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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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