Study Design and setting- An Experimental, double blinded randomized controlled trial would be conducted at the Body and Soul Sport Complex, Gulf Medical University, UAE.
Inclusion Criteria
1.Age group- older adults within the age group 40 years − 70 years would be recruited for the study. The definition for older adults in this study has been given as per the operational definition. Since participants with non -communicable disease would be recruited, a lower age group of 40 years has been considered whereas to avoid ageing effects and reduce the risk of injury upper age limit of 70 years would was set.
2.Both genders- we would focus to increase female participants as the data among older female adults is scarce.
3. Participants without a history of non-communicable disease and with non-communicable disease (diabetes mellitus, hypertension, and obesity only) would be taken. Healthy control group would be selected from participants without non-communicable disease itself based on randomization.
Exclusion Criteria
Any joint disorders, cancer, neurologically unstable, chronic alcoholic, active pregnancy and prior physically active participants would be excluded.
Sample Population and size
A total of 120 participants would be equally divided into three groups viz. (1) with non-communicable diseases (WCN, n = 40) and (2) without non-communicable diseases (WICN, n = 40) and healthy control (HCG, n = 40). The sample size was calculated using formula for comparison of means with power of 80% power for a two-sided test with a level of significance of 0.05 and an effect size of 0.5 [10]. The total calculated sample size was 98. Considering 20% of dropouts, the final sample size for the study would be 120 with 40 in each group. Initial screening of participants would be done to consider them in either group i.e., with non-communicable (based on recent medical history and investigation for diabetes, blood pressure, BMI not more than six months) or without non communicable, and healthy control (age, gender matched). Without non-communicable and healthy control would be double blinded and randomly selected for badminton session using simple randomization technique. Those not selected under WICN group, would be considered under the healthy control group. The recruitment and allocation would be done by a registered physical therapist who would be supervising the session.
Study Procedure
Both the groups (with non-communicable disease and without non-communicable disease) would engage in badminton sports as per the specific inclusion and exclusion criteria. Confidentiality of the participant’s information would be maintained without revealing the identity of any individual for data analysis. Following to this, participants would be recruitment under purposive sampling from all seven emirates of the United Arab Emirates. WCN and WICN groups would be allowed to play Badminton in the University indoor court for 45–60 minutes per day. The protocol would be followed for 3 days a week at mild to moderate intensity under a supervised coach and physiotherapist for 2 months duration (8 weeks) [11]. The baseline physical activity and exertional level would be monitored for each participant using the IPAQ and Borg’s scale respectively. The comparative changes in the cardiovascular and neuromuscular parameters shall be done at the baseline value and post 2 months. The study procedure has been schematically presented in Fig. 1 below.
Participant Preparation
All participants would be instructed to follow suitable sports clothing for each badminton session. Non-marking shoes would be provided to each participant in line with the instructions for use of indoor badminton sports court. A participant information sheet would be given to all participants to understand the procedure and details of the required protocol for the session. Information regarding the precautionary measures and contact for help would also be provided to all participants considering the risk of general injury to all and exercise induced hypoglycemia among participants with non- communicable diseases. The testing procedure would be conducted free to all participants and informative feedback and consultation would be given to each participant toward their physical health and activity level. This could help to enhance the adherence and commitment to the research. The participants in the WCN and WICN would be restricted to use only Badminton as their physical activity and not allowed to play any other outdoor games during the trial period to avoid biasness in the result findings. Any adverse events during the trial would be immediately reported. The study setting has associated tertiary care hospital to manage any such events. The present study protocol has been reported using the SPIRIT guidelines [12] and schedule of the recruitment, allocation and intervention is shown in the schematic diagram below (Fig. 2).
Outcome Variables
The primary outcome variables of the study would consist of Cardiovascular and Neuromuscular parameters as listed below
Cardiovascular Parameters:
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estimated Vo2 max
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6 minutes’ walk distance
Neuromuscular Parameters:
Lower and Upper limb muscle strength
Lower limb muscle length
Agility
Lower Limb Joint Power- hip, knee and ankle
Muscle peak force for Quadriceps and Hamstring
Proprioception
Balance and Coordination
Reaction time
Hand eye-coordination
Statistical Analysis
The descriptive analysis would be done for demographic data in all groups followed by the test for normality. If the data is normally distributed, a parametric test i.e. paired and unpaired test would be used for the statistical comparison within and between groups using SPPS package V21. If the data is not normally distributed equivalent nonparametric test would be conducted. The post hoc test would be conducted to find larger differences between the specific groups. The effect size would also be conducted using Cohen’s d for better understanding of the results in clinical practice. The data analyst would be blinded towards allocation of the specific group. The data would be stored in a hard drive at the university research database. Any missing data would not be included for data analysis and needs to be excluded from the results.
Data Acquisition
The outcome variables suggested above would be acquired for all three groups as explained below
The lower limb joint power will be calculated using the inverse dynamics at the BTS force plate during the gait analysis with 8 video cameras (BTS SMART-DX system) [13]. Retroreflective markers will be placed on the joint centers using the Halen Hayes MM model. All the participants will be asked to walk at their normal speed from a set start line. Three successful trials will be taken and the peak power at hip, knee and ankle will be taken for data analysis.
The peak muscle force for Quadriceps and Hamstring will be calculated through the isokinetic device (Isomove, TecnoBody, Italy) with flexion angle set at 90 degrees and extension at 0 degrees (Torque 60 deg. Sec− 1) [14]. Participants would be instructed to generate their max force of push for the Quadriceps and pull for the Hamstring. Three complete cycles will be taken, and the peak muscle force will be used for data analysis.
The proprioception and balance will be calculated using the ProKin device( PK 254,TecnoBody, Italy) while standing on the embedded vowel board [15]. The participants will be asked to stand barefoot with eyes closed and with eyes open for stability assessment on both right and left lower limb respectively. The stability will be assessed in the Antero -posterior (A-P) and Medio-Lateral (M-L) directions. Proprioception will be assessed for individual limb while creating a 360-degree arc using the different compartments of foot stable over the platform.
The reaction time and hand eye coordination will be calculated using the D Wall system (TecnoBody, Italy) where specific task will be given to all participants [16].
The assessment for six-minute walk test will be done using the standard guidelines given by American Thoracic Society over a 15 m walkway [17]. Agility would be tested with Modified T Test [18]. Muscle length for quadriceps, hamstrings, gastro-soleus, and shoulder range of motion would be assessed using physical therapy clinical examination. Muscle strength for upper and lower limbs would be conducted using Oxford Manual Muscle strength grading method [19]. Participants would be encouraged to adhere to the intervention and allowed to skip the session for maximum 2 consecutive times (one week) for any unforeseen reasons after which they would be not included for data analysis. The participant who wishes to discontinue the project for any reason would be allowed at any stage and alternative participant would be recruited.