Trial design
Our study was a parallel-group, assessor-blind randomised controlled trial (RCT) for 12 weeks from July 2020 to October 2020 in a nursing home.The study had two groups:group 1,control (usual care)group;group 2, experimental (OEP) group. Control group received usual care, including health education and basic exercise,while participants in the OEP group received 12-week group OEP training for 30 min per session, three sessions per week. The study was registered in the Chinese Ethics Clinical Trials Registry ( Registration Number - ChiCTR2000039592- Date of Registration 02/11/2020. Accessed on http://www.chictr.org.cn/index.aspx).
Participants
The study was conducted in two groups randomly selected from a nursing home for elderly people suffering from cognitive frailty in Changsha,China.Participants who were eligible for the trial were required to comply with the following criteria:age,≥75 years;Fried scores≥1[14];the Beijing version of the Montreal Cognitive Assessment (MOCA-BJ) scale score ranged 19–25[26];able to perform OEP as determined by a physiotherapist;resident in the nursing home for more than 3 months; literate; and willing to participate.The exclusion criteria were: suffering severe diseases, such as paralysis, severe heart disease, or fractures,and participating in another clinical exercise study;Participate in other exercise intervention.
Interventions
An active interventions were received for both groups for 12 weeks in total.The same interventions in two groups included 30 min of health education at least once a month covering exercise knowledge,the benefit of exercise, recommendations of physical activity for older people, and how to exercise scientifically, based on a Chinese exercise book. In addition, we provided sleep- and diet-related information.Before and after each workout, participants’ vital signs were monitored,which were contains blood pressure,heart rate,temperature, and oxyhemoglobin saturation. If the oxyhemoglobin saturation was lower than 90%,the blood pressure was lower than 90/60 mmHg or higher than 140/90 mmHg,Participant was required to stop the exercise and called a doctor for treatment[27].
The subjects were randomly assigned to one of the two groups:
Group 1,control (usual care)group: The programme included health education and the elements of active.participants were asked to maintain their regular activity habits and requested not to receive another intervention exercise programme during the study period.
Group 2, experimental (OEP) group:In addition to sleep- and diet-related information as the control group, we provide 12 weeks of group OEP training, with a frequency of three sessions a week at 30 min per session.
The OEP were performed the following scheme:5 min warm-up, 10 min resistance training and 15 min balance exercise.The OEP was guided by a physiotherapist who had rich experience with the elderly. Each movement had different levels, and different requirements. 5 min warm-up included head and neck exercise, body warm-up, and ankle warm-up. 10 min resistance training included knee extensors, knee flexors and hip abductors (repeated as they could or 10 times), ankle plantarflexors and ankle dorsiflexors(10 repetitions, using a handrail or not),and Sandbags weighing about 0.5 kg were used. 15 min balance exercise comprised knee bends, backwards walking, ‘8’ shape walking, sideways walking, tandem stand, heel-toe walking, one-leg standing, heel walking, toe walking, backwards heel-toe walking, sit-to-stand exercises and stair walking[24]. Physiotherapists guided participants to increase or decrease the exercise level according to an exercise level table. More detail is available from the Otago Medical School website (www.acc.co.nz/otagoexerciseprogramme)[27].
Outcome measures
Data were collected at baseline and 6 weeks and 12 weeks after the beginning of the intervention.Data regarding age,gender,marriage status,education, religion,Body Mass Index(BMI) and comorbidity was taken from gathered during interviews with the participants by trained research assistants who were blinded to group assignment.
Physical frailty was assessed by Fried phenotype including five domains: unintentional weight loss; exhaustion,drawn from the Center for Epidemiological Studies Depression scale(CESD)[28], with answers of more than 3 days considered as exhaustion; low physical activity according to the Minnesota Questionnaire Assessment Scale[29]; weak muscle strength as evaluated by hand strength, which was measured by using electronic hand dynamometer (Zhongshan Camry Electronic Co. Ltd, Guangdong, China) and slowness was evaluated by gait speed, which was identified by measuring the time needed to walk 4.6 m as quickly as possible. Weak muscle strength and slowness cut-off points were based on sex and BMI respectively[30]. Participants were classified as frail (presence of three or more criteria), pre-frail (presence one or two criteria) or robust (no criteria).
Cognitive function was measured using the Beijing version of the Montreal Cognitive Assessment (MOCA-BJ) scale. The test covers seven domains: visualisation/executive functions (maximum is equal to 5), naming (maximum is equal to 3), attention (maximum is equal to 3), language facilities (maximum is equal to 3), delayed memory (maximum is equal to 5), abstraction (maximum is equal to 2) and orientation (maximum is equal to 6)[26]. The total MOCA-BJ score ranges from 0 to 30 points, and scores between 19 and 25 indicate MCI.
Barthel Index was used which were translated and adapted in Chinese to evaluate ADL.Barthel Index comprises 10 items,they are feeding, bathing,make up, dressing, controlling bowel,controlling bladder,personal toileting, moving from wheelchair to bed and returning,walking on level surface, and ascending and descending stairs.The total score ranges
between 0 and 100 (the lower the score, the greater the dependence)[31].
Ethics
The study protocol was approved by the Ethics Committee of Xiangya Nursing School of Central South University,China (No. E202042). The elderly gave their informed consent to participate in the research project.
Randomization
A random number table was used to randomly divided these participants into two equal-sized
Groups (31 participants in each group). The participants and physiotherapist were unable to be blinded, but the outcome evaluation and data analysis assessor were blinded to the randomization.
Statistical methods
SPSS version 18.0 was used to perform all data analyses.Descriptive statistics were used to describe and compare participants' baseline demographic data between groups. Continuous and categorical variables were described by Mean ± standard deviation and percentage. The differences between two groups were used to assess by Two-sample t tests, Kruskal–Wallis tests, and chi-square tests. The outcomes were measures by Repeated measurement (group × time). Analyses were assessd at a 0.05 level of significance.