medical College of Huazhong University of Science & Technology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kyphosis-specific exercise class and kyphosis-specific exercise videos in people with Kyphosis, run by The University of Hong Kong at 2 sites in 2 countries.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiying Li, Mphil (39176605 ext. 852, u3003886@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of the angle of kyphosis in degrees (time frame: Baseline and after six weeks' intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2020.