Physical Activity with Sports Scientist (PASS) programme to promote physical activity among patients with non-communicable diseases: a pragmatic randomised controlled trial protocol

Study design and setting

The study design is a pragmatic randomised controlled trial (RCT). Two parallel groups with a 1:1 allocation ratio and a superiority framework will be employed. The control group will be usual care. The intervention group will consist of usual care and a PA programme led by a sports scientist (PASS). The study will be conducted at a single hospital-based outpatient clinic (Family Medicine Clinic, Walailak University Hospital) between March 2024 and March 2025.

Participants and sample size

The inclusion criteria will include patients who (1) are aged 35–70 years, (2) have at least one of the following NCDs: type 2 DM, HT and dyslipidaemia and (3) are physically inactive (<150 min/week of moderate-intensity aerobic PA or <75 min/week of vigorous intensity of aerobic PA or <150 min/week of moderate to vigorous-intensity PA (MVPA)). The exclusion criteria were patients who (1) have the presentation or history (since the last medical consultation) of fasting plasma glucose ≥300 mg/dL,22 hypoglycaemic symptoms, blood pressure ≥180/105 mm Hg22 or muscle pain from lipid-lowering medication use, (2) have a history of any of the following symptoms in the last 3 months: chest pain, palpitation, syncope, dyspnoea, alteration of consciousness, ankle oedema, (3) are pregnant or are currently breast feeding, (4) have adverse drug reactions due to drug interactions or polypharmacy, (5) have uncontrolled chronic respiratory disease, such as asthma, chronic obstructive pulmonary disease, (6) have movement limitations (eg, using walking aids, muscle weakness) and (7) have another individual residing in the same household as a study participant.

The sample size was calculated using a sample size calculator software, n4Studies, for RCTs using binary data.23 The proportions of meeting PA recommendations after the PA intervention were obtained from a previous RCT (Crapperton et al, 2020) included in a systematic review24 in which 78% of participants in the intervention group (p_intervention=0.78) and 51% in the control group (p_control=0.51) achieved PA recommendations. Using a type I error of 0.05, type II error of 0.2 and an allocation ratio of 1:1 (intervention to control group) resulted in a sample size of 49 in each group. Accounting for a 20% dropout rate, the final sample size was 60 in each group.

Recruitment and informed consent

Patients attending the Family Medicine Clinic at Walailak University Hospital have their blood drawn and other investigations completed at the laboratory or radiology units before this clinic visit. On registering at a registration station in the Family Medicine Clinic, the patients meet a nurse who interviews them for their medical history at the preconsultation station. During this time, the nurse will check for eligibility criteria for the study. Patients who meet the criteria will be contacted in person at the waiting area by a research assistant, who will provide them with details of the research project by providing them with a patient information sheet and inviting them to participate. Participation in the study is voluntary and will not affect normal care, nor will there be extra requests for blood tests, appointments and service fees. Patients who agree to participate will be asked to provide their written informed consent. This process will continue until 120 participants (60 in each group) have been recruited.

Outcome measurement and instrument

The primary outcomes are the proportion of patients meeting the PA recommendations, including aerobic, muscle-strengthening and multicomponent PA.25 The aerobic PA recommendations will be assessed using the Exercise Vital Sign (EVS). The Thai translation includes both PA and exercise to make sure everything is clear. Hence, PA is a less common term in the Thai language.6 Therefore, the Thai translation of the following questions will be used by nursing staff: (1) ‘on average, how many days per week do you engage in moderate to strenuous PA or exercise?’ or (2) ‘on average, how many minutes per day do you engage in moderate to strenuous PA or exercise?’26 27 Multiplicating the results from the two questions provides the amount of MVPA per week. The EVS is considered a valid questionnaire with excellent reliability (intraclass correlation coefficient 0.98, p<0.01) compared with the accelerometer.27 The value <150 min/week is considered ‘not meeting the recommended PA’, while ≥150 min/week is ‘meeting the recommended PA’.25 The result will be translated into a dichotomous variable (meeting PA recommendations; not meeting PA recommendations). For other types of PA, the questions regarding participation in (1) ≥2 days/week of moderate or greater intensity of muscle-strengthening activity and (2) ≥3 days/week of moderate or greater intensity of multicomponent PA will be inquired.

Secondary outcomes include body composition and physical fitness. A sports scientist will measure the body compositions using bioelectrical impedance analysis (Tanita model SC330P; Tanita, Tokyo, Japan). The participant’s information, such as age (years), sex (male or female) and body height (cm), will be inputted. The participant will be invited to stand on the footplate of the machine without socks and shoes. The weight of clothing will be discounted by 0.5 kg as per the machine’s default setting. Data, including body weight (kg), body mass index (kg/m²), fat mass (kg), percentage of fat (%), muscle mass (kg) and percentage of muscle mass (%), will be recorded in the participant record form (table 1).

Health-related physical fitness, including (1) flexibility (sit and reach for 35–59 years and back scratch for 60–70 years), (2) muscle strength and endurance (60 s chair stand for 35–59 years and 30 s chair stand) and (3) cardiovascular endurance (3 min step up and down for 35–59 years and 2 min step up and down for 60–70 years), will be assessed by a sport scientist in an available room at the clinic area. The methods and equipment for each test will follow the Thailand Department of Physical Education’s manual.28 The standard criteria for age and sex will be used to indicate ‘pass’ or ‘fail’.28

Each participant will be assessed and followed up at the clinic for four in-person visits. Information on each visit will be recorded in a hard copy form. The record form will be transferred through the service flow through nursing stations, physician consultations and sports scientists. A specific form will be used for each visit (table 1).

Randomisation, allocation and blinding

The allocation sequences were generated using an online randomisation generator, Sealed Envelope (https://www.sealedenvelope.com/simple-randomiser/v1/lists). The allocation ratio was 1:1, and a research assistant applied the block size for randomisation. The intervention assignments using codes (two alphabets and one number) will be contained in the concealed envelopes. The physician will be blinded to the allocation and the block size (eg, blocks of 2, 4 or 6). After the PA assessment and physical fitness tests at visit 1, the sports scientist will be unblinded to the allocation. The data analysts (other research team members who are not the physicians at the clinic and the sports scientist) will receive the raw data from group 1 or 2 to blind the intervention assignments.

Intervention

Participants in the control group will receive usual care, including meeting a nurse at the preconsultation and postconsultation stations and routine physician consultations. Brief PA counselling and lifestyle modification advice will be discussed as usual. Follow-up appointments will be made on a normal basis. The participants in this group will meet a sports scientist to measure body composition and physical fitness tests.

Participants in the intervention group will receive usual care and a tailored PA programme per the WHO guidelines using the FITT Pro (frequency, intensity, time, type and progression) by a sports scientist at visit 1.25 29 The sports scientist will design and discuss the PA programme with the participants based on the physician’s brief counselling and the precaution. The programme will include aerobic, muscle-strengthening and multicomponent PA. The sports scientist will use videos to illustrate recommended activities. An appropriate resistant elastic band will be provided for each participant. The details of 2–4 sets and 8–15 reps/set of body weight exercises will be suggested for muscle strengthening based on the appropriateness and abilities of the participants.

The sports scientist will provide the phone number to contact the participant and inquire about a convenient time for further communication. A sports scientist will perform monthly phone follow-ups after visits 1 and 2 (figure 1). The phone follow-up will be missed if the sports scientist cannot reach the participant after the initial call and the subsequent day’s attempt.

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Data collection

Both control and intervention groups will be assessed for the primary (PA participation) and secondary outcomes (body composition and physical fitness) four times (figure 1). The length between each medical appointment is approximately 3–4 months. Data will be recorded using the participant record forms (table 1). The attending physician is a family medicine physician who is this study’s principal investigator (AW). The nursing staff at the clinic are part of the clinic team. A sports scientist (SM), a research team member, will be responsible for participant assessment and PA programme delivery. A research assistant will help contact and communicate with participants outside the physician’s consultation room.

The primary outcomes, including participation in ≥150 min/week of MVPA, ≥2 times/week of muscle-strengthening activity and ≥3 times/week of multicomponent PA, will be recorded as the categorical variables (‘yes’ or ‘no’). Participation in aerobic PA calculated from the EVS will be collected as a continuous variable (min/week). For secondary outcomes, all body composition components are continuous variables. The physical fitness tests are categorical variables (‘pass’ or ‘fail’). A research assistant will transfer the participant profile, PA participation, body compositions and physical fitness tests to Excel sheets (Microsoft, Redmond, Washington, USA).

Data analysis

Frequencies and percentages will present the categorical variables. The Shapiro-Wilk test will test the continuous variables for normal distribution. Variables with normal distribution will be presented by means and SDs. Otherwise, medians and IQRs will be presented.

The differences in outcomes of each visit between the control and the intervention groups will be tested by analytical statistics. The χ² or Fisher’s exact tests will be executed for categorical variables. The independent t-test will test the differences among the continuous variables. An alternative test for non-parametric statistics will be the Mann-Whitney U test. The statistical analysis will be performed in R V.4.0.2 (RStudio, Massachusetts, USA). The intention-to-treat analysis will be applied. The level of statistical significance is p<0.05.

Safety and monitoring

The research team will reduce and monitor the potential risks across the study period. Hard copy participant record forms are used to avoid unauthorised access to electronic medical records. The research assistants, coresearchers from other institutions and sports scientists will not be allowed to access the electronic medical records to keep data private. All hard copy and electronic documents will contain participant codes instead of identifiable information, except the informed consent form and the separate participant code book.

Safety issues and adverse events (eg, falls, hypoglycaemia, pain, shortness of breath, chest pain) related to the assessment and intervention will be monitored by the physician and the sports scientist at every visit and follow-up call. Participants will be advised to discontinue the intervention or seek medical care if there are concerns about risks, harm and safety issues. Participants will be informed of the research team and the human research ethics committee’s contact to report any risks, harms and safety issues.

In addition, if there is a need for first aid or urgent medical care, the principal investigator and nursing staff will evaluate the participant in the clinic area. Consideration for a referral to the emergency department or hospital admission will be based on the severity and urgency of the event. Adverse events outside the clinic will be recommended for management according to standard care protocols (eg, self-care, clinic visits, ambulance calls).

Patient and public involvement

Six individuals living with NCDs were invited to a patient and public involvement (PPI) group, representing diverse sociodemographics (eg, business owners, retired teachers, retired bankers and non-academic university staff). The research team presented the summary of the study protocol to the group at a meeting on 8 January 2024. The PPI group discussed the protocol and research materials (ie, participant record forms). This process was not part of the data collection. This meeting aimed to obtain comments from patients on the feasibility of the study processes and the need for improvement. After the meeting, the research team amended the protocol and materials based on suggestions from the PPI group. The study protocol was revised before the submission to the human research ethics committee. After the completion of the study, a discussion on the findings will be held with the PPI group to gather more insights. The PPI group will be invented to disseminate the findings to key stakeholders, for example, patients and healthcare professionals.

Research ethics and dissemination

The trial registration was submitted to the Thai Clinical Trials Registry (registration number: TCTR20240314001).

The study processes will follow the study protocol, and any protocol amendments will be submitted to the Human Research Ethics Committee of Walailak University. All documents will be kept confidential.

The study protocol will be published in an academic journal. The study results will be disseminated via conference presentations, reports to the grant funder, websites or social media and publications in peer-reviewed journals. The presentation of the study will keep the anonymity of participants.