The Effectiveness of Exercise on Reducing the Angle of Kyphosis

NCT04143464 | Unknown DMC

• 1 other identifier: [2019] IEC (P001)
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 2

Brief 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. 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.

Conditions

Kyphosis

Keywords

Thoracic Hyperkyphosis; Exercise; Older Adults

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and after six weeks' intervention

Secondary Outcomes (5)

• The time change of one leg standing in seconds (Balance)

  Baseline and after six weeks' intervention

• The time change of up and go by seconds (Balance)

  Baseline and after six weeks' intervention

• The bust change in breathing by centimeters (Cardiopulmonary function)

  Baseline and after six weeks' intervention

• The distance change of walking by meters (Cardiopulmonary function)

  Baseline and after six weeks' intervention

• The gait performance change by gait score

  Baseline and after six weeks' intervention

Study Arms (2)

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.

Behavioral: Kyphosis-specific exercise class and kyphosis-specific exercise videos

Control group

NO INTERVENTION

No special arrangement

Interventions

Kyphosis-specific exercise class and kyphosis-specific exercise videos BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Liyuan Hospital of Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, 000000, China

Location

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Kyphosis; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior

Study Officials

• Weiying Li, Mphil

  PhD student, School of Nursing, the University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Yong Dai

  Supervisor Nurse, Public Health Department, Liyuan Hospital of Tongji Medical College of Huazhong University of Science & Technology

  STUDY DIRECTOR

Central Study Contacts

Weiying Li, Mphil

CONTACT

39176605; u3003886@hku.hk

Pui Hing Chau, PhD

CONTACT

39176626; phpchau@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 29, 2019
• Study Start: June 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); HK (1)