This was a 2-arm parallel design, single-blinded, single-center randomized controlled trial approved by the Ethical Committee of Riphah International University (RCRS-RE-PHD-RS/Fall19/127). The trial was registered at the Iranian Registry of Clinical Trials (trial ID IRCT20221005056094N1). The date of registration was October 25, 2022. All participants signed written informed consent before participating in the study. The participants were also informed that the study intervention had no disadvantages or risks. Careful monitoring of the participants was performed throughout the study, and necessary medical care was provided to the participants when needed. The participants were also informed that they could withdraw freely. During the entire study process, the identities of the participants were not disclosed in any publication of this study. The patient may choose not to participate in the study and withdraw their consent to participate at any time and will not be penalized in any way if they choose not to participate or withdraw from this study. The study was conducted according to CONSORT (Consolidated Standards of Reporting Trials) [27], and included the CONSORT checklist (Checklist 1).

Participant recruitment and all study activities, including follow-up, were conducted between March 2022 and August 2022. The trial comprised a 12-week intervention phase immediately followed by a 12-week no-intervention follow-up period, with final assessments completed in August 2022. All primary and secondary outcomes, including those related to potential benefits and harms, were measured at baseline, during the intervention, post intervention, and at follow-up.

The data were collected at the outpatient department of the University Teaching Hospital, UOL, and in Lahore, Pakistan. A nonprobability convenience sampling technique was used to collect data from the geriatric population. The inclusion criteria were participants aged 65 to 75 years, including both male and female participants; those who could move independently and climb a flight of stairs independently; those who have thoracic kyphosis of 50 degrees or greater; and those who have cognitive function within normal limits, assessed by Mini-Mental State Examination ≥24. The exclusion criteria were participants who could not maintain balance when standing unassisted; those with diagnosed neurological or vestibular disorders; and those with serious medical conditions that would limit participation in the exercise program, that is, chest pain, myocardial infarction, or cardiac surgery within 6 months. Participants with uncontrolled hypertension and with a history of hip fracture or total hip replacement within the previous 12 months (due to its potential effect on balance and mobility outcomes) and those who used assistive devices for walking (eg, cane or walker) in daily activities were also excluded.

The intervention consisted of a 24-week exercise program. The treatment was applied twice weekly for 12 weeks, after which follow-up readings were taken for the next 12 weeks. Data from both the intervention group and the control group were obtained by the researcher at 6 different times: at baseline (T0) for 3 months (T1, T2, and T3), and then for the next 3 months (T4, T5, and T6) for follow-up visits. The details are shown in Table 1.

Postural education included instructions for maintaining the correct posture (5 min).

The cool-down period consisted of stretching and relaxation exercises (10 min), and a progressive approach was used in all the multicomponent exercises.

A progressive approach was used in all the multicomponent exercises. On the basis of a gradual increase in training volume, sets, and repetitions, we intended to gradually include participants with a variety of different exercise levels.

A detailed description of the exercise program is given in Table 2.

Four primary outcome measures were used to evaluate the effects of the MBIEX intervention.

The study sample size was estimated on the basis of the mean and SD reported by Szturm et al [38] for the balance scale. An open-source online calculator (OpenEpi V.3.00) was then used to estimate the total sample size as 91 patients. To account for potential attrition, an anticipated dropout rate of 20% was incorporated, consistent with rates reported in previous longitudinal exercise intervention studies involving older adults [39]. This adjustment was made to minimize the risk of reduced statistical power due to participant loss from health-related issues, personal circumstances, or loss to follow-up. Accordingly, the final estimated sample size was 113 patients, with 56 allocated to the experimental group and 57 to the control group. A 95% CI (α) and 80% power were used in the calculation.

Participants were recruited using convenience sampling and randomly assigned to 1 of 2 groups using the simple lottery method. Each participant was given a unique identification number by the principal investigator, which was written on identical slips of paper and sealed in opaque envelopes. These envelopes were thoroughly mixed and placed in a box. A research assistant—independent of the recruitment, treatment, and assessment process—randomly drew envelopes to assign participants to either group, thereby ensuring allocation concealment and maintaining a 1:1 ratio between groups.

Due to the nature of the interventions, blinding of the participants and treating therapists was not feasible. However, to minimize detection bias, the outcome assessor remained blinded to group allocation throughout the study. Additionally, the data provided to the statistician were anonymized and coded (eg, as group A and group B) to ensure blinding during analysis.

All statistical analyses were performed using SPSS version 26 (IBM Corp.). Continuous variables such as age, weight, and height were reported as mean (SD). The normality of the data was checked with the Kolmogorov-Smirnov test. For comparisons between groups at each time point (baseline, 3 mo), we used the Mann-Whitney U test. For within-group changes over time (eg, baseline vs 3 mo), we applied the Wilcoxon Signed-Rank Test. When more than 2 time points were compared within a group, we first ran the Friedman test, followed by pairwise Wilcoxon tests with Bonferroni correction to adjust for multiple comparisons. In addition to P values, effect sizes (r) were calculated for all nonparametric tests using the formula r=Z/√N (n=number of observations in the test), along with 95% CIs for r to provide an estimate of the magnitude and precision of effects. Statistical significance was set at P<.05.

The study was approved by the Ethical Committee of Riphah International University (RCRS-RE-PHD-RS/Fall19/127). All participants signed written informed consent before participating in the study. The subjects were also informed that the study intervention had no disadvantages or risks. Careful monitoring of the participants was performed throughout the study; necessary medical care was also provided to the participants when needed. During the entire study process, the identities of the participants will not be disclosed in any publication of this study. The patient may choose not to participate in the study and withdraw their consent to participate at any time and will not be penalized in any way if they choose not to participate or withdraw from this study. All the participants participated voluntarily in the study.

Completed personal data or other documents containing protected personal health information were kept in a locked file at the principal investigator’s office. The data were entered into an electronic deidentified database by authorized study team members and checked for completeness and accuracy. Access to data with identifiers was restricted to authorized study team members and authorities. The electronic data were kept on a server regulated by the local research institute. Data will be destroyed 10 years after the study’s finalization or 5 years after the last publication.

Figure 1 provides a detailed overview of participant enrollment, allocation, follow-up, and analysis. A screening of 410 healthy older individuals was performed for participation in the study. After the exclusion of 297 participants, 113 fulfilled the inclusion criteria of the study. Fifty-seven participants were allocated to the control group, and 56 were allocated to the exercise group. During the study, 13 participants dropped out, and 100 participants completed the study for 24 weeks. The overall schematic flow of the patient sample is given in the CONSORT guidelines. There were no statistically significant differences between the groups in terms of demographic or clinical characteristics at baseline.

Descriptive statistics of gender, age, sex, weight, height, and BMI were included as the means and SDs and are summarized in Table 3.

Table 3 shows that the groups were comparable in terms of gender distribution, age, height, weight, and kyphosis angle, with no statistically significant differences observed (P>.05). A significant difference was noted for BMI, which was slightly higher in the exercise group compared to the control group (P=.04).

Table 4 summarizes the between-group comparisons of all primary outcome measures using the Mann-Whitney U test. The exercise group demonstrated significantly greater improvements than the control group in TUG (U=161.00; P<.001; r=0.65, 95% CI 0.45‐0.80), tragus-to-wall test (TWT; U=654.00; P<.001; r=0.52, 95% CI 0.30‐0.70), Mini-BESTest (U=560.00; P<.001; r=0.48, 95% CI 0.25‐0.66), and postural sway (U=480.00; P=.002; r=0.40, 95% CI 0.18‐0.58). The magnitude of effect sizes suggested a moderate-to-large effect of the intervention on mobility and balance outcomes.

Table 5 presents the within-group changes in functional performance and postural control outcomes for the exercise and control groups across baseline, month 1, month 2, and month 3 assessments. Both groups demonstrated statistically significant improvements in TUG, TWT, Mini-BESTest, and postural sway (P<.001 for most outcomes), with the exercise group showing larger effect sizes (r=0.71‐0.80) compared to the control group (r=0.40‐0.70). The exercise group exhibited the greatest gains in mobility and balance measures. Table 5 shows between-group comparisons of all primary outcome measures using the Mann-Whitney U test. At postintervention 3, the exercise group performed significantly better than the control group on the TUG test (median 10, IQR 8-12 vs 12, IQR 10-14 seconds; U=161.00, P<.001; r=0.65, 95% CI 0.45-0.80), TWT (49, IQR 44-54 vs 37, IQR 31-43 cm; U=654.00, P<.001; r=0.52, 95% CI 0.30-0.70), Mini-BESTest (27, IQR 24-30 vs 18, IQR 16-21 points; U=560.00, P<.001; r=0.48, 95% CI 0.25-0.66), and postural sway (2.2, IQR 1.8-2.6 vs 2.8, IQR 2.4-3.3 cm; U=480.00, P=.002; r=0.40, 95% CI 0.18-0.58). These findings suggest moderate-to-large intervention effects for mobility and balance outcomes. These results indicated that the MIBEX effectively enhanced postural stability and functional mobility over the intervention period.

Adherence to the intervention was tracked using attendance logs maintained by the treating physiotherapist. Participants were encouraged to attend at least 75% of scheduled supervised sessions over the 12-week intervention period, followed by a 12-week follow-up (no adherence data were collected during the follow-up). Adherence rates for both groups during the 12-week intervention period are presented in Table 6. The intervention group maintained high attendance (92% at wk 4% and 87% at wk 12), whereas the control group’s adherence declined from 78% to 70% over the same period.

Adverse events were monitored throughout the intervention period by the treating physiotherapist and during each exercise session. Participants were instructed to promptly report any discomfort, injury, or health-related incidents at any time during the study. No adverse events were reported by participants in either the experimental group or the control group during the study period.

This study focused on assessing the impact of a multisystemic exercise program on the physical function of community-dwelling older adults. This study revealed that a multisystemic exercise program, including low-to-moderate intensity resistance, cardiorespiratory, balance, strength, and flexibility training, along with postural education and an increase in moderate-to-vigorous intensity exercise performed twice a week for 24 weeks, significantly improved physical function and reversed the decline in function associated with aging. These findings support the original hypothesis that an exercise intervention positively and substantially affects physical fitness in community-dwelling older adults.

The participants in this community-based exercise program achieved considerable gains in multiple functional capacities with minimal investment in equipment compared with conventional strength and/or cardiorespiratory training using costly devices [6]. The improvements were similar to those reported in a recent review of 28 studies on resistance training [40]. Consequently, multicomponent exercise programs may be beneficial, as there is a clear connection between high physical activity and low sedentary behavior, as well as improved muscle strength in physically active older adults [41]. Meta-analyses of recent research have shown that multicomponent exercise programs effectively enhance various aspects of health-related physical fitness [14,38].

The multicomponent exercise program significantly improved lower and upper limb strength. This improvement is likely due to the stimulus provided by the exercise program and the adherence to the exercise prescription guidelines [42]. As participants perform strength exercises, they place demands on their muscles, which stimulates muscle fibers and leads to an increase in muscle strength. Progression training increased over the 24 weeks during which participants performed more upper limb and lower limb exercises. These findings align with those of the Beck Jepsen et al study [43], and they support the results of a recent meta-analysis that emphasized the importance of multiple sets in producing benefits in muscle strength [44].

A systematic review of randomized clinical trials with frail older patients revealed conflicting data regarding improvements in the risk of falls, mobility, balance, strength, functional capacity, and body composition [45]. Even among those who showed improvements in functional capacity, attributing the success of these results to a specific element of the intervention protocol is not appropriate.

In addition, multiple systematic reviews have shown that the multicomponent training regimen, comprising sessions that last 30 to 45 minutes and are conducted 3 times per week, is the most commonly recommended protocol for exercise among frail older adults [46]. Specifically, multicomponent exercise programs that incorporate resistance, balance, and flexibility exercises are highly effective for this population [41,42]. Our study is consistent with these findings, as we used 60-minute exercise sessions twice weekly for a 24-week duration. A year ago, a study in which a TWT was used to measure the altered angle was conducted to investigate the effects of exercise programs on age-related kyphosis. A comparison of the preintervention and postintervention values of the occiput-to-wall test revealed a significant difference after the protocol was administered (P<.001) [43], similar to our study’s results. Multicomponent exercise programs delivered in primary health care settings have been shown to improve postural control and muscle power in older adults, potentially helping to prevent falls and enhance quality of life, as demonstrated in a study with a similar design to ours conducted on healthy older individuals. The sample size of that study was small, with participants averaging 60 years of age [24].

The main strength of our study is that it uses a multicomponent exercise program (MIBEX), which appears to be a feasible, efficient, and cost-effective option for promoting physical activity among older adults in primary health care settings. This is because the exercises can be performed in groups, require inexpensive equipment, and can be modified to suit local characteristics. Additionally, our study uses a personalized exercise program tailored to individual characteristics and includes postural education.

This study had several limitations. First, it was not possible to blind participants, clinicians, or trainers in this type of exercise program. Although the outcome assessors were blinded to the groupings, some participants may have inadvertently revealed their treatment status, which could have affected the results. This study used a postural teaching program via video for the control group. However, there was no significant difference in the outcome measures since participants did not adhere to the activity, leading to a low rate of participation in the exercise sessions. Despite frequent stimulation and customized work, program adherence fell short of expectations.

Moreover, participation was entirely voluntary, and the main cause for exclusion was when participants refused to participate. As a result, the majority of participants may have established a positive relationship between exercise and health, which could have led to bias. Additionally, we could not determine whether participants who declined to participate would have benefited from physical activity as well.

Future studies should specifically consider the effects of exercise programs on physical performance by gender. Evidence suggests that older women may experience greater declines in physical function and show less pronounced improvements in strength and balance following exercise interventions compared to men [47]. Therefore, future research should account for sex as an important factor when designing and evaluating exercise programs, and may consider including balanced numbers of male and female participants to better assess gender-specific responses.

The current findings can be used to plan and implement future useful public health interventions for community-dwelling older individuals, which could reduce prospective healthcare expenses associated with disabilities among this population. Additionally, primary health care programs should aim to minimize barriers to physical activity promotion. Although recommendations from the literature should be considered in exercise programs for older adults, they may occasionally create barriers to the development of interventions. Nonetheless, socialization and recreational activities seem to be essential components in enhancing adherence among older adults and should be incorporated into multicomponent exercise programs.

The 24-week tailored exercise program had significant positive effects on improving physical function in older adults. The participants exhibited marked improvements in strength, flexibility, balance, and endurance, leading to better daily performance, increased mobility, and a reduced risk of falls. The personalized nature of the program ensured higher adherence rates and more meaningful outcomes, addressing various aspects of physical function for overall health and well-being.