Effects of Multimodal Training of Combined Cognitive and/or Physical Training on Cognition and Fitness of Older Adults (MTCCP)

Hong Kong Baptist University

Status: Unknown

Conditions: Cognitive Decline; Cognitive Impairment, Mild

Treatments: Behavioral: Cognitive training; Behavioral: physical training; Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP

Study type: Interventional

Funder types: Other

Identifiers

NCT04727450

12607620

Details and patient eligibility

About

The elderly population worldwide is expected to increase exponentially. There will be a higher percentage of older adults suffering cognitive decline in the coming decades. Cognitive impairment, being the most common health problem associated with ageing, contributes to possible loss of functional independence and disability. The purpose of this study is to determine the effectiveness of four mixed modalities of three training programs (combined cognitive and physical training [CCPT], cognitive or physical training only) on cognition and fitness of community-dwelling older adults in Hong Kong. The study hypotheses will be set as the integrated format of all three training will have higher cognition and fitness scores than other combinations of two training modes and all these mixed modalities will have greater positive outcomes than the active control subjects.

Full description

The study design is a cluster randomized controlled trial. Twenty-four elderly centers as clusters will be randomly selected and assigned to be intervention (n=20) or control groups (n=4) in two study phases. A total of 8-10 older adults (age ≥ 60) from each cluster (total subjects = 228) will be invited to be study participants. Each intervention cluster will receive either an integrated training format or one out of three combinations of two training modes. Each intervention training mode will last for 2-month of 16 sessions in total, 2 sessions per week and 60 min per session, hence, the total intervention will last for 4 months for two training modes or an integrated training format. Assessments will be conducted at pre-test, two post-training tests, and a 2-month follow-up test after completion of all training.

Enrollment: 228 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 60 or above
2. Both gender
3. Willingness and capability to participate in this study and training
4. Willingness and capability to give informed consent to participate in this study
5. Pass the cutting-point of referenced screening tests (cognitive and emotional)

Screening tools:

• MOCA score above 19 (satisfactory basic function)
• Positive and Negative Syndrome Scale (PANSS) with scores < 19 in positive scale, < 22 in negative scale, and < 38 in general psychopathology scale

Exclusion criteria

1. A history of systematic cardiovascular diseases, poorly controlled hypertension, stroke, Parkinson's disease
2. Early stages of Alzheimer's Disease, or the use of psychoactive drugs
3. Complicated conditions that preclude regular attendance of the training
4. Currently receiving regular physical (perform aerobic, flexibility and stretching exercises for 3 days per week, 45 minutes per session, for 1 year or longer) and cognitive exercises (such as playing mahjong, chess, bridge and reading for more than 30 minutes per session and 3 times per week, for 1 year or longer ).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

228 participants in 5 patient groups

1. Integrated format

Active Comparator group

Description:

Integrated or Combination of ABC of A: cognitive training. B: physical training and C: Combined Cognitive and Physical Training (CCPT).

Treatment:

Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP

Behavioral: Cognitive training

Behavioral: physical training

2. Cognitive training + Physical Training (A+B)

Active Comparator group

Description:

Intervention of A \& B treatments.

Treatment:

Behavioral: Cognitive training

Behavioral: physical training

3. Physical training + CCPT (B+C)

Active Comparator group

Description:

Intervention of B \& C treatments.

Treatment:

Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP

Behavioral: physical training

4. CCPT + Cognitive training (C+A)

Active Comparator group

Description:

Intervention of C \& A treatments.

Treatment:

Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP

Behavioral: Cognitive training

5. Control group

No Intervention group

Description:

No intervention