| CTRI Number |
CTRI/2024/12/077993 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Concentric vs Eccentric exercises in Achilles Tendinopathy |
|
Scientific Title of Study
|
IMPACT OF CONCENTRIC AND ECCENTRIC LOADING ON PAIN, RANGE OF MOTION AND FUNCTIONAL ABILITY IN PATIENTS WITH INSERTIONAL ACHILLES TENDINOPATHY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aman Siddiqui |
| Designation |
PG Scholar |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy
Amity Institute of Health Allied Sciences
Amity University
F1 LGF Sector 125 Noida
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
09990772725 |
| Fax |
|
| Email |
sidaman25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasobanta Sethi |
| Designation |
Director |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy
Amity Institute of Health Allied Sciences
Amity University
F1 LGF Sector 125 Noida
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
09988600462 |
| Fax |
|
| Email |
jsethi@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasobanta Sethi |
| Designation |
Director |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy
Amity Institute of Health Allied Sciences
Amity University
F1 LGF Sector 125 Noida
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
09988600462 |
| Fax |
|
| Email |
jsethi@amity.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy
Amity Institute of Health Allied Sciences Amity University F1 LGF sector 125 Noida
Uttar Pradesh
PIN 201313
India |
|
|
Primary Sponsor
|
| Name |
Aman Siddiqui |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh PIN 201313 India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jasobanta Sethi |
Amity Institute of Health Allied Sciences |
Department of Physiotherapy Amity Institute of Health Allied Sciences
Amity University
F1 LGF Sector 125 Noida Uttar pradesh
PIN 201313
Gautam Buddha Nagar
UTTAR PRADESH |
9988600462
jsethi@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Department of Physiotherapy,Amity Institute of Health Allied Sciences, Amity University, Noida, Uttar Pradesh |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M778||Other enthesopathies, not elsewhere classified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Combined Concentric and Eccentric Exercises (Group C) |
Initial Phase:
In the Initial Phase, Group C performs both Concentric and Eccentric Heel Raises and Drops. This involves standing on the edge of a step, rising onto the toes (concentric), and lowering the heels slowly (eccentric). The exercise is done for 3 sets of 15 repetitions, 3 times per day, with 2 minutes rest between sets. The total time for this exercise is 10 minutes each session, with low intensity.
Intermediate Phase:
In the Intermediate Phase, Group C progresses to performing Both Concentric and Eccentric Heel Raises and Drops on One Leg. The individual performs the concentric heel raises and eccentric heel drops on one leg to increase intensity. This is done for 3 sets of 12 repetitions, 3 times per day, with 2 minutes rest between sets. The total time for this exercise is 12 minutes each session, with moderate intensity.
Advanced Phase:
In the Advanced Phase, Group C adds weight or resistance to the exercise, performing Both Concentric and Eccentric Heel Raises and Drops with Load. This involves adding resistance (e.g., weights or resistance bands) to both movements. The exercise is done for 3 sets of 10 repetitions, 3 times per day, with 2 minutes rest between sets. The total time for this exercise is 15 minutes each session, and the intensity is high. |
| Intervention |
Concentric loading (Group A) |
The Silbernagel protocol is a progressive exercise program for Achilles tendinopathy. While it typically includes both eccentric and concentric loading, focusing solely on these aspects can still provide valuable insight. Concentric loading exercises involve muscle shortening during force production (e.g., raising the heel), promoting strength. Eccentric loading exercises involve muscle lengthening under tension (e.g., lowering the heel slowly), aiding tendon repair and strength. Both types are crucial for improving tendon health, reducing pain, and enhancing overall movement, especially in conditions like Achilles tendinopathy. This exercise plan progresses through initial, intermediate, and advanced phases with increasing intensity and complexity. Exercises focus on concentric and eccentric movements to strengthen the calves and improve ankle stability.
Group A (Concentric Exercises):
Initial Phase:
In the Initial Phase, Group A performs Concentric Heel Raises. The exercise involves standing on both feet, rising onto the toes, and then lowering the heels back slowly. This is done for 3 sets of 15 repetitions, 3 times per day, with 2 minutes rest between sets. The total time for this exercise is 10 minutes each session. The intensity is low.
Intermediate Phase:
In the Intermediate Phase, Group A progresses to Single-Leg Concentric Heel Raises. The exercise is performed on one leg to increase the challenge. It is done for 3 sets of 12 repetitions, 3 times per day, with 2 minutes rest between sets. The total time for this exercise is 12 minutes each session, with a moderate intensity.
Advanced Phase:
In the Advanced Phase, Group A adds resistance to the exercise, performing Concentric Heel Raises with Load. This could involve adding weights or resistance bands to increase the difficulty. It is done for 3 sets of 10 repetitions, 3 times per day, with 2 minutes rest between sets. The total time for this exercise is 15 minutes each session, and the intensity is high.
|
| Comparator Agent |
Eccentric loading (Group B) |
Group B (Eccentric Exercises):
Initial Phase:
In the Initial Phase, Group B performs Eccentric Heel Drops. To perform this exercise, stand on the edge of a step, lower the heels slowly, and then rise on both feet. This is done for 3 sets of 15 repetitions, 3 times per day, with 2 minutes rest between sets. The total time for this exercise is 10 minutes each session. The intensity is low.
Intermediate Phase:
In the Intermediate Phase, Group B advances to Single-Leg Eccentric Heel Drops. This exercise is performed on one leg to further challenge balance and strength. It is done for 3 sets of 12 repetitions, 3 times per day, with 2 minutes rest between sets. The total time for this exercise is 12 minutes each session, with moderate intensity.
Advanced Phase:
In the Advanced Phase, Group B incorporates additional resistance, performing Eccentric Heel Drops with Load. This involves adding weight or resistance to increase the intensity. It is done for 3 sets of 10 repetitions, 3 times per day, with 2 minutes rest between sets. The total time for this exercise is 15 minutes each session, and the intensity is high.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with insertional Achilles tendinopathy History of illness for about 2-3 months |
|
| ExclusionCriteria |
| Details |
Recent surgery on Achilles tendon
Other lower limb pathologies like calcaneal fracture, tibial fracture, etc
Cancer, malignancy, skin condition, etc
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, Range of motion and Functional ability |
Baseline before intervention, follow-up assessment after sixth week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included sidaman25@gmail.com).
- For how long will this data be available start date provided 17-06-2025 and end date provided 16-05-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Insertional Achilles tendinopathy (IAT) is a common condition that affects athletes and non- athletes alike, leading to significant pain, reduced range of motion, and impaired functional ability. Traditional treatments for IAT often include rest, anti-inflammatory medications, and physical therapy, but recovery can be prolonged, and symptoms may persist or recur. There is growing interest in the use of exercise-based interventions, particularly concentric (muscle shortening) and eccentric (muscle lengthening) loading exercises, for managing IAT. However, the relative effectiveness of these two types of exercises in reducing pain, improving range of motion, and restoring functional ability in patients with IAT remains unclear. Understanding the impact of concentric versus eccentric loading is crucial for developing optimized rehabilitation protocols, which can lead to better patient outcomes and more efficient use of healthcare resources.
AIM The aim of this study is to evaluate the impact of concentric and eccentric loading exercises on pain, range of motion, and functional ability in patients diagnosed with insertional Achilles tendinopathy. OBJECTIVE
1. To examine the impact of concentric loading exercises (on Achilles tendon) on pain, range of motion and functional ability in insertional Achilles tendinopathy. 2. To examine the impact of eccentric loading exercises (on Achilles tendon) on pain, range of motion and functional ability in insertional Achilles tendinopathy 3. To compare the impact of concentric and eccentric loading (on Achilles tendon) on pain, range of motion and functional ability in insertional Achilles tendinopathy. HYPOTHESIS Null hypothesis- 1. Null Hypothesis (H01): There is no significant impact of concentric loading exercises in pain, range of motion and functional ability in patients with insertional Achilles tendinopathy. 2. Null Hypothesis (H02): There is no significant impact of Eccentric loading exercises in pain, range of motion and functional ability in patients with insertional Achilles tendinopathy. 3. Null Hypothesis (H03): There is no significant impact of Concentric loading and Eccentric loading exercises in pain, range of motion and functional ability in patients with insertional Achilles tendinopathy. Alternate Hypothesis- 1. Alternative Hypothesis (H11): There is significant impact of concentric loading exercises in pain, range of motion and functional ability in patients with insertional Achilles tendinopathy. 2. Alternative Hypothesis (H12): There is significant impact of Eccentric loading exercises in pain, range of motion and functional ability in patients with insertional Achilles tendinopathy. 3. Alternative Hypothesis (H13): There is significant impact of Concentric loading and Eccentric loading exercises in pain, range of motion and functional ability in patients with insertional Achilles tendinopathy.
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