| CTRI Number |
CTRI/2025/12/099776 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| 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
|
A study comparing cardio exercise and muscle power training exercise on heart health fitness and general well being in people with mild high blood pressure
health physical capacity and quality of life in patients with stage one high blood pressure |
|
Scientific Title of Study
|
Effectiveness of aerobic versus anaerobic exercise training on cardiovascular parameters, functional capacity, and quality of life among stage one hypertensive patients a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rutuja Kamble |
| Designation |
Assistant Professor |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
Block no 304 Third floor Department of Cardiovascular and Respiratory Physiotherapy TMVs Lokmanya Tilak College of Physiotherapy J block
Raghunath vihar sector 14 kharghar Navi mumbai
Raigarh MAHARASHTRA 410210 India |
| Phone |
9766918986 |
| Fax |
|
| Email |
rutujak35@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Abhijit Diwate |
| Designation |
Professor and HOD |
| Affiliation |
DVVPF College of Physiotherapy |
| Address |
Ground floor Department of Cardiovascular and Respiratory Physiotherapy DVVPF College of Physiotherapy vadgaon gupta ahilyanagar ahmadnagar
Ahmadnagar MAHARASHTRA 414111 India |
| Phone |
8554990222 |
| Fax |
|
| Email |
abhijitdiwate@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Abhijit Diwate |
| Designation |
Professor and HOD |
| Affiliation |
DVVPF College of Physiotherapy |
| Address |
Ground floor Department of Cardiovascular and Respiratory Physiotherapy DVVPF College of Physiotherapy vadgaon gupta ahilyanagar ahmadnagar
Ahmadnagar MAHARASHTRA 414111 India |
| Phone |
08554990222 |
| Fax |
|
| Email |
abhijitdiwate@gmail.com |
|
|
Source of Monetary or Material Support
|
| DVVPF College of Physiotherapy,Vadgaon Gupta,Ahilyanagar,Maharashtra-414111 |
|
|
Primary Sponsor
|
| Name |
Dr Rutuja Kamble |
| Address |
DVVPF College of Physiotherapy,Vadgaon Gupta,Ahilyanagar,Maharashtra-414111 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rutuja Kamble |
TMVs Lokmanya Tilak College of Physiotherapy |
Block no 304 Third floor Department of Cardiovascular and Respiratory Physiotherapy J block
Raghunath vihar sector 14 kharghar Navi mumbai 410210 Raigarh MAHARASHTRA |
9766918986
rutujak35@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMVs Lokmanya Tilak College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aerobic exercise training |
Participants will receive moderate intensity aerobic exercise training including warm up for five to ten minutes, followed by static cycling for twenty minutes at forty to sixty percent of heart rate reserve, three alternate days per week for eight weeks. Each session will end with cool down stretching exercises for five minutes. Blood pressure, heart rate, VO2 peak, IPAQ score and SF thirty six quality of life score will be assessed before and after eight weeks of intervention. |
| Intervention |
Anaerobic exercise training |
Participants will receive moderate intensity anaerobic (resistance) exercise training with a warm up of five minutes, followed by resistance exercises using dumbbells and weight cuffs for major upper and lower limb muscle groups. Each muscle group will perform two sets of eight to twelve repetitions with thirty seconds of rest between sets. Training will be conducted on three alternate days per week for eight weeks. Each session will conclude with five minutes of cool down stretching exercises. Blood pressure, heart rate, VO2 peak, IPAQ score, and SF thirty six quality of life score will be assessed before and after eight weeks of intervention |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged thirty to fifty years diagnosed with stage one hypertension for a minimum of six months. Individuals fit to participate as per PARQ scale and cleared for exercise by a physician. Low to moderate cardiovascular risk as per risk stratification. Patients on only one anti hypertensive medication. Both male and female participants. No history of respiratory disorder in the last six months. Ability to understand the purpose of the study and willing to participate voluntarily. |
|
| ExclusionCriteria |
| Details |
History of severe cardiac conditions such as angina, myocardial infarction, or cardiac arrest. Presence of obstructive or restrictive lung disease. Musculoskeletal disorders affecting six minute walk test performance. Uncontrolled hypertension above one sixty millimeter of mercury. Diabetes mellitus. Substance addiction including tobacco, smoking or alcohol. Obesity with body mass index above thirty. Major visual or auditory impairment. Neurological or neuromuscular disorders. Serious cognitive or psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in systolic and diastolic blood pressure from baseline to eight weeks |
Change in systolic and diastolic blood pressure from baseline to eight weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in resting heart rate |
Baseline and eight weeks |
| Change in peak oxygen uptake VO2 peak |
Baseline and eight weeks |
| Functional capacity measured by six minute walk distance in metres |
Baseline and eight weeks |
| Physical activity level measured by IPAQ score |
Baseline and eight weeks |
| Quality of life measured by SF 36 total score |
Baseline and eight weeks |
|
|
Target Sample Size
|
Total Sample Size="105" Sample Size from India="105"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
This randomized controlled trial evaluates the effectiveness of aerobic exercise training compared with anaerobic or resistance exercise training on cardiovascular parameters, functional capacity, physical activity level, and quality of life in middle aged individuals with stage 1 hypertension. Participants aged 30 to 50 years who have been diagnosed with hypertension for at least six months will be recruited from an Urban Primary Health Centre and a college outpatient department. After baseline screening and informed consent, eligible participants will be randomly allocated into two groups using computer generated random numbers with allocation concealment through sealed envelopes. Single blinding will be followed in which only the participants will be unaware of their intervention group. Group A will receive aerobic exercise training which includes warm up and cool down exercises along with static cycling for 20 minutes at 40 to 60 percent of heart rate reserve three days per week for eight weeks. Group B will receive anaerobic or resistance exercises which include warm up and cool down exercises followed by upper and lower limb strengthening using dumbbells and weight cuffs based on one repetition maximum. Vital parameters will be monitored throughout the sessions for participant safety. Outcome measures will be recorded at baseline and after eight weeks of intervention. Cardiovascular parameters include blood pressure and heart rate. Functional capacity will be assessed with the six minute walk test and VO2 peak. Physical activity level will be measured using the International Physical Activity Questionnaire IPAQ. Quality of life will be assessed using the SF 36 questionnaire. The study aims to identify which form of exercise provides greater improvement in cardiovascular health, physical activity, and quality of life in adults with stage 1 hypertension. |