The Effectiveness of Kyphosis-specific Exercise on Reducing the Angle of Kyphosis Among Chinese Older Adults With Thoracic Hyperkyphosis - a Randomized Control Trial
Phase: NA
Conditions: Kyphosis
Sponsor: The University of Hong Kong

 
Study Protocol 
 
 
The effectiveness of kyphosis-specific exercise on reducing the 
angle of kyphosis among Chinese older adults with thoracic 
hyperkyphosis — a randomized control trial 
 
 
 
 
 
 
IRB ID: [2019] IEC (P001) 
Data: 2019/10/9 
 
 
 
 
 
 
 

1. Investigators 
Principal Investigator (PI) 
Ms. Weiying Li, PhD candidate, School of Nursing, LKS Faculty of Medicine, The 
University of Hong Kong. 
 
Co-investigator (Co-I) 
Dr. Pui Hing CHAU, Associate Professor, School of Nursing, LKS Faculty of 
Medicine, The University of Hong Kong. 
2. Aims of the project  
The primary aim of the proposed randomized control trial is to investigate the 
effect of a kyphosis-specific exercise intervention on reducing the angle of kyphosis 
in Chinese older adults with thoracic hyperkyphosis. The secondary aim of this trial 
is to evaluate the effect of the kyphosis-specific exercise intervention on improving 
the self-image, pain, and physical performance in Chinese older adults with 
thoracic hyperkyphosis. 
 
3. Study sites 
Participants will be recruited from the community centers in Wuhan, China. 
4. Planned sample size 
It is planned to recruit 156 participants, and 20 participants for pilot.  
5. Measurements 
The participants meeting the inclusion criteria will be arranged to finish spine 
measurements, physical performance tests, and questionnaires (Appendix 1). 
 
6.1 Spine measurements (Primary outcome) 

The angle of kyphosis will be measured by manual inclinometer in the 
proposed study. There are two reasons we do not use X-ray, the gold standard. First, 
the study will be conducted in community centres without access to the X-ray 
facilities. Second, the participants will accomplish the angle of kyphosis 
measurement in two postures in three time points within 12 weeks. Manual 
measurements can protect the participants from exposing to unnecessary 
radiation.  
Manual inclinometer is have previously demonstrated excellent levels of inter-
rater (ICC=0.90), and intra-rater reliability (ICC=0.92) (Barrett, McCreesh, & Lewis, 
2013), and satisfied concurrent validity (r=0.86) (Barrett, Lenehan, O'Sullivan, 
Lewis, & McCreesh, 2018).  
The angle of kyphosis will be measured in two conditions, once in participants 
standing relaxed, once in participants stand as straight as possible. The 
measurement procedure is as follow: 1) the researcher explaining measuring 
instructions; 2) participants exposing upper body in two standing posture; 3) 
identifying and marking the spinous processes of C7, T1, T2, T12, and L1 in two 
postures; 4) using manual inclinometers measure the angle in two postures. The 
measurements will also be performed three times in succession. 
 
6.2 Physical performance assessments (Secondary outcomes) 
The physical performance assessments include two balance tests, One-leg 
Standing Test and Timed Up & Go Test; two cardiopulmonary function tests, the 
Thoracic Expansion test and the Six Minutes Walking Test; and a gait assessment, 
the Farsi Version of Functional Gait Assessment. All have been reported having 
satisfying validity and reliability (Kamrani, Seyed Hojjat Zamani Sani, Rezaie, & 
Aghdasi, 2010; Michikawa, Nishiwaki, Takebayashi, & Toyama, 2009; Wrisley, 
Marchetti, Kuharsky, & Whitney, 2004; Hu, Nan Liu, & Zhou, 2014).  
 
6.3 Questionnaires (Secondary outcomes) 
Participants will also be given a set of questionnaires asking social-

demographic information and health-related information. Social-demographic 
information includes age, gender, marital status, and education level. The health-
related information asks spine surgery history, illnesses, daily life posture, daily 
exercises level (via the International Physical Activity Questionnaire-Short Form) 
(Deng, Macfarlane, Thomas, Lao, Jiang, & Cheng, 2008). The self-image and pain 
will be measured via Scoliosis Patient Questionnaire - version 22 which has been 
found suiting for the evaluation of thoracic hyperkyphosis patients (Petcharaporn, 
Pawelek, Bastrom, Lonner, & Newton, 2007) and having a validated Chinese 
version (Cheung et al., 2007). The height and weight of participants will also be 
recorded in the questionnaire after measurement.  
6. Estimated duration and commencement date 
 Proposed starting date:         19/08/2019 
 Proposed study completion date:  01/03/2021 
 Expected final report date:   
01/09/2021 
 
7. Scientific/historical background 
Thoracic hyperkyphosis refers to an exaggerated curvature between the first 
thoracic vertebra body (T1) and the 12th thoracic vertebra body (T12) (Katzman, 
Wanek, Shepherd, & Sellmeyer, 2010) has a high prevalence among older adults. 
Studies reported that the prevalence of the thoracic hyperkyphosis in elderly 
ranged from 20% to 40% among community-dwelling subjects aged ≥ 60 years 
(Hinman, 2004; Kado, Huang, Karlamangla, Barrett-Connor, & Greendale, 2004; 
Takahashi et al., 2005). The cross-sectional study conducted by the Principal 
Investigator found thoracic hyperkyphosis have a high prevalence (72%) in Chinese 
community-dwelling older adults.  
Thoracic kyphosis has been found having negative effects on health. An 
increased angle of thoracic kyphosis was related to decreased self-image 
diminished physical function, impairment of respiratory function, increased 

chronic upper back pain, decreased balance, decreased quality of life, and 
decreased gait performance (Petcharaporn et al., 2007; Huang, Barrett, Greendale, 
& Kado, 2006; Kado, 2017; Kado, Huang, Barrett, & Greendale, 2005; Sangtarash, 
Manshadi, & Sadeghi, 2015).  
Treatment options of thoracic hyperkyphosis included surgery (Katzman, 
Wanek, Shepherd, & Sellmeyer, 2010), peptides injection (Liu, Wu, & Li, 2004), 
menopausal hormone therapy (Woods et al., 2018), bracing (Zaina et al., 2009), 
traditional Chinese medicine therapies (Shen, 2011). Exercise, a noninvasive and 
less pain treatment method, has also been conducted for relieving thoracic hyper-
kyphosis abnormality (Seidi, Rajabi, Ebrahimi, Alizadeh, & Minoonejad, 2014; 
Senthil, Sudhakar, Radhakrishnan, & Jeyakumar, 2017).  
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 (Greendale, Huang, Karlamangla, Seeger, & Crawford, 2009; 
Katzman et al., 2010). Investigator conducted a systematic review in order to 
explore the most effective exercise intervention for thoracic hyperkyphosis 
correction.  
According to the systematic review, the most popular kyphosis-specific exercise 
protocol was designed by Katzman and team. There were two versions of the 
protocol, one published in 2007 (Katzman, Sellmeyer, Stewart, Wanek, & Hamel, 
2007), another published in 2016 (Katzman et al., 2016). One third of 12 selected 
studies used this protocol, and two of them reported the largest decrease of the 
angle of kyphosis. 
 Both of the two studies with largest angle change reported more than 5° angle 
decrease. One was pre-post cohort study conducted by Katzman and team (2007) 
reported from baseline to post-intervention, the angle of kyphosis decreased 6°±3° 
(p<0.001) in relaxed standing posture, and 5°±3° (p<0.001) decrease in best 
standing posture. Another one was RCT conducted by Bahrekazemi and colleagues 
(2017) used the protocol published in 2016. They found the intervention group 
having a 6.5° mean angle reduction within group (p<0.05), and a 6.8° mean angle 

reduction between groups (p<0.05). 
Another two studies also found a statistically significant change of the kyphotic 
angle. One RCT reported that within the intervention group, the angle of kyphosis 
decreased by 3.3° (95% CI −4.9, −1.7), compared to a decrease of 0.3° (95% CI −1.9, 
1.2) among controls (Katzman, Vittinghoff, et al., 2017). Another reported 
participants in the intervention group had a 3.8° (95% CI: −5.3 to −2.3) decrease in 
the angle of kyphosis while the control group had an insignificant change (1°, 95% 
CI: −0.5 to 2.4), between-group difference was 4.8° (p< 0.001) (Katzman, Parimi, et 
al., 2017). 
However, the 12 systematic review selected studies either excluded older 
adults have and exercise habit or lack of information about participants’ daily 
activity level. Thus there is a lack of information about the effectiveness of 
kyphosis-specific exercise intervention on reducing the angle of kyphosis in older 
adults having exercise habit. The cross-sectional study conducted by the Principal 
Investigator found that older adults in Wuhan, China were active in daily life that 
more than 92.5% of the participants with thoracic hyperkyphpsis reported 
moderate or high exercise intensity.  
Currently, multimedia education has been successfully employed in healthcare 
fields (Batuyong, Birks, & Beischer, 2012). For example, exercise video has been 
used to help patients mastering the pelvic floor muscle exercise (Crowe, Harbison, 
Wootten, Pillay, & Morrison, 2018), preventing shoulder problems (Park, & Song, 
2017), and enhance exercise adherence of patients with osteoarthritis of the knee 
(Tohyama, Chiba, Tadano, Ikoma, & Yasuda, 2010).  
Video is a promising method for giving exercise intervention to elderly. Because 
the video can provide accurate visual guidance on how to perform the exercises 
and, in addition, music and verbal instruction can be motivational during the 
exercises (Vestergaard, Kronborg, & Puggaard, 2013). Using video as intervention 
can also overcome the limitations on finance and transportation when the elderly 
wants professional exercise guidance. 
All the kyphosis-specific exercise interventions in reviewed studies by the 

Principal investigator were delivered by professional trainer or physical therapist 
in the form of face-to-face exercise class. No evidence shows whether the 
kyphosis-specific exercise intervention be given in the form of video also have 
effects on reducing the angle of kyphosis or enhancing the overall physical 
performance in older adults with thoracic hyperkyphosis. 
So, it is valuable to conduct the proposed study providing kyphosis-specific 
exercise in the form of video and face to face exercise class as intervention to 
Chinese older adults with thoracic hyperkyphosis. The proposed study 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. 
 
8. Research question and hypotheses  
9.1 research questions 
1) what are the effects of kyphosis-specific exercise intervention (video and 
exercise class) on the angle of kyphosis in Chinese elderly with thoracic 
hyperkyphosis, as compared with control?  
2) what are the effects of kyphosis-specific exercise intervention (video and 
exercise class) on pain, self-image, and physical performance, including gait 
performance, balance, and cardiopulmonary functions in Chinese elderly with 
thoracic hyperkyphosis?  
 
9.2 Hypothesis 
1) older adults receive kyphosis-specific exercise intervention (video and 
exercise class) have reduced the angle of kyphosis; 
2) older adults receive kyphosis-specific exercise intervention (video and 
exercise class) have decreased pain, better self-image, and improved the overall 
physical performance.  
 

9. Study design 
10.1 Study type 
The proposed study is a single blinded randomized control trial. The 
participants and kyphosis-specific exercise intervention instructor are not able to 
be blinded, while the people conducted assessments will be blinded for group 
allocation.  
 
10.2 Method of selection of subjects 
The target population will be elderly living in Wuhan, Mainland China. The 
older adults participated in the previous cross-sectional study conducted by the 
principle investigator will be first invited.  
Inclusion criteria for subjects to be screened are: 
1)  Chinese;  
2)  Aged 60 years and above;  
3)  No cognitive impairment or communication problems;  
4)  The angle of thoracic kyphosis > 40° measured by Manual Inclinometer; 
5)  Able to decrease the angle of kyphosis of 5° while standing. 
Exclusion criteria for subjects to be screened include: 
1)  Having central or peripheral neuropathy (this may affect balance); 
2)  Taking drugs that affect the nervous system or affect balance and strength; 
3) Having untreated severe heart and lung disease (this may affect 
cardiopulmonary function);  
4)  Having a history of spinal fracture (this may increase the risk of injury);  
5)  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); 
6)  Having scoliosis ≥ 10°; 
7)  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). 
 

10.3 Intervention design 
The intervention of the proposed study contains two parts. One is the kyphosis-
specific exercise class given by certified physical trainer. Another is the home 
practice following kyphosis-specific exercise video. The intervention arrangement 
is: 
l Group learning and practice: a 1-hour kyphosis-specific exercise training 
session will be provided two times in the first week, 
l 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 months after the group 
learning and practice,  
l Self-practice: participant will following the kyphosis-specific exercise 
video doing self-practice every day for the whole intervention period 
lasting 6 weeks.  
The 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 video is the same as exercise class.  
The kyphosis-specific exercise protocol is based on Kaztman’s studies published 
in 2007 and 2016 (Katzman, Sellmeyer, Stewart, Wanek, & Hamel, 2007; Katzman 
et al., 2016). The target group of these two studies were different. Participants 
included in 2007 were older and have more severe thoracic hyperkyphosis. In 2007 
women aged 65 and above with a thoracic of 50° and greater were included while 
in 2016 older adults in both genders aged 60 and above with a thoracic of 40° and 
greater were recruited. As the sample of the proposed study is similar to 2016 
protocol, the proposed study mainly follow the protocol published in 2016. 
The choices for the specific exercise were slightly different between the 
protocol in 2007 and 2016, but no information of revision was given. More 
exercises were included in 2016 protocol than that in 2007, but overhead arm wall 
slid and calf stretching were only mentioned in 2007 protocol. As the 2016 protocol 

already include full leg stretching exercise supine straight-leg raise, the calf 
stretching will not be included in the proposed study. Overhead arm wall slid has 
been found effectively improving scapular alignment (Kim & Lim, 2016) which is 
associated with spine alignment (Helgadottir, Kristjansson, Mottram, Karduna & 
Jonsson, 2011).The comprehensive intervention protocol is presented in Appendix 
2.  
 
10.4 Number of subjects to be recruited 
According to the systematic review, the effect size of four studies used 
Katzman’s kyphosis-specific exercise protocol ranged from 0.44 to 2.45 
(Bahrekazemi, et al., 2017; Katzman, Vittinghoff, et al., 2017; Katzman, Parimi, et 
al., 2017; Katzman, Sellmeyer, Stewart, Wanek, & Hamel, 2007). We expect the 
proposed RCT can attain similar effect size, hence for a more conservative estimate, 
effect size 0.44 (which was equivalent to intervention group had the angle of 
kyphosis 3.0°, 95% CI 0.56°-3° less than the controls) was taken into sample size 
calculation. Assuming the level of significance at 0.05 and power as 0.8, the 
calculated sample size will be in each group. The proposed study will recruit at 
least 78 participants in each group taking a drop-out rate of 20%. In the pilot study, 
20 eligible participants will be recruited. 
 
10.5 Procedures 
The participants are to be selected from the communities located in different 
regions in Wuhan by convenient sampling. The participants joined the cross-
sectional study conducted by principal investigator in 2018 will be first invited. The 
staff working in community centers will also send notice to the residents’ online 
chat room. Every potential participant will have a trained research assistant 
responsible for explaining the RCT details with the information sheet (Appendix 3) 
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 (Appendix 4). The eligible participants will sign the written consent 
(Appendix 5) and accomplish the baseline questionnaire and assessments (T0). 
After that the participant will be randomly divided into intervention group or 
control group.  
Block randomization method will be used (Kang, Ragan, & Park, 2008). The 
investigator will randomly select block sizes such as two, four, or six, to make 
randomization sequences for 156 participants. 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 envelop according to the numbered sequence for the 
grouping allocation.  
The intervention group will receive kyphosis-specific exercise class, kyphosis-
specific exercise video and a log book (sample page is shown in Appendix 6). 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. They 
can also write down questions about kyphosis-specific exercise in the log book. 
The investigator will check the log book and respond to the questions once a week. 
The Control group will receive a booklet introducing general health education 
material, and a log book recording the time of daily exercises (sample page is 
shown in Appendix 7).  
After the end of 6 weeks intervention, all participants will be invited to finish 
the postintervention assessment (T1). The flowchart of the proposed RCT is 
presented in Figure 1.  
 
 

Figure 1  The flowchart of proposed RCT 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
 
 
 
 
Assessed for eligibility  (n=156 ) 
Randomized (n=156 ) 
Allocated to exercise class group (n= 
78) 
• Received exercise class and exercise 
video 
•6 weeks intervention: 
l 
Week 1: 2 classes 
l 
Week 2-6: 1 class/day 
l 
Home practice: every day 
follow the video 
Allocated to control (n = 78) 
• Received general health 
education booklet 
6 weeks follow-up 
Baseline assessment (T0) 
Post intervention assessment (T1) 
Follow-up assessment (T2) 

10. Methods of statistical analysis 
The data will be analyzed according to intention to treat. Descriptive statistics 
will be used to explore the characteristics of the elderly.  
The primary outcome is the change in the angle of kyphosis. The secondary 
outcomes are the score change of pain and self-image, the change in score of the 
Farsi version of Functional Gait Assessment, change in time of the Timed Up and 
Go Test and the One Leg Standing Test, change in walking distance of the Six 
Minutes Walking Test, and change in length of the Chest Expansion test.   
T-test and Chi-square test will be used to determine any baseline differences 
among two intervention groups and one control group in terms of baseline socio-
demographics, regular exercise type and intensity, illness condition, and the angle 
of kyphosis.  
Linear mixed effect model will be conducted to explore the between-group and 
within-group differences in the outcomes across the time, while controlling socio-
demographics, illness condition, BMI, type and intensity of regular exercise. SPSS 
version 23.0 was used to analyze data collected, the significance level will be 0.05. 
 
11. Describe any unusual or discomforting procedures to be used 
Exposing the upper body in spine measurement may be embarrassing for some 
participants. In order to protect their privacy, the participant will be invited to a 
private room with air-conditioned, one at a time. The principal investigator and 
well-trained researcher helpers will perform the measurement. And the 
participants can stop measuring whenever they want to. For the measurement of 
physical fitness, participants may be tired. They can take a rest whenever they 
need.  
In kyphosis-specific exercise class, the instructor participants ratio will be no 
less than 1:5 to endure the participants’ safety. During exercise class, the 
participants can rest whenever they think is necessary. The first aid equipment will 

be prepared. In the video exercise group orientation, the investigator will give 
exercise safety instruction.  
Most of the exercises including in the kyphosis-specific exercise video are 
taking supine or prone posture, in order to prevent fall during exercise. In every 
follow up kyphosis-specific exercise classes, the certified physical trainer will 
reinforce safety instructions and exercise skills. The participants will be encouraged 
to contact the investigator whenever they have questions. No serious adverse 
event was reported by the previous studies letting older adults following exercise 
video doing home exercise.  
12. Are there any hazards associated with the investigation?    
No known potential hazards will be introduced to participants. 
 
13. Direct access to source data/documents 
The principal investigator is responsible for processing and storing the raw data 
during and after the completion of the study. Three copies of the raw data will be 
stored as encrypted files on the principal investigator’s computer, external hard 
drive, and reliable networked cloud.  
 
14. Consent  
In order to respect the principles of human dignity, when approaching the 
participants, the researcher will explain the purpose and steps of the study based 
on the information sheet (Appendix 3). The researcher will also emphasize that 
joining the study will be entirely voluntary and every participant has the right to 
withdraw or refuse to give information at any time during the study without 
incurring any penalties. Eligible participants will sign a consent form (Appendix 5).   
 
 

 
 
 
 
 
 
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