| CTRI Number |
CTRI/2021/08/035492 [Registered on: 06/08/2021] Trial Registered Prospectively |
| Last Modified On: |
16/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of PNF stretching and chest mobility exercises in Covid-19 survivors |
|
Scientific Title of Study
|
"Effect of PNF Pectoral Stretching and Chest Mobility Exercises on Chest Expansion,Fatigue and Pulmonary Functions in Covid-19 Survivors" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Merin Shaji |
| Designation |
PG student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Dr. D.Y. Patil College of Physiotherapy, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
"C"19 Sukhwani Plaza, Akurdi Pune 411035
Pune
MAHARASHTRA
411018
India |
| Phone |
7276656965 |
| Fax |
|
| Email |
drmerin98.pt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Gohil |
| Designation |
Associate Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Dr. D.Y. Patil College of Physiotherapy, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Dr. D.Y. Patil College of Physiotherapy, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7767828290 |
| Fax |
|
| Email |
divya.gohil@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Merin Shaji |
| Designation |
PG student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Dr. D.Y. Patil College of Physiotherapy Dr. D. Y. Patil Vidyapeeth Pimpri Pune
Dr. D.Y. Patil College of Physiotherapy Dr. D. Y. Patil Vidyapeeth Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7276656965 |
| Fax |
|
| Email |
drmerin98.pt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructure support- study is being conducted at Dr.D.Y.Patil college of Physiotherapy, Pune |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [not applicable] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divya Gohil |
Dr. D. Y. Patil College of Physiotherapy, Dr. D. Y. Patil Vidyapeeth |
Dr. D. Y. Patil College of Physiotherapy Dr. D. Y. Patil Vidyapeeth Pimpri Pune
Pune
MAHARASHTRA |
7767828290
divya.gohil@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Of Dr. D. Y. Patil College of Physiotherapy, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chest mobility exercises |
Each exercises listed below will be repeated 6 times on each side with rest of period for 30 seconds in between. The intervention will be carried out for one week with total of 7 sessions. Each Exercise will be accompanied by breathing pattern. In neutral position of exercises, subjects will be asked to exhale during flexion, turning or extension subject would be asked to do inhale.
1. Rib rotation: Subject in supine lying, therapist standing on opposite side facing subject, stretches right side of chest placing hands on one side of rib cage and giving opposite directional forces and same will be performed on other side.
2. Passive lateral flexion in side lying on pillows: Subject lying on one side on 2 pillows Therapist stretches the upper side of thorax with shoulder abduction. The same exercise will be repeated on other side.
3. Trunk rotation in sitting position: Active and passive trunk rotation on both sides were performed. Exhalation in a forward position will be carried out at the beginning of flexion, and rotation of the left side will be performed laterally with inspiration.
4. Direct rib stretching: Subject in supine lying with arms folded and hands clasped on back of neck, therapist performs flexion and extension of the subject thorax.
|
| Comparator Agent |
PNF Pectoral Stretching |
Hold-relax PNF Stretching
subject will be asked to contract the pectoral muscles to move the limb into the direction of glenohumeral horizontal flexion, in the maintained position to meet the 50-60% resistance applied by the therapist. This isometric contraction will be held for 6sec. Patient then relaxed and passive stretch in the opposite direction.
6 times with rest period of 30sec |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Post Covid patients with mild and moderate recovery-
Asymptomatic
Does not need oxygen support on exercise or activity
MMRC dyspnea grade <2
Subjects who are independent in mobility
Subjects willing to participate.Â
Duration : 6-8 months after recovery
Baseline values for chest expansion:
Upper thoracic: male- 2.6+1.4cm
female- 2.2+1.2cm
Lower thoracic: male- 2.3+1.1.2cm
female- 1.7+1.1cm
|
|
| ExclusionCriteria |
| Details |
Any musculoskeletal disorders affecting upper limb.
Any pathological condition affecting muscle, joint and bone Such as rheumatoid arthritis, severe osteoporosis.
Cardiovascular dysfunction (eg, ischemic heart disease, uncontrolled hypertension)
Additional conditions restricting chest expansion. (eg, obesity, severe scoliosis, ankylosing spondylitis)
Recent chest or abdominal surgery.
Pathology of spine such as disc protrusion, spondylolisthesis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary Function-Spirometry |
7 sessions/1week.
pulmonary function will be assesed with spirometry on the first session and after the last session. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Chest Expansion-Inch Tape |
It will be assessed before the first session on day1 and after the last session on day7. |
| Fatigue |
VAS for fatigue |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/08/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Will start with the publication procedure once the study gets completed. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Recent evidence suggests that the lungs are the organ most affected by COVID-19 with different pathophysiological events. In a study conducted by Elif Hocaoglu,et al ,it was found that the CT-derived measurements of the pectoralis muscle can be useful in predicting disease severity and mortality rate of COVID19 pneumonia in adult patients. Suitable lengthening of soft tissue around the chest wall and respiratory muscles is required for efficiency of contraction force of respiratory muscles and chest movement. Symptoms are often ignored by patient over a period of time once they are tested negative. Symptom most commonly noticed are fatigue and shortness of breath which may last upto many months. It has also been reported that the individuals ignore the mild symptoms and not focus on cardiorespiratory fitness. Researches have also proved the Chest PNF has been effective in COPD which have similar symptoms as that of COVID. Physiotherapy based rehabilitation program is an essential component for post COVID-19 patients in facilitating maximum functional recovery. As the disease affects lung, the respiratory muscles are also involved. This would further affect the chest expansion and the pulmonary function. PNF stretching for subject appears to be safe and effective in chronic respiratory patients with adaptive shortening and stiffness around the upper limb muscle treatment. Hence, the purpose of this study is to find the effect of Hold-relax PNF stretching and chest mobility exercises on pulmonary function test such as FEV1, FVC, FEV1/FVC ratio, fatigue and chest expansion for post COVID-19 survivors. |